Trial Outcomes & Findings for Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis (NCT NCT05116540)
NCT ID: NCT05116540
Last Updated: 2025-09-26
Results Overview
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. The developers used the SF-36 as a base and added 18 questions to address MS-specific problems, including fatigue and cognitive function. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life).
COMPLETED
PHASE2
24 participants
Baseline to Week 52
2025-09-26
Participant Flow
Participant milestones
| Measure |
Treatment
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 10.57 • n=5 Participants
|
49.1 years
STANDARD_DEVIATION 12.17 • n=7 Participants
|
50.0 years
STANDARD_DEVIATION 11.19 • n=5 Participants
|
|
Age, Customized
|
51.0 years
STANDARD_DEVIATION 10.57 • n=5 Participants
|
49.1 years
STANDARD_DEVIATION 12.17 • n=7 Participants
|
50.0 years
STANDARD_DEVIATION 11.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Weight
|
68.61 kilograms
STANDARD_DEVIATION 17.493 • n=5 Participants
|
76.55 kilograms
STANDARD_DEVIATION 16.619 • n=7 Participants
|
72.58 kilograms
STANDARD_DEVIATION 17.172 • n=5 Participants
|
|
Baseline BMI
|
24.72 kg/m^2
STANDARD_DEVIATION 5.520 • n=5 Participants
|
27.17 kg/m^2
STANDARD_DEVIATION 5.723 • n=7 Participants
|
25.94 kg/m^2
STANDARD_DEVIATION 5.639 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. The developers used the SF-36 as a base and added 18 questions to address MS-specific problems, including fatigue and cognitive function. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life).
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument
Infusion 1/Baseline (Week 0)
|
53.85 score on a scale (100 points total)
Standard Deviation 9.61
|
44.07 score on a scale (100 points total)
Standard Deviation 10.95
|
|
Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument
Infusion 3 (Week 8)
|
8.21 score on a scale (100 points total)
Standard Deviation 13.08
|
7.03 score on a scale (100 points total)
Standard Deviation 10.76
|
|
Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument
Infusion 5 (Week 24)
|
6.68 score on a scale (100 points total)
Standard Deviation 7.33
|
3.43 score on a scale (100 points total)
Standard Deviation 11.00
|
|
Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument
Follow-Up (Week 42)
|
4.19 score on a scale (100 points total)
Standard Deviation 18.03
|
0.06 score on a scale (100 points total)
Standard Deviation 11.13
|
|
Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument
End of Study (Week 52)
|
15.98 score on a scale (100 points total)
Standard Deviation 12.08
|
2.03 score on a scale (100 points total)
Standard Deviation 10.62
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. The developers used the SF-36 as a base and added 18 questions to address MS-specific problems, including fatigue and cognitive function. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life).
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 1/Baseline (Week 0)
|
65.37 score on a scale (100 points total)
Standard Deviation 24.83
|
60.88 score on a scale (100 points total)
Standard Deviation 20.58
|
|
Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 3 (Week 8)
|
11.04 score on a scale (100 points total)
Standard Deviation 10.96
|
6.39 score on a scale (100 points total)
Standard Deviation 21.55
|
|
Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 5 (Week 24)
|
8.81 score on a scale (100 points total)
Standard Deviation 11.20
|
3.22 score on a scale (100 points total)
Standard Deviation 13.29
|
|
Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Follow-Up (Week 42)
|
5.48 score on a scale (100 points total)
Standard Deviation 17.96
|
-0.35 score on a scale (100 points total)
Standard Deviation 22.40
|
|
Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
End of Study (Week 52)
|
13.54 score on a scale (100 points total)
Standard Deviation 15.65
|
-2.59 score on a scale (100 points total)
Standard Deviation 22.21
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Cognitive Function subscale. The score ranges from 0 to 100 percent, and is 15% of the total Mental Health Composite Score.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 1/Baseline (Week 0)
|
59.55 score on a scale (100 points total)
Standard Deviation 39.27
|
64.50 score on a scale (100 points total)
Standard Deviation 36.32
|
|
Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 3 (Week 8)
|
10.45 score on a scale (100 points total)
Standard Deviation 23.29
|
6.50 score on a scale (100 points total)
Standard Deviation 16.67
|
|
Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 5 (Week 24)
|
5.91 score on a scale (100 points total)
Standard Deviation 10.91
|
5.50 score on a scale (100 points total)
Standard Deviation 14.80
|
|
Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Follow-Up (Week 42)
|
3.00 score on a scale (100 points total)
Standard Deviation 20.84
|
4.50 score on a scale (100 points total)
Standard Deviation 17.55
|
|
Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
End of Study (Week 52)
|
9.55 score on a scale (100 points total)
Standard Deviation 18.09
|
-2.50 score on a scale (100 points total)
Standard Deviation 10.07
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Emotional Wellbeing sub-scale. The score ranges from 0 to 100 percent, and is 29% of the total Mental Health Composite Score.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 1/Baseline (Week 0)
|
71.27 score on a scale (100 points total)
Standard Deviation 21.45
|
68.40 score on a scale (100 points total)
Standard Deviation 17.23
|
|
Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 3 (Week 8)
|
6.91 score on a scale (100 points total)
Standard Deviation 14.32
|
3.60 score on a scale (100 points total)
Standard Deviation 11.54
|
|
Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 5 (Week 24)
|
6.55 score on a scale (100 points total)
Standard Deviation 10.47
|
3.20 score on a scale (100 points total)
Standard Deviation 13.31
|
|
Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Follow-Up (Week 42)
|
4.80 score on a scale (100 points total)
Standard Deviation 21.81
|
2.40 score on a scale (100 points total)
Standard Deviation 12.82
|
|
Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
End of Study (Week 52)
|
12.36 score on a scale (100 points total)
Standard Deviation 17.66
|
-1.20 score on a scale (100 points total)
Standard Deviation 11.63
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Health Distress sub-scale. The score ranges from 0 to 100 percent, and is 14% of the total Mental Health Composite Score and 11% of the total Physical Health Composite Score.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 1/Baseline (Week 0)
|
54.09 score on a scale (100 points total)
Standard Deviation 24.58
|
36.00 score on a scale (100 points total)
Standard Deviation 28.07
|
|
Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 3 (Week 8)
|
19.55 score on a scale (100 points total)
Standard Deviation 25.44
|
16.50 score on a scale (100 points total)
Standard Deviation 22.12
|
|
Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 5 (Week 24)
|
13.18 score on a scale (100 points total)
Standard Deviation 25.33
|
4.50 score on a scale (100 points total)
Standard Deviation 19.36
|
|
Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Follow-Up (Week 42)
|
5.50 score on a scale (100 points total)
Standard Deviation 40.03
|
2.50 score on a scale (100 points total)
Standard Deviation 19.18
|
|
Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
End of Study (Week 52)
|
25.00 score on a scale (100 points total)
Standard Deviation 28.55
|
-2.00 score on a scale (100 points total)
Standard Deviation 13.58
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Role Limitation/Emotional sub-scale. The score ranges from 0 to 100 percent, and is 24% of the total Mental Health Composite Score.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 1/Baseline (Week 0)
|
63.64 score on a scale (100 points total)
Standard Deviation 43.35
|
73.33 score on a scale (100 points total)
Standard Deviation 43.89
|
|
Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 3 (Week 8)
|
15.15 score on a scale (100 points total)
Standard Deviation 27.34
|
3.33 score on a scale (100 points total)
Standard Deviation 65.64
|
|
Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 5 (Week 24)
|
15.15 score on a scale (100 points total)
Standard Deviation 27.34
|
0.00 score on a scale (100 points total)
Standard Deviation 41.57
|
|
Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Follow-Up (Week 42)
|
13.33 score on a scale (100 points total)
Standard Deviation 28.11
|
-10.00 score on a scale (100 points total)
Standard Deviation 66.76
|
|
Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
End of Study (Week 52)
|
18.18 score on a scale (100 points total)
Standard Deviation 31.14
|
-10.00 score on a scale (100 points total)
Standard Deviation 80.20
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Overall Quality of Life sub-scale. The score ranges from 0 to 100 percent, and is 18% of the total Mental Health Composite Score.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 1/Baseline (Week 0)
|
71.82 score on a scale (100 points total)
Standard Deviation 15.92
|
48.50 score on a scale (100 points total)
Standard Deviation 12.62
|
|
Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 3 (Week 8)
|
6.05 score on a scale (100 points total)
Standard Deviation 13.93
|
7.00 score on a scale (100 points total)
Standard Deviation 12.55
|
|
Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 5 (Week 24)
|
3.04 score on a scale (100 points total)
Standard Deviation 14.20
|
4.67 score on a scale (100 points total)
Standard Deviation 12.15
|
|
Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Follow-Up (Week 42)
|
-1.83 score on a scale (100 points total)
Standard Deviation 14.54
|
1.84 score on a scale (100 points total)
Standard Deviation 12.52
|
|
Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
End of Study (Week 52)
|
3.64 score on a scale (100 points total)
Standard Deviation 10.14
|
4.50 score on a scale (100 points total)
Standard Deviation 9.85
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Energy/Fatigue sub-scale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 1/Baseline (Week 0)
|
48.00 score on a scale (100 points total)
Standard Deviation 15.59
|
32.00 score on a scale (100 points total)
Standard Deviation 21.08
|
|
Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 3 (Week 8)
|
6.18 score on a scale (100 points total)
Standard Deviation 13.67
|
13.60 score on a scale (100 points total)
