Trial Outcomes & Findings for A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy (NCT NCT04063215)
NCT ID: NCT04063215
Last Updated: 2026-01-15
Results Overview
Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Oxygen Saturation
COMPLETED
PHASE1/PHASE2
24 participants
Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
2026-01-15
Participant Flow
Participant milestones
| Measure |
Treatment Group
HB-adMSCs will be infused three times over a six week period, spaced 14 days apart
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
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|---|---|
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Overall Study
STARTED
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24
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
4
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy
Baseline characteristics by cohort
| Measure |
Treatment Group
n=24 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.
|
|---|---|
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Sex: Female, Male
Female
|
9 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Weight
|
73 kg
STANDARD_DEVIATION 19 • n=14 Participants
|
|
Height
|
175 cm
STANDARD_DEVIATION 14 • n=14 Participants
|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 10 • n=14 Participants
|
|
Age, Customized
|
33 Years
n=14 Participants
|
PRIMARY outcome
Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Respiratory Rate
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Vital Signs (Respiratory Rate)
Screening/Pre-Infusion (Visit 1)
|
16.54 breaths/min
Standard Deviation 1.22
|
|
Vital Signs (Respiratory Rate)
Infusion 1/Baseline (Visit 3 - Week 0)
|
16.82 breaths/min
Standard Deviation 1.59
|
|
Vital Signs (Respiratory Rate)
6 months Post-Infusion (Visit 6 - Week 28)
|
16.63 breaths/min
Standard Deviation 0.96
|
|
Vital Signs (Respiratory Rate)
1 year Post-Infusion (Visit 7 - Week 56)
|
16.42 breaths/min
Standard Deviation 0.84
|
PRIMARY outcome
Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Temperature
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Vital Signs (Temperature)
Screening/Pre-Infusion (Visit 1)
|
36.76 degrees Celsius
Standard Deviation 0.55
|
|
Vital Signs (Temperature)
Infusion 1/Baseline (Visit 3 - Week 0)
|
42.49 degrees Celsius
Standard Deviation 18.18
|
|
Vital Signs (Temperature)
6 months Post-Infusion (Visit 6 - Week 28)
|
39.85 degrees Celsius
Standard Deviation 13.68
|
|
Vital Signs (Temperature)
1 year Post-Infusion (Visit 7 - Week 56)
|
39.96 degrees Celsius
Standard Deviation 14.08
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PRIMARY outcome
Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Systolic Blood Pressure
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Vital Signs (Systolic Blood Pressure)
6 months Post-Infusion (Visit 6 - Week 28)
|
117 mmHg
Standard Deviation 14
|
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Vital Signs (Systolic Blood Pressure)
Screening/Pre-Infusion (Visit 1)
|
119 mmHg
Standard Deviation 16
|
|
Vital Signs (Systolic Blood Pressure)
Infusion 1/Baseline (Visit 3 - Week 0)
|
119 mmHg
Standard Deviation 14
|
|
Vital Signs (Systolic Blood Pressure)
1 year Post-Infusion (Visit 7 - Week 56)
|
119 mmHg
Standard Deviation 14
|
PRIMARY outcome
Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Diastolic Blood Pressure
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Vital Signs (Diastolic Blood Pressure)
1 year Post-Infusion (Visit 7 - Week 56)
|
74 mmHg
Standard Deviation 8
|
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Vital Signs (Diastolic Blood Pressure)
Infusion 1/Baseline (Visit 3 - Week 0)
|
72 mmHg
Standard Deviation 8
|
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Vital Signs (Diastolic Blood Pressure)
6 months Post-Infusion (Visit 6 - Week 28)
|
74 mmHg
Standard Deviation 10
|
|
Vital Signs (Diastolic Blood Pressure)
Screening/Pre-Infusion (Visit 1)
|
73 mmHg
Standard Deviation 9
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PRIMARY outcome
Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Pulse Rate
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Vital Signs (Pulse Rate)
Infusion 1/Baseline (Visit 3 - Week 0)
|
78 beats/min
Standard Deviation 9
|
|
Vital Signs (Pulse Rate)
6 months Post-Infusion (Visit 6 - Week 28)
|
80 beats/min
Standard Deviation 16
|
|
Vital Signs (Pulse Rate)
1 year Post-Infusion (Visit 7 - Week 56)
|
76 beats/min
Standard Deviation 13
|
|
Vital Signs (Pulse Rate)
Screening/Pre-Infusion (Visit 1)
|
80 beats/min
Standard Deviation 12
|
PRIMARY outcome
Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Oxygen Saturation
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Vital Signs (Oxygen Saturation)
Screening/Pre-Infusion (Visit 1)
|
98.87 % of oxygen
Standard Deviation 1.60
|
|
Vital Signs (Oxygen Saturation)
Infusion 1/Baseline (Visit 3 - Week 0)
|
98.68 % of oxygen
Standard Deviation 1.84
|
|
Vital Signs (Oxygen Saturation)
6 months Post-Infusion (Visit 6 - Week 28)
|
98.37 % of oxygen
Standard Deviation 1.74
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|
Vital Signs (Oxygen Saturation)
1 year Post-Infusion (Visit 7 - Week 56)
|
98.79 % of oxygen
Standard Deviation 1.25
|
PRIMARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Diastolic Blood Pressure
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Vital Signs Change From Baseline (Diastolic Blood Pressure)
Infusion 1/Baseline (Visit 3 - Week 0)
|
71.0 mmHg
Standard Deviation 10.42
|
|
Vital Signs Change From Baseline (Diastolic Blood Pressure)
Infusion 2 (Visit 4 - Week 2)
|
69.4 mmHg
Standard Deviation 10.24
|
|
Vital Signs Change From Baseline (Diastolic Blood Pressure)
Infusion 2 (Visit 4 - Week 2) Change from Baseline
|
-1.7 mmHg
Standard Deviation 8.69
|
|
Vital Signs Change From Baseline (Diastolic Blood Pressure)
Infusion 3 (Visit 5 - Week 4)
|
68.8 mmHg
Standard Deviation 9.31
|
|
Vital Signs Change From Baseline (Diastolic Blood Pressure)
Infusion 3 (Visit 5 - Week 4) Change from Baseline
|
-2.1 mmHg
Standard Deviation 8.81
|
PRIMARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Systolic Blood Pressure
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Vital Signs Change From Baseline (Systolic Blood Pressure)