Standard Deviation 14.14
|
|
Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 5 (Week 24)
|
4.36 score on a scale (100 points total)
Standard Deviation 17.75
|
10.40 score on a scale (100 points total)
Standard Deviation 14.01
|
|
Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Follow-Up (Week 42)
|
2.00 score on a scale (100 points total)
Standard Deviation 21.44
|
2.40 score on a scale (100 points total)
Standard Deviation 17.40
|
|
Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
End of Study (Week 52)
|
15.27 score on a scale (100 points total)
Standard Deviation 20.62
|
1.60 score on a scale (100 points total)
Standard Deviation 9.47
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Health Perception sub-scale. The score ranges from 0 to 100 percent, and is 17% of the total Physical Health Composite Score.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 1/Baseline (Week 0)
|
59.55 score on a scale (100 points total)
Standard Deviation 18.09
|
42.00 score on a scale (100 points total)
Standard Deviation 21.76
|
|
Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 3 (Week 8)
|
9.09 score on a scale (100 points total)
Standard Deviation 18.68
|
5.00 score on a scale (100 points total)
Standard Deviation 9.43
|
|
Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 5 (Week 24)
|
0.00 score on a scale (100 points total)
Standard Deviation 17.03
|
3.50 score on a scale (100 points total)
Standard Deviation 15.82
|
|
Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Follow-Up (Week 42)
|
10.00 score on a scale (100 points total)
Standard Deviation 15.09
|
-1.50 score on a scale (100 points total)
Standard Deviation 12.48
|
|
Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
End of Study (Week 52)
|
12.27 score on a scale (100 points total)
Standard Deviation 19.41
|
-2.00 score on a scale (100 points total)
Standard Deviation 12.06
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Physical Function sub-scale. The score ranges from 0 to 100 percent, and is 17% of the total Physical Health Composite Score.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 1/Baseline (Week 0)
|
36.36 score on a scale (100 points total)
Standard Deviation 25.21
|
43.00 score on a scale (100 points total)
Standard Deviation 17.19
|
|
Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 3 (Week 8)
|
1.36 score on a scale (100 points total)
Standard Deviation 24.20
|
-1.50 score on a scale (100 points total)
Standard Deviation 15.28
|
|
Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 5 (Week 24)
|
12.27 score on a scale (100 points total)
Standard Deviation 10.09
|
-6.00 score on a scale (100 points total)
Standard Deviation 19.26
|
|
Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Follow-Up (Week 42)
|
7.50 score on a scale (100 points total)
Standard Deviation 13.99
|
-0.50 score on a scale (100 points total)
Standard Deviation 19.78
|
|
Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
End of Study (Week 52)
|
7.73 score on a scale (100 points total)
Standard Deviation 15.06
|
7.00 score on a scale (100 points total)
Standard Deviation 25.63
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Role Limitations - Physical sub-scale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 1/Baseline (Week 0)
|
38.64 score on a scale (100 points total)
Standard Deviation 40.87
|
20.00 score on a scale (100 points total)
Standard Deviation 32.91
|
|
Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 3 (Week 8)
|
11.36 score on a scale (100 points total)
Standard Deviation 42.37
|
22.50 score on a scale (100 points total)
Standard Deviation 38.10
|
|
Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 5 (Week 24)
|
6.82 score on a scale (100 points total)
Standard Deviation 38.88
|
17.50 score on a scale (100 points total)
Standard Deviation 35.45
|
|
Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Follow-Up (Week 42)
|
-2.50 score on a scale (100 points total)
Standard Deviation 49.23
|
5.00 score on a scale (100 points total)
Standard Deviation 15.81
|
|
Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
End of Study (Week 52)
|
34.09 score on a scale (100 points total)
Standard Deviation 45.10
|
10.00 score on a scale (100 points total)
Standard Deviation 50.28
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Pain subscale. The score ranges from 0 to 100 percent, and is 11% of the total Physical Health Composite Score.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 1/Baseline (Week 0)
|
71.82 score on a scale (100 points total)
Standard Deviation 14.38
|
59.83 score on a scale (100 points total)
Standard Deviation 27.66
|
|
Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 3 (Week 8)
|
7.12 score on a scale (100 points total)
Standard Deviation 15.19
|
7.17 score on a scale (100 points total)
Standard Deviation 17.02
|
|
Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 5 (Week 24)
|
4.55 score on a scale (100 points total)
Standard Deviation 26.28
|
4.34 score on a scale (100 points total)
Standard Deviation 16.80
|
|
Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Follow-Up (Week 42)
|
-1.50 score on a scale (100 points total)
Standard Deviation 32.12
|
0.00 score on a scale (100 points total)
Standard Deviation 14.66
|
|
Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
End of Study (Week 52)
|
13.49 score on a scale (100 points total)
Standard Deviation 18.17
|
1.33 score on a scale (100 points total)
Standard Deviation 17.65
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Social Function subscale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 1/Baseline (Week 0)
|
67.42 score on a scale (100 points total)
Standard Deviation 23.70
|
59.17 score on a scale (100 points total)
Standard Deviation 14.93
|
|
Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 3 (Week 8)
|
6.06 score on a scale (100 points total)
Standard Deviation 25.02
|
-2.50 score on a scale (100 points total)
Standard Deviation 11.15
|
|
Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 5 (Week 24)
|
5.30 score on a scale (100 points total)
Standard Deviation 13.58
|
-1.67 score on a scale (100 points total)
Standard Deviation 15.11
|
|
Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Follow-Up (Week 42)
|
2.50 score on a scale (100 points total)
Standard Deviation 23.26
|
-4.16 score on a scale (100 points total)
Standard Deviation 27.00
|
|
Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
End of Study (Week 52)
|
13.64 score on a scale (100 points total)
Standard Deviation 25.35
|
1.67 score on a scale (100 points total)
Standard Deviation 15.11
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Sexual Function subscale. The score ranges from 0 to 100 percent, and is 8% of the total Physical Health Composite Score.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 1/Baseline (Week 0)
|
65.15 score on a scale (100 points total)
Standard Deviation 30.47
|
71.67 score on a scale (100 points total)
Standard Deviation 24.60
|
|
Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 3 (Week 8)
|
8.33 score on a scale (100 points total)
Standard Deviation 25.27
|
-2.50 score on a scale (100 points total)
Standard Deviation 20.44
|
|
Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Infusion 5 (Week 24)
|
8.34 score on a scale (100 points total)
Standard Deviation 26.09
|
-3.33 score on a scale (100 points total)
Standard Deviation 20.87
|
|
Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Follow-Up (Week 42)
|
6.66 score on a scale (100 points total)
Standard Deviation 33.52
|
-3.33 score on a scale (100 points total)
Standard Deviation 14.28
|
|
Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
End of Study (Week 52)
|
9.85 score on a scale (100 points total)
Standard Deviation 19.65
|
-4.16 score on a scale (100 points total)
Standard Deviation 15.84
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
Analysis of covariance (ANCOVA) is a statistical model that combines linear regression and ANOVA to analyze the results of different treatments. In this outcome measure, ANCOVA was used to analyze change in the physical health composite score in treatment versus placebo. The ANCOVA model was used to compare HB-adMSC patients with placebo patients on Change from Baseline to Week 52 with a fixed factor of treatment, fixed stratification factors of MS severity, age and gender, and a covariate of the baseline value for the score on the corresponding outcome measure. This model allows us to test the significance of the effects of the treatment at Week 52. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54
|
19.872 score on a scale (100 points total)
Standard Error 2.979
|
-2.248 score on a scale (100 points total)
Standard Error 3.145
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
Analysis of covariance (ANCOVA) is a statistical model that combines linear regression and ANOVA to analyze the results of different treatments. In this outcome measure, ANCOVA was used to analyze change in the mental health composite score in treatment versus placebo. The ANCOVA model was used to compare HB-adMSC patients with placebo patients on Change from Baseline to Week 52 with a fixed factor of treatment, fixed stratification factors of MS severity, age and gender, and a covariate of the baseline value for the score on the corresponding outcome measure. This model allows us to test the significance of the effects of the treatment at Week 52. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 Composite Score
|
13.362 score on a scale (100 points total)
Standard Error 3.961
|
-2.402 score on a scale (100 points total)
Standard Error 4.161
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
Bayesian analysis is a statistical method that uses probability distributions to make statistical inferences about parameters using prior information. In this outcome measure, Bayesian analysis was used to analyze change in the physical health composite score in treatment versus placebo. In this study, Bayesian analysis was used to estimate the posterior distribution and to estimate the probability of the true treatment difference of change from baseline to Week 52. A linear model for each visit was constructed to model within-subject observation covariance structures by multivariate normal (MVN) distribution in the Markov chain Monte Carlo (MCMC) procedure. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54
|
18.373 score on a scale (100 points total)
Standard Deviation 5.426
|
-3.764 score on a scale (100 points total)
Standard Deviation 5.308
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.
Bayesian analysis is a statistical method that uses probability distributions to make statistical inferences about parameters using prior information. In this outcome measure, Bayesian analysis was used to analyze change in the mental health composite score in treatment versus placebo. In this study, Bayesian analysis was used to estimate the posterior distribution and to estimate the probability of the true treatment difference of change from baseline to Week 52. A linear model for each visit was constructed to model within-subject observation covariance structures by multivariate normal (MVN) distribution in the Markov chain Monte Carlo (MCMC) procedure. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline - Multiple Sclerosis Quality of Life (MSQOL)-54
|
12.414 score on a scale (100 points total)
Standard Deviation 7.457
|
-3.333 score on a scale (100 points total)
Standard Deviation 7.544
|
SECONDARY outcome
Timeframe: Baseline to Week 52The EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. This scale ranges from 0 to 10 in 0.5-unit increments and a higher score represents increased disability. Scoring is based on an examination by a neurologist.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Analysis of Covariance (ANCOVA) Model - Total Expanded Disability Status Scale (EDSS) Scores Through Week 52 - Change From Baseline - Efficacy Analysis Set
|
-1.502 score on a scale (10 points total)
Standard Error 0.424
|
0.052 score on a scale (10 points total)
Standard Error 0.446
|
SECONDARY outcome
Timeframe: Baseline to Week 52The Barthel index is an ordinal scale that evaluates functional independence in the domains of personal care and mobility. A total of ten variables describing activities of daily living and mobility are considered, with a higher number reflecting better capacity to operate independently. The Barthel Index assesses the level of help needed by a person on a set of ten activities of daily living (ADL) related to mobility and self-care. Score ranges from 0 points to 20 points, with lower scores indicating increased disability.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Analysis of Covariance (ANCOVA) Model - Change From Baseline Barthel Index Scores Through Week 52 - Efficacy Analysis Set
|
2.359 score on a scale (20 points total)
Standard Error 1.867
|
-3.094 score on a scale (20 points total)
Standard Error 1.962
|
SECONDARY outcome
Timeframe: Baseline to Week 52The 9-HPT is a short, standardized upper extremity exam. It measures the time taken to complete the test activity, recorded in seconds. The higher the score the worse the disability.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
ANCOVA Model - Change From Baseline 9-Hole Peg Test Scores - Dominant Hand Avg Time Through Week 52
|
0.472 seconds
Standard Error 3.725
|
-9.639 seconds
Standard Error 3.915
|
SECONDARY outcome
Timeframe: Baseline to Week 52The 9-HPT is a short, standardized upper extremity exam. It measures the time taken to complete the test activity, recorded in seconds. The higher the score the worse the disability.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Analysis of Covariance (ANCOVA) Model - Change From Baseline 9-Hole Peg Test Scores - Non-Dominant Hand Avg Time Through Week 52
|
-3.771 seconds
Standard Error 1.069
|
-4.747 seconds
Standard Error 1.127
|
SECONDARY outcome
Timeframe: Baseline to Week 52The PHQ-9 is the most used depression and suicidal thoughts screening test used to monitor the severity of depression and response to treatment. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Outcome measures
| Measure |
Treatment
n=11 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=10 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Analysis of Covariance (ANCOVA) Model - Change in Patient Health Questionnaire (PHQ-9) Test Scores
|
-4.330 score on a scale (27 points total)
Standard Error 0.693
|
0.263 score on a scale (27 points total)
Standard Error 0.728
|
SECONDARY outcome
Timeframe: BaselineBaseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Baseline Vitals Values - Height
|
166.17 cm
Standard Error 3.151
|
167.86 cm
Standard Error 2.626
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) .
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Vitals Values - Weight
Infusion 1 (Baseline)
|
68.61 kg
Standard Error 5.050
|
76.55 kg
Standard Error 4.797
|
|
Change From Baseline Vitals Values - Weight
Infusion 2 - Week 4
|
0.15 kg
Standard Error 0.309
|
0.18 kg
Standard Error 0.406
|
|
Change From Baseline Vitals Values - Weight
Infusion 3- Week 8
|
-0.04 kg
Standard Error 0.385
|
-0.05 kg
Standard Error 0.441
|
|
Change From Baseline Vitals Values - Weight
Infusion 4- Week 16
|
1.02 kg
Standard Error 0.972
|
-0.18 kg
Standard Error 0.727
|
|
Change From Baseline Vitals Values - Weight
Infusion 5- Week 24
|
0.56 kg
Standard Error 1.043
|
-0.56 kg
Standard Error 0.923
|
|
Change From Baseline Vitals Values - Weight
Infusion 6- Week 32
|
1.05 kg
Standard Error 1.105
|
-0.31 kg
Standard Error 1.149
|
|
Change From Baseline Vitals Values - Weight
Follow-Up- Week 42
|
1.19 kg
Standard Error 2.665
|
-0.14 kg
Standard Error 1.350
|
|
Change From Baseline Vitals Values - Weight
End of Study- Week 52
|
0.82 kg
Standard Error 1.519
|
0.03 kg
Standard Error 1.332
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) .
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Vitals Values - Body Mass Index
Infusion 1 (Baseline)
|
24.72 kg/m^2
Standard Error 1.593
|
27.17 kg/m^2
Standard Error 1.652
|
|
Change From Baseline Vitals Values - Body Mass Index
Infusion 2 - Week 4
|
0.05 kg/m^2
Standard Error 0.112
|
0.07 kg/m^2
Standard Error 0.146
|
|
Change From Baseline Vitals Values - Body Mass Index
Infusion 3 - Week 8
|
-0.00 kg/m^2
Standard Error 0.142
|
-0.04 kg/m^2
Standard Error 0.164
|
|
Change From Baseline Vitals Values - Body Mass Index
Infusion 4 - Week 16
|
0.46 kg/m^2
Standard Error 0.399
|
-0.05 kg/m^2
Standard Error 0.263
|
|
Change From Baseline Vitals Values - Body Mass Index
Infusion 5 - Week 24
|
0.28 kg/m^2
Standard Error 0.417
|
-0.19 kg/m^2
Standard Error 0.332
|
|
Change From Baseline Vitals Values - Body Mass Index
Infusion 6 - Week 32
|
0.47 kg/m^2
Standard Error 0.436
|
-0.11 kg/m^2
Standard Error 0.399
|
|
Change From Baseline Vitals Values - Body Mass Index
Follow-Up - Week 42
|
0.61 kg/m^2
Standard Error 1.014
|
-0.05 kg/m^2
Standard Error 0.476
|
|
Change From Baseline Vitals Values - Body Mass Index
End of Study - Week 52
|
0.37 kg/m^2
Standard Error 0.591
|
-0.02 kg/m^2
Standard Error 0.505
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) .
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Vitals Values - Respiratory Rate
Infusion 1 (Baseline)
|
16.7 Breaths/min
Standard Error 0.28
|
16.3 Breaths/min
Standard Error 0.22
|
|
Change From Baseline Vitals Values - Respiratory Rate
Infusion 2 - Week 4
|
0.0 Breaths/min
Standard Error 0.35
|
0.2 Breaths/min
Standard Error 0.17
|
|
Change From Baseline Vitals Values - Respiratory Rate
Infusion 3 - Week 8
|
0.0 Breaths/min
Standard Error 0.35
|
0.4 Breaths/min
Standard Error 0.24
|
|
Change From Baseline Vitals Values - Respiratory Rate
Infusion 4 - Week 16
|
0.0 Breaths/min
Standard Error 0.00
|
0.5 Breaths/min
Standard Error 0.28
|
|
Change From Baseline Vitals Values - Respiratory Rate
Infusion 5 - Week 24
|
-0.2 Breaths/min
Standard Error 0.17
|
0.6 Breaths/min
Standard Error 0.31
|
|
Change From Baseline Vitals Values - Respiratory Rate
Infusion 6 - Week 32
|
0.2 Breaths/min
Standard Error 0.17
|
0.2 Breaths/min
Standard Error 0.20
|
|
Change From Baseline Vitals Values - Respiratory Rate
Follow-Up - Week 42
|
0.4 Breaths/min
Standard Error 0.24
|
0.6 Breaths/min
Standard Error 0.31
|
|
Change From Baseline Vitals Values - Respiratory Rate
End of Study - Week 52
|
0.2 Breaths/min
Standard Error 0.33
|
0.6 Breaths/min
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) .
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Vitals Values - Temperature
Infusion 1 (Baseline)
|
36.66 degrees Celsius
Standard Error 0.073
|
36.84 degrees Celsius
Standard Error 0.080
|
|
Change From Baseline Vitals Values - Temperature
Infusion 2 - Week 4
|
-0.01 degrees Celsius
Standard Error 0.083
|
-0.23 degrees Celsius
Standard Error 0.070
|
|
Change From Baseline Vitals Values - Temperature
Infusion 3 - Week 8
|
0.03 degrees Celsius
Standard Error 0.095
|
-0.21 degrees Celsius
Standard Error 0.108
|
|
Change From Baseline Vitals Values - Temperature
Infusion 4 - Week 16
|
-0.03 degrees Celsius
Standard Error 0.074
|
-0.06 degrees Celsius
Standard Error 0.095
|
|
Change From Baseline Vitals Values - Temperature
Infusion 5 - Week 24
|
0.04 degrees Celsius
Standard Error 0.084
|
-0.17 degrees Celsius
Standard Error 0.115
|
|
Change From Baseline Vitals Values - Temperature
Infusion 6 - Week 32
|
-0.08 degrees Celsius
Standard Error 0.102
|
-0.18 degrees Celsius
Standard Error 0.101
|
|
Change From Baseline Vitals Values - Temperature
Follow-Up - Week 42
|
-0.10 degrees Celsius
Standard Error 0.077
|
-0.15 degrees Celsius
Standard Error 0.092
|
|
Change From Baseline Vitals Values - Temperature
End of Study - Week 52
|
-0.02 degrees Celsius
Standard Error 0.088
|
-0.11 degrees Celsius
Standard Error 0.132
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) .
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Vitals Values - Systolic Blood Pressure
Infusion 1 (Baseline)
|
119.2 mmHg
Standard Error 2.90
|
122.2 mmHg
Standard Error 3.72
|
|
Change From Baseline Vitals Values - Systolic Blood Pressure
Infusion 2 - Week 4
|
6.3 mmHg
Standard Error 3.10
|
0.8 mmHg
Standard Error 2.74
|
|
Change From Baseline Vitals Values - Systolic Blood Pressure
Infusion 3 - Week 8
|
-5.0 mmHg
Standard Error 2.11
|
-2.8 mmHg
Standard Error 3.62
|
|
Change From Baseline Vitals Values - Systolic Blood Pressure
Infusion 4 - Week 16
|
1.5 mmHg
Standard Error 3.27
|
5.4 mmHg
Standard Error 3.25
|
|
Change From Baseline Vitals Values - Systolic Blood Pressure
Infusion 5 - Week 24
|
-3.5 mmHg
Standard Error 3.18
|
-0.6 mmHg
Standard Error 2.77
|
|
Change From Baseline Vitals Values - Systolic Blood Pressure
Infusion 6 - Week 32
|
4.3 mmHg
Standard Error 3.87
|
1.5 mmHg
Standard Error 3.37
|
|
Change From Baseline Vitals Values - Systolic Blood Pressure
Follow-Up - Week 42
|
-4.0 mmHg
Standard Error 3.83
|
-1.1 mmHg
Standard Error 2.52
|
|
Change From Baseline Vitals Values - Systolic Blood Pressure
End of Study - Week 52
|
1.4 mmHg
Standard Error 4.43
|
0.7 mmHg
Standard Error 4.26
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) .
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Vitals Values - Diastolic Blood Pressure
Infusion 1 (Baseline)
|
76.3 mmHg
Standard Error 1.90
|
78.9 mmHg
Standard Error 1.53
|
|
Change From Baseline Vitals Values - Diastolic Blood Pressure
Infusion 2 - Week 4
|
2.5 mmHg
Standard Error 2.00
|
1.1 mmHg
Standard Error 1.91
|
|
Change From Baseline Vitals Values - Diastolic Blood Pressure
Infusion 3 - Week 8
|
-1.3 mmHg
Standard Error 1.97
|
0.0 mmHg
Standard Error 2.23
|
|
Change From Baseline Vitals Values - Diastolic Blood Pressure
Infusion 4 - Week 16
|
0.9 mmHg
Standard Error 2.66
|
2.4 mmHg
Standard Error 2.21
|
|
Change From Baseline Vitals Values - Diastolic Blood Pressure
Infusion 5 - Week 24
|
-3.2 mmHg
Standard Error 2.17
|
1.4 mmHg
Standard Error 1.97
|
|
Change From Baseline Vitals Values - Diastolic Blood Pressure
Infusion 6 - Week 32
|
4.0 mmHg
Standard Error 1.85
|
2.6 mmHg
Standard Error 2.93
|
|
Change From Baseline Vitals Values - Diastolic Blood Pressure
Follow-Up - Week 42
|
-1.6 mmHg
Standard Error 2.76
|
3.6 mmHg
Standard Error 3.11
|
|
Change From Baseline Vitals Values - Diastolic Blood Pressure
End of Study - Week 52
|
-1.1 mmHg
Standard Error 2.27
|
3.3 mmHg
Standard Error 2.12
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) .
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Vitals Values - Pulse Rate
Infusion 1 (Baseline)
|
71.8 beats per minute
Standard Error 3.16
|
76.2 beats per minute
Standard Error 1.66
|
|
Change From Baseline Vitals Values - Pulse Rate
Infusion 2 - Week 4
|
0.4 beats per minute
Standard Error 2.60
|
-0.9 beats per minute
Standard Error 2.00
|
|
Change From Baseline Vitals Values - Pulse Rate
Infusion 3 - Week 8
|
3.3 beats per minute
Standard Error 3.40
|
2.4 beats per minute
Standard Error 2.57
|
|
Change From Baseline Vitals Values - Pulse Rate
Infusion 4 - Week 16
|
0.3 beats per minute
Standard Error 3.70
|
2.0 beats per minute
Standard Error 2.38
|
|
Change From Baseline Vitals Values - Pulse Rate
Infusion 5 - Week 24
|
-2.6 beats per minute
Standard Error 2.71
|
-1.1 beats per minute
Standard Error 2.22
|
|
Change From Baseline Vitals Values - Pulse Rate
Infusion 6 - Week 32
|
1.9 beats per minute
Standard Error 4.30
|
-2.1 beats per minute
Standard Error 2.25
|
|
Change From Baseline Vitals Values - Pulse Rate
Follow-Up - Week 42
|
1.2 beats per minute
Standard Error 3.30
|
-4.0 beats per minute
Standard Error 2.56
|
|
Change From Baseline Vitals Values - Pulse Rate
End of Study - Week 52
|
-4.1 beats per minute
Standard Error 2.48
|
-1.2 beats per minute
Standard Error 3.21
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) .
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Vitals Values - Oxygen Saturation
Infusion 1 (Baseline)
|
98.4 percent of oxygen
Standard Error 0.23
|
98.0 percent of oxygen
Standard Error 0.35
|
|
Change From Baseline Vitals Values - Oxygen Saturation
Infusion 2 - Week 4
|
-0.7 percent of oxygen
Standard Error 0.40
|
0.6 percent of oxygen
Standard Error 0.38
|
|
Change From Baseline Vitals Values - Oxygen Saturation
Infusion 3 - Week 8
|
-0.4 percent of oxygen
Standard Error 0.38
|
0.5 percent of oxygen
Standard Error 0.45
|
|
Change From Baseline Vitals Values - Oxygen Saturation
Infusion 4 - Week 16
|
-0.4 percent of oxygen
Standard Error 0.34
|
0.3 percent of oxygen
Standard Error 0.47
|
|
Change From Baseline Vitals Values - Oxygen Saturation
Infusion 5 - Week 24
|
0.0 percent of oxygen
Standard Error 0.30
|
-0.4 percent of oxygen
Standard Error 0.31
|
|
Change From Baseline Vitals Values - Oxygen Saturation
Infusion 6 - Week 32
|
-0.9 percent of oxygen
Standard Error 0.54
|
0.3 percent of oxygen
Standard Error 0.47
|
|
Change From Baseline Vitals Values - Oxygen Saturation
Follow-Up - Week 42
|
-0.4 percent of oxygen
Standard Error 0.28
|
-0.5 percent of oxygen
Standard Error 0.64
|
|
Change From Baseline Vitals Values - Oxygen Saturation
End of Study - Week 52
|
-0.5 percent of oxygen
Standard Error 0.45
|
0.4 percent of oxygen
Standard Error 0.54
|
SECONDARY outcome
Timeframe: Baseline to Week 52Change From Baseline Physical Examination Results by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 1 (Baseline) · Normal
|
12 Participants
|
12 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 1 (Baseline) · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 1 (Baseline) · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 2 - Week 4 · Normal
|
12 Participants
|
12 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 2 - Week 4 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 2 - Week 4 · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 3 - Week 8 · Normal
|
12 Participants
|
11 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 3 - Week 8 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 3 - Week 8 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 4 - Week 16 · Normal
|
12 Participants
|
11 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 4 - Week 16 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 4 - Week 16 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 5 - Week 24 · Normal
|
12 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 5 - Week 24 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 5 - Week 24 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 6 - Week 32 · Normal
|
12 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 6 - Week 32 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Infusion 6 - Week 32 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Follow-Up - Week 42 · Normal
|
11 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Follow-Up - Week 42 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
Follow-Up - Week 42 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
End of Study - Week 52 · Normal
|
11 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
End of Study - Week 52 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Abdomen
End of Study - Week 52 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 6 - Week 32 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 1 (Baseline) · Normal
|
12 Participants
|
12 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 1 (Baseline) · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 1 (Baseline) · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 2 - Week 4 · Normal
|
12 Participants
|
12 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 2 - Week 4 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 2 - Week 4 · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 3 - Week 8 · Normal
|
12 Participants
|
11 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 3 - Week 8 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 3 - Week 8 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 4 - Week 16 · Normal
|
12 Participants
|
11 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 4 - Week 16 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 4 - Week 16 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 5 - Week 24 · Normal
|
12 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 5 - Week 24 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 5 - Week 24 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 6 - Week 32 · Normal
|
12 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Infusion 6 - Week 32 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Follow-Up - Week 42 · Normal
|
11 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Follow-Up - Week 42 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
Follow-Up - Week 42 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
End of Study - Week 52 · Normal
|
11 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
End of Study - Week 52 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Cardiovascular
End of Study - Week 52 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 1 (Baseline) · Normal
|
12 Participants
|
12 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 1 (Baseline) · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 1 (Baseline) · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 2 - Week 4 · Normal
|
12 Participants
|
12 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 2 - Week 4 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 2 - Week 4 · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 3 - Week 8 · Normal
|
12 Participants
|
11 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 3 - Week 8 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 3 - Week 8 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 4 - Week 16 · Normal
|
12 Participants
|
11 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 4 - Week 16 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 4 - Week 16 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 5 - Week 24 · Normal
|
12 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 5 - Week 24 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 5 - Week 24 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 6 - Week 32 · Normal
|
12 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 6 - Week 32 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Infusion 6 - Week 32 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Follow-Up - Week 42 · Normal
|
11 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Follow-Up - Week 42 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
Follow-Up - Week 42 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
End of Study - Week 52 · Normal
|
11 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
End of Study - Week 52 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - HEENT
End of Study - Week 52 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 6 - Week 32 · Normal
|
12 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 1 (Baseline) · Normal
|
12 Participants
|
12 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 1 (Baseline) · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 1 (Baseline) · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 2 - Week 4 · Normal
|
12 Participants
|
12 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 2 - Week 4 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 2 - Week 4 · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 3 - Week 8 · Normal
|
12 Participants
|
11 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 3 - Week 8 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 3 - Week 8 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 4 - Week 16 · Normal
|
12 Participants
|
11 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 4 - Week 16 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 4 - Week 16 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 5 - Week 24 · Normal
|
12 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 5 - Week 24 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 5 - Week 24 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 6 - Week 32 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Infusion 6 - Week 32 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Follow-Up - Week 42 · Normal
|
11 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Follow-Up - Week 42 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
Follow-Up - Week 42 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
End of Study - Week 52 · Normal
|
11 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
End of Study - Week 52 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Lymph Node
End of Study - Week 52 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 1 (Baseline) · Normal
|
6 Participants
|
3 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 1 (Baseline) · Abnormal
|
6 Participants
|
9 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 1 (Baseline) · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 2 - Week 4 · Normal
|
7 Participants
|
4 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 2 - Week 4 · Abnormal
|
5 Participants
|
8 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 2 - Week 4 · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 3 - Week 8 · Normal
|
5 Participants
|
3 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 3 - Week 8 · Abnormal
|
7 Participants
|
8 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 3 - Week 8 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 4 - Week 16 · Normal
|
5 Participants
|
4 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 4 - Week 16 · Abnormal
|
7 Participants
|
7 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 4 - Week 16 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 5 - Week 24 · Normal
|
4 Participants
|
4 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 5 - Week 24 · Abnormal
|
8 Participants
|
6 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 5 - Week 24 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 6 - Week 32 · Normal
|
4 Participants
|
4 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 6 - Week 32 · Abnormal
|
8 Participants
|
6 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Infusion 6 - Week 32 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Follow-Up - Week 42 · Normal
|
2 Participants
|
4 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Follow-Up - Week 42 · Abnormal
|
9 Participants
|
6 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
Follow-Up - Week 42 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
End of Study - Week 52 · Normal
|
3 Participants
|
4 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
End of Study - Week 52 · Abnormal
|
8 Participants
|
6 Participants
|
|
Change From Baseline Physical Examination Results - Musculoskeletal
End of Study - Week 52 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 4 - Week 16 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 5 - Week 24 · Normal
|
1 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 5 - Week 24 · Abnormal
|
11 Participants
|
9 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 5 - Week 24 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 6 - Week 32 · Normal
|
2 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 6 - Week 32 · Abnormal
|
10 Participants
|
8 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 6 - Week 32 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Follow-Up - Week 42 · Normal
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Follow-Up - Week 42 · Abnormal
|
11 Participants
|
9 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Follow-Up - Week 42 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
End of Study - Week 52 · Normal
|
2 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
End of Study - Week 52 · Abnormal
|
9 Participants
|
8 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
End of Study - Week 52 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 1 (Baseline) · Normal
|
2 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 1 (Baseline) · Abnormal
|
10 Participants
|
11 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 1 (Baseline) · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 2 - Week 4 · Normal
|
3 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 2 - Week 4 · Abnormal
|
9 Participants
|
11 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 2 - Week 4 · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 3 - Week 8 · Normal
|
1 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 3 - Week 8 · Abnormal
|
11 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 3 - Week 8 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 4 - Week 16 · Normal
|
1 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Neurological
Infusion 4 - Week 16 · Abnormal
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 1 (Baseline) · Normal
|
12 Participants
|
12 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 1 (Baseline) · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 1 (Baseline) · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 2 - Week 4 · Normal
|
12 Participants
|
12 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 2 - Week 4 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 2 - Week 4 · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 3 - Week 8 · Normal
|
12 Participants
|
11 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 3 - Week 8 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 3 - Week 8 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 4 - Week 16 · Normal
|
12 Participants
|
11 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 4 - Week 16 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 4 - Week 16 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 5 - Week 24 · Normal
|
12 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 5 - Week 24 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 5 - Week 24 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 6 - Week 32 · Normal
|
12 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 6 - Week 32 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Infusion 6 - Week 32 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Follow-Up - Week 42 · Normal
|
11 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Follow-Up - Week 42 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
Follow-Up - Week 42 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
End of Study - Week 52 · Normal
|
11 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
End of Study - Week 52 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Respiratory
End of Study - Week 52 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Change From Baseline Physical Examination Results - Skin
Infusion 1 (Baseline) · Normal
|
11 Participants
|
12 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 1 (Baseline) · Abnormal
|
1 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 1 (Baseline) · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 2 - Week 4 · Normal
|
12 Participants
|
12 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 2 - Week 4 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 2 - Week 4 · Not Examined (No longer in Study)
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 3 - Week 8 · Normal
|
11 Participants
|
11 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 3 - Week 8 · Abnormal
|
1 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 3 - Week 8 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 4 - Week 16 · Normal
|
12 Participants
|
11 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 4 - Week 16 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 4 - Week 16 · Not Examined (No longer in Study)
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 5 - Week 24 · Normal
|
12 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 5 - Week 24 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 5 - Week 24 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 6 - Week 32 · Normal
|
12 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 6 - Week 32 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Infusion 6 - Week 32 · Not Examined (No longer in Study)
|
0 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Follow-Up - Week 42 · Normal
|
11 Participants
|
9 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Follow-Up - Week 42 · Abnormal
|
0 Participants
|
1 Participants
|
|
Change From Baseline Physical Examination Results - Skin
Follow-Up - Week 42 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
|
Change From Baseline Physical Examination Results - Skin
End of Study - Week 52 · Normal
|
11 Participants
|
10 Participants
|
|
Change From Baseline Physical Examination Results - Skin
End of Study - Week 52 · Abnormal
|
0 Participants
|
0 Participants
|
|
Change From Baseline Physical Examination Results - Skin
End of Study - Week 52 · Not Examined (No longer in Study)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Unit (x10\^3 cells/uL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Absolute Basophils - Baseline
|
0.027 (x10^3 cells/uL)
Standard Error 0.0048
|
0.030 (x10^3 cells/uL)
Standard Error 0.0051
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Absolute Basophils - Week 24
|
0.008 (x10^3 cells/uL)
Standard Error 0.0063
|
0.003 (x10^3 cells/uL)
Standard Error 0.0050
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Absolute Basophils - Week 52
|
0.008 (x10^3 cells/uL)
Standard Error 0.0064
|
-0.001 (x10^3 cells/uL)
Standard Error 0.0053
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Absolute Eosinophils - Baseline
|
0.107 (x10^3 cells/uL)
Standard Error 0.0267
|
0.113 (x10^3 cells/uL)
Standard Error 0.0221
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Absolute Eosinophils - Week 24
|
-0.001 (x10^3 cells/uL)
Standard Error 0.0172
|
0.018 (x10^3 cells/uL)
Standard Error 0.0156
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Absolute Eosinophils - Week 52
|
0.027 (x10^3 cells/uL)
Standard Error 0.0302
|
0.012 (x10^3 cells/uL)
Standard Error 0.0150
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Absolute Lymphocytes - Baseline
|
1.345 (x10^3 cells/uL)
Standard Error 0.0956
|
1.220 (x10^3 cells/uL)
Standard Error 0.1370
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Absolute Lymphocytes - Week 24
|
0.098 (x10^3 cells/uL)
Standard Error 0.1275
|
0.061 (x10^3 cells/uL)
Standard Error 0.0631
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Absolute Lymphocytes - Week 52
|
0.155 (x10^3 cells/uL)
Standard Error 0.1179
|
0.072 (x10^3 cells/uL)
Standard Error 0.0797
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Absolute Monocytes - Baseline
|
0.501 (x10^3 cells/uL)
Standard Error 0.0536
|
0.494 (x10^3 cells/uL)
Standard Error 0.0549
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Absolute Monocytes - Week 24
|
-0.030 (x10^3 cells/uL)
Standard Error 0.0479
|
-0.008 (x10^3 cells/uL)
Standard Error 0.0296
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Absolute Monocytes - Week 52
|
0.069 (x10^3 cells/uL)
Standard Error 0.0543
|
0.009 (x10^3 cells/uL)
Standard Error 0.0307
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Absolute Neutrophils - Baseline
|
3.348 (x10^3 cells/uL)
Standard Error 0.4070
|
3.872 (x10^3 cells/uL)
Standard Error 0.4055
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Absolute Neutrophils - Week 24
|
0.470 (x10^3 cells/uL)
Standard Error 0.4303
|
-0.066 (x10^3 cells/uL)
Standard Error 0.5305
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Absolute Neutrophils - Week 52
|
0.681 (x10^3 cells/uL)
Standard Error 0.5759
|
0.201 (x10^3 cells/uL)
Standard Error 0.5813
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Platelet Count - Baseline
|
260.6 (x10^3 cells/uL)
Standard Error 20.61
|
227.1 (x10^3 cells/uL)
Standard Error 20.28
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Platelet Count - Week 24
|
1.1 (x10^3 cells/uL)
Standard Error 8.64
|
11.1 (x10^3 cells/uL)
Standard Error 11.83
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
Platelet Count - Week 52
|
19.9 (x10^3 cells/uL)
Standard Error 8.45
|
9.5 (x10^3 cells/uL)
Standard Error 7.81
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
WBC - Baseline
|
5.35 (x10^3 cells/uL)
Standard Error 0.447
|
5.75 (x10^3 cells/uL)
Standard Error 0.504
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
WBC - Week 24
|
0.54 (x10^3 cells/uL)
Standard Error 0.450
|
0.01 (x10^3 cells/uL)
Standard Error 0.512
|
|
Laboratory Values - CBC (x10^3 Cells/uL)
WBC - Week 52
|
0.95 (x10^3 cells/uL)
Standard Error 0.577
|
0.30 (x10^3 cells/uL)
Standard Error 0.537
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in CBC laboratory values with unit of % of white blood cell count.
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - CBC (% of WBC)
Lymphocytes - Week 52
|
-3.46 % of white blood cell count
Standard Error 2.907
|
1.77 % of white blood cell count
Standard Error 4.329
|
|
Laboratory Values - CBC (% of WBC)
Monocytes - Baseline
|
8.59 % of white blood cell count
Standard Error 1.046
|
9.10 % of white blood cell count
Standard Error 1.215
|
|
Laboratory Values - CBC (% of WBC)
Basophils - Baseline
|
0.40 % of white blood cell count
Standard Error 0.161
|
0.74 % of white blood cell count
Standard Error 0.192
|
|
Laboratory Values - CBC (% of WBC)
Basophils - Week 24
|
0.22 % of white blood cell count
Standard Error 0.292
|
0.09 % of white blood cell count
Standard Error 0.308
|
|
Laboratory Values - CBC (% of WBC)
Basophils - Week 52
|
0.03 % of white blood cell count
Standard Error 0.259
|
-0.13 % of white blood cell count
Standard Error 0.256
|
|
Laboratory Values - CBC (% of WBC)
Eosinophils - Baseline
|
1.86 % of white blood cell count
Standard Error 0.552
|
2.02 % of white blood cell count
Standard Error 0.409
|
|
Laboratory Values - CBC (% of WBC)
Eosinophils - Week 24
|
0.18 % of white blood cell count
Standard Error 0.656
|
1.06 % of white blood cell count
Standard Error 0.861
|
|
Laboratory Values - CBC (% of WBC)
Eosinophils - Week 52
|
-0.01 % of white blood cell count
Standard Error 0.591
|
0.42 % of white blood cell count
Standard Error 0.373
|
|
Laboratory Values - CBC (% of WBC)
Lymphocytes - Baseline
|
27.98 % of white blood cell count
Standard Error 3.068
|
24.41 % of white blood cell count
Standard Error 2.049
|
|
Laboratory Values - CBC (% of WBC)
Lymphocytes - Week 24
|
1.58 % of white blood cell count
Standard Error 2.945
|
1.21 % of white blood cell count
Standard Error 3.152
|
|
Laboratory Values - CBC (% of WBC)
Monocytes - Week 24
|
-0.15 % of white blood cell count
Standard Error 1.124
|
-0.76 % of white blood cell count
Standard Error 1.735
|
|
Laboratory Values - CBC (% of WBC)
Monocytes - Week 52
|
1.83 % of white blood cell count
Standard Error 1.166
|
-0.02 % of white blood cell count
Standard Error 1.564
|
|
Laboratory Values - CBC (% of WBC)
Neutrophils - Baseline
|
61.17 % of white blood cell count
Standard Error 2.777
|
63.73 % of white blood cell count
Standard Error 2.516
|
|
Laboratory Values - CBC (% of WBC)
Neutrophils - Week 24
|
-2.06 % of white blood cell count
Standard Error 3.201
|
-1.68 % of white blood cell count
Standard Error 4.138
|
|
Laboratory Values - CBC (% of WBC)
Neutrophils - Week 52
|
1.38 % of white blood cell count
Standard Error 3.861
|
-2.21 % of white blood cell count
Standard Error 5.063
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in CBC laboratory values with unit of % of total blood cell count.
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - CBC (% of Total Blood Cell Count)
Hematocrit - Baseline
|
39.80 % of total blood cell count
Standard Error 0.736
|
40.77 % of total blood cell count
Standard Error 1.111
|
|
Laboratory Values - CBC (% of Total Blood Cell Count)
Hematocrit - Week 24
|
-0.48 % of total blood cell count
Standard Error 1.064
|
1.43 % of total blood cell count
Standard Error 1.392
|
|
Laboratory Values - CBC (% of Total Blood Cell Count)
Hematocrit- Week 52
|
1.02 % of total blood cell count
Standard Error 0.562
|
2.51 % of total blood cell count
Standard Error 1.116
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in CBC laboratory values with unit of g/dL
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - CBC (g/dL)
Hemoglobin - Baseline
|
13.60 g/dL
Standard Error 0.301
|
13.68 g/dL
Standard Error 0.410
|
|
Laboratory Values - CBC (g/dL)
Hemoglobin - Week 24
|
-0.18 g/dL
Standard Error 0.281
|
0.61 g/dL
Standard Error 0.498
|
|
Laboratory Values - CBC (g/dL)
Hemoglobin- Week 52
|
0.21 g/dL
Standard Error 0.168
|
0.81 g/dL
Standard Error 0.401
|
|
Laboratory Values - CBC (g/dL)
MCHC - Baseline
|
34.13 g/dL
Standard Error 0.233
|
33.53 g/dL
Standard Error 0.233
|
|
Laboratory Values - CBC (g/dL)
MCHC - Week 24
|
-0.01 g/dL
Standard Error 0.340
|
0.31 g/dL
Standard Error 0.312
|
|
Laboratory Values - CBC (g/dL)
MCHC- Week 52
|
-0.31 g/dL
Standard Error 0.236
|
-0.06 g/dL
Standard Error 0.352
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in CBC laboratory values with unit of pg
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - CBC (pg)
MCH - Baseline
|
31.20 pg
Standard Error 0.542
|
30.38 pg
Standard Error 0.471
|
|
Laboratory Values - CBC (pg)
MCH - Week 24
|
-0.23 pg
Standard Error 0.371
|
0.50 pg
Standard Error 0.286
|
|
Laboratory Values - CBC (pg)
MCH- Week 52
|
-0.25 pg
Standard Error 0.276
|
0.44 pg
Standard Error 0.465
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in CBC laboratory values with unit of fL.
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - CBC (fL)
MCV - Baseline
|
91.36 fL
Standard Error 1.332
|
90.59 fL
Standard Error 1.163
|
|
Laboratory Values - CBC (fL)
MCV - Week 24
|
-0.60 fL
Standard Error 0.937
|
0.65 fL
Standard Error 0.447
|
|
Laboratory Values - CBC (fL)
MCV - Week 52
|
0.15 fL
Standard Error 0.900
|
1.32 fL
Standard Error 0.857
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in CBC laboratory values with unit of x10\^6 cells/uL.
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - CBC (x10^6 Cells/uL)
RBC - Baseline
|
4.362 x10^6 cells/uL
Standard Error 0.0772
|
4.507 x10^6 cells/uL
Standard Error 0.1293
|
|
Laboratory Values - CBC (x10^6 Cells/uL)
RBC - Week 24
|
-0.027 x10^6 cells/uL
Standard Error 0.1130
|
0.134 x10^6 cells/uL
Standard Error 0.1769
|
|
Laboratory Values - CBC (x10^6 Cells/uL)
RBC - Week 52
|
0.100 x10^6 cells/uL
Standard Error 0.0645
|
0.222 x10^6 cells/uL
Standard Error 0.1571
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in CBC laboratory values with unit of % (RDW - Red Cell Distribution Width)
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - CBC (RDW)
RDW - Baseline
|
12.51 percentage
Standard Error 0.337
|
12.82 percentage
Standard Error 0.162
|
|
Laboratory Values - CBC (RDW)
RDW - Week 24
|
0.21 percentage
Standard Error 0.155
|
0.57 percentage
Standard Error 0.585
|
|
Laboratory Values - CBC (RDW)
RDW - Week 52
|
0.07 percentage
Standard Error 0.141
|
0.35 percentage
Standard Error 0.582
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in CMP laboratory values with unit of g/dL.
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - CMP (g/dL)
Albumin - Baseline
|
4.70 g/dL
Standard Error 0.089
|
4.64 g/dL
Standard Error 0.071
|
|
Laboratory Values - CMP (g/dL)
Albumin - Week 24
|
-0.03 g/dL
Standard Error 0.093
|
-0.03 g/dL
Standard Error 0.122
|
|
Laboratory Values - CMP (g/dL)
Albumin - Week 52
|
0.00 g/dL
Standard Error 0.086
|
-0.03 g/dL
Standard Error 0.091
|
|
Laboratory Values - CMP (g/dL)
Calc Globulin - Baseline
|
2.53 g/dL
Standard Error 0.100
|
2.10 g/dL
Standard Error 0.072
|
|
Laboratory Values - CMP (g/dL)
Calc Globulin - Week 24
|
-0.14 g/dL
Standard Error 0.075
|
-0.06 g/dL
Standard Error 0.072
|
|
Laboratory Values - CMP (g/dL)
Calc Globulin - Week 52
|
-0.14 g/dL
Standard Error 0.059
|
-0.05 g/dL
Standard Error 0.064
|
|
Laboratory Values - CMP (g/dL)
Protein - Baseline
|
7.23 g/dL
Standard Error 0.120
|
6.74 g/dL
Standard Error 0.100
|
|
Laboratory Values - CMP (g/dL)
Protein - Week 24
|
-0.17 g/dL
Standard Error 0.140
|
-0.09 g/dL
Standard Error 0.146
|
|
Laboratory Values - CMP (g/dL)
Protein - Week 52
|
-0.14 g/dL
Standard Error 0.106
|
-0.08 g/dL
Standard Error 0.085
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL)
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))
Calc A/G - Baseline
|
1.89 Ratio: Albumin(g/dL) to Globulin(g/dL
Standard Error 0.086
|
2.23 Ratio: Albumin(g/dL) to Globulin(g/dL
Standard Error 0.086
|
|
Laboratory Values - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))
Calc A/G - Week 24
|
0.10 Ratio: Albumin(g/dL) to Globulin(g/dL
Standard Error 0.066
|
0.08 Ratio: Albumin(g/dL) to Globulin(g/dL
Standard Error 0.100
|
|
Laboratory Values - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))
Calc A/G - Week 52
|
0.11 Ratio: Albumin(g/dL) to Globulin(g/dL
Standard Error 0.076
|
0.04 Ratio: Albumin(g/dL) to Globulin(g/dL
Standard Error 0.090
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in CMP laboratory values with units of U/L.
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - CMP (U/L)
Alkaline Phosphatase - Baseline
|
77.5 U/L
Standard Error 9.35
|
69.0 U/L
Standard Error 4.11
|
|
Laboratory Values - CMP (U/L)
Alkaline Phosphatase - Week 24
|
-2.6 U/L
Standard Error 4.67
|
-0.3 U/L
Standard Error 2.48
|
|
Laboratory Values - CMP (U/L)
Alkaline Phosphatase - Week 52
|
5.5 U/L
Standard Error 4.75
|
1.0 U/L
Standard Error 1.93
|
|
Laboratory Values - CMP (U/L)
ALT - Baseline
|
23.9 U/L
Standard Error 2.66
|
17.7 U/L
Standard Error 1.05
|
|
Laboratory Values - CMP (U/L)
ALT - Week 24
|
-1.4 U/L
Standard Error 1.94
|
2.9 U/L
Standard Error 1.97
|
|
Laboratory Values - CMP (U/L)
ALT - Week 52
|
1.9 U/L
Standard Error 4.03
|
-0.1 U/L
Standard Error 1.51
|
|
Laboratory Values - CMP (U/L)
AST - Baseline
|
25.7 U/L
Standard Error 2.56
|
18.3 U/L
Standard Error 1.50
|
|
Laboratory Values - CMP (U/L)
AST - Week 24
|
-3.1 U/L
Standard Error 2.07
|
2.1 U/L
Standard Error 1.92
|
|
Laboratory Values - CMP (U/L)
AST - Week 52
|
-2.8 U/L
Standard Error 2.91
|
-0.8 U/L
Standard Error 1.10
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in CMP laboratory values with units of mg/dL.
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - CMP (mg/dL)
Bilirubin - Baseline
|
0.41 mg/dL
Standard Error 0.045
|
0.44 mg/dL
Standard Error 0.051
|
|
Laboratory Values - CMP (mg/dL)
Bilirubin - Week 24
|
0.01 mg/dL
Standard Error 0.060
|
0.15 mg/dL
Standard Error 0.062
|
|
Laboratory Values - CMP (mg/dL)
Bilirubin - Week 52
|
-0.02 mg/dL
Standard Error 0.038
|
0.09 mg/dL
Standard Error 0.062
|
|
Laboratory Values - CMP (mg/dL)
Calcium - Baseline
|
9.78 mg/dL
Standard Error 0.099
|
9.51 mg/dL
Standard Error 0.108
|
|
Laboratory Values - CMP (mg/dL)
Calcium - Week 24
|
-0.20 mg/dL
Standard Error 0.145
|
-0.15 mg/dL
Standard Error 0.134
|
|
Laboratory Values - CMP (mg/dL)
Calcium - Week 52
|
-0.11 mg/dL
Standard Error 0.110
|
-0.03 mg/dL
Standard Error 0.128
|
|
Laboratory Values - CMP (mg/dL)
Creatinine - Baseline
|
0.756 mg/dL
Standard Error 0.0453
|
0.827 mg/dL
Standard Error 0.0472
|
|
Laboratory Values - CMP (mg/dL)
Creatinine - Week 24
|
0.008 mg/dL
Standard Error 0.0288
|
-0.000 mg/dL
Standard Error 0.0278
|
|
Laboratory Values - CMP (mg/dL)
Creatinine - Week 52
|
-0.001 mg/dL
Standard Error 0.0262
|
0.024 mg/dL
Standard Error 0.0348
|
|
Laboratory Values - CMP (mg/dL)
BUN - Baseline
|
14.3 mg/dL
Standard Error 1.31
|
13.4 mg/dL
Standard Error 1.20
|
|
Laboratory Values - CMP (mg/dL)
BUN - Week 24
|
-0.5 mg/dL
Standard Error 1.05
|
0.6 mg/dL
Standard Error 1.25
|
|
Laboratory Values - CMP (mg/dL)
BUN - Week 52
|
1.5 mg/dL
Standard Error 0.86
|
-0.1 mg/dL
Standard Error 1.09
|
|
Laboratory Values - CMP (mg/dL)
Glucose - Baseline
|
95.3 mg/dL
Standard Error 3.58
|
94.1 mg/dL
Standard Error 2.04
|
|
Laboratory Values - CMP (mg/dL)
Glucose - Week 24
|
-1.9 mg/dL
Standard Error 3.45
|
-3.6 mg/dL
Standard Error 3.77
|
|
Laboratory Values - CMP (mg/dL)
Glucose - Week 52
|
2.5 mg/dL
Standard Error 1.83
|
-1.6 mg/dL
Standard Error 3.81
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in CMP laboratory values with units of mEq/L.
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - CMP (mEq/L)
Chloride - Baseline
|
103.5 mEq/L
Standard Error 0.97
|
103.7 mEq/L
Standard Error 0.81
|
|
Laboratory Values - CMP (mEq/L)
Chloride - Week 24
|
-0.3 mEq/L
Standard Error 0.71
|
1.4 mEq/L
Standard Error 0.83
|
|
Laboratory Values - CMP (mEq/L)
Chloride - Week 52
|
0.2 mEq/L
Standard Error 0.64
|
0.8 mEq/L
Standard Error 1.10
|
|
Laboratory Values - CMP (mEq/L)
Carbon Dioxide - Baseline
|
25.2 mEq/L
Standard Error 0.76
|
24.7 mEq/L
Standard Error 0.63
|
|
Laboratory Values - CMP (mEq/L)
Carbon Dioxide - Week 24
|
0.1 mEq/L
Standard Error 0.58
|
0.1 mEq/L
Standard Error 0.72
|
|
Laboratory Values - CMP (mEq/L)
Carbon Dioxide - Week 52
|
0.5 mEq/L
Standard Error 0.39
|
0.1 mEq/L
Standard Error 0.86
|
|
Laboratory Values - CMP (mEq/L)
Potassium - Baseline
|
4.47 mEq/L
Standard Error 0.128
|
4.31 mEq/L
Standard Error 0.061
|
|
Laboratory Values - CMP (mEq/L)
Potassium - Week 24
|
-0.22 mEq/L
Standard Error 0.135
|
-0.13 mEq/L
Standard Error 0.060
|
|
Laboratory Values - CMP (mEq/L)
Potassium - Week 52
|
-0.11 mEq/L
Standard Error 0.164
|
-0.11 mEq/L
Standard Error 0.077
|
|
Laboratory Values - CMP (mEq/L)
Sodium - Baseline
|
142.0 mEq/L
Standard Error 0.76
|
140.5 mEq/L
Standard Error 0.53
|
|
Laboratory Values - CMP (mEq/L)
Sodium - Week 24
|
-0.9 mEq/L
Standard Error 0.85
|
1.0 mEq/L
Standard Error 0.47
|
|
Laboratory Values - CMP (mEq/L)
Sodium - Week 52
|
-0.4 mEq/L
Standard Error 0.51
|
0.7 mEq/L
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in CMP laboratory values with units of mL/min/1.73m\^2.
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - CMP (mL/Min/1.73m^2)
Glomerular Filtration Rate (eGFR) - Baseline
|
99.5 mL/min/1.73m^2
Standard Error 2.41
|
94.4 mL/min/1.73m^2
Standard Error 5.65
|
|
Laboratory Values - CMP (mL/Min/1.73m^2)
Glomerular Filtration Rate (eGFR) - Week 24
|
-1.7 mL/min/1.73m^2
Standard Error 2.28
|
0.2 mL/min/1.73m^2
Standard Error 3.18
|
|
Laboratory Values - CMP (mL/Min/1.73m^2)
Glomerular Filtration Rate (eGFR) - Week 52
|
-0.8 mL/min/1.73m^2
Standard Error 1.75
|
-2.7 mL/min/1.73m^2
Standard Error 3.99
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in CMP laboratory values with units of Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL).
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))
Calc BUN/Creat - Baseline
|
19.7 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)
Standard Error 2.44
|
16.3 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)
Standard Error 1.00
|
|
Laboratory Values - CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))
Calc BUN/Creat - Week 24
|
-0.6 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)
Standard Error 1.43
|
0.4 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)
Standard Error 1.61
|
|
Laboratory Values - CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))
Calc BUN/Creat - Week 52
|
2.5 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)
Standard Error 1.15
|
-0.6 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)
Standard Error 1.59
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in Coagulation Panel values with units of seconds.
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values - Coagulation Panel (Seconds)
PTT - Week 24
|
0.73 Seconds
Standard Error 0.936
|
-0.88 Seconds
Standard Error 0.528
|
|
Laboratory Values - Coagulation Panel (Seconds)
Prothrombin Time (PT) - Baseline
|
12.95 Seconds
Standard Error 0.183
|
13.23 Seconds
Standard Error 0.152
|
|
Laboratory Values - Coagulation Panel (Seconds)
Prothrombin Time (PT) - Week 24
|
1.00 Seconds
Standard Error 0.833
|
0.08 Seconds
Standard Error 0.096
|
|
Laboratory Values - Coagulation Panel (Seconds)
Prothrombin Time (PT) - Week 52
|
1.28 Seconds
Standard Error 1.064
|
0.12 Seconds
Standard Error 0.049
|
|
Laboratory Values - Coagulation Panel (Seconds)
PTT - Baseline
|
29.78 Seconds
Standard Error 1.056
|
30.06 Seconds
Standard Error 0.618
|
|
Laboratory Values - Coagulation Panel (Seconds)
PTT - Week 52
|
2.63 Seconds
Standard Error 1.712
|
-1.22 Seconds
Standard Error 0.707
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .
Changes from baseline in Coagulation laboratory values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds).
Outcome measures
| Measure |
Treatment
n=12 Participants
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 Participants
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))
INR - Baseline
|
0.94 Ratio: PT (seconds) / MNPT (seconds)
Standard Error 0.019
|
0.96 Ratio: PT (seconds) / MNPT (seconds)
Standard Error 0.015
|
|
Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))
INR - Week 24
|
0.11 Ratio: PT (seconds) / MNPT (seconds)
Standard Error 0.092
|
0.04 Ratio: PT (seconds) / MNPT (seconds)
Standard Error 0.016
|
|
Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))
INR - Week 52
|
0.14 Ratio: PT (seconds) / MNPT (seconds)
Standard Error 0.119
|
0.02 Ratio: PT (seconds) / MNPT (seconds)
Standard Error 0.013
|
Adverse Events
Treatment
Placebo
Serious adverse events
| Measure |
Treatment
n=12 participants at risk
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 participants at risk
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Vascular disorders
Deep Vein Thrombosis
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Infections and infestations
Cellulitis of arm
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
Other adverse events
| Measure |
Treatment
n=12 participants at risk
Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
Placebo
n=12 participants at risk
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify.
|
|---|---|---|
|
Nervous system disorders
Headache
|
66.7%
8/12 • Number of events 16 • Baseline (Week 0) through End of Study (Week 52)
|
41.7%
5/12 • Number of events 15 • Baseline (Week 0) through End of Study (Week 52)
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
16.7%
2/12 • Number of events 3 • Baseline (Week 0) through End of Study (Week 52)
|
|
Nervous system disorders
Paraesthesia
|
16.7%
2/12 • Number of events 2 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Nervous system disorders
Hyperreflexia
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Nervous system disorders
Migraine
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Nervous system disorders
Multiple Sclerosis relapse
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 5 • Baseline (Week 0) through End of Study (Week 52)
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Nervous system disorders
White matter lesion
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
General disorders
Fatigue
|
25.0%
3/12 • Number of events 3 • Baseline (Week 0) through End of Study (Week 52)
|
41.7%
5/12 • Number of events 10 • Baseline (Week 0) through End of Study (Week 52)
|
|
General disorders
Feeling abnormal
|
8.3%
1/12 • Number of events 2 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
General disorders
Asthenia
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
General disorders
Chest pain
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
General disorders
Feeling cold
|
8.3%
1/12 • Number of events 2 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
General disorders
Feeling hot
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
16.7%
2/12 • Number of events 2 • Baseline (Week 0) through End of Study (Week 52)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Infections and infestations
Cellulitis
|
16.7%
2/12 • Number of events 2 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Infections and infestations
Groin abscess
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Infections and infestations
Herpes zoster
|
16.7%
2/12 • Number of events 2 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Infections and infestations
COVID-19
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 5 • Baseline (Week 0) through End of Study (Week 52)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Psychiatric disorders
Anger
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Psychiatric disorders
Irritability
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Psychiatric disorders
Mood swings
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnea syndrome
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Vascular disorders
Deep vein thrombosis
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Vascular disorders
Hot flush
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Vascular disorders
Peripheral venous disease
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
|
Eye disorders
Vernal keratoconjunctivitis
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Investigations
Muscle strength abnormal
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • Baseline (Week 0) through End of Study (Week 52)
|
8.3%
1/12 • Number of events 1 • Baseline (Week 0) through End of Study (Week 52)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place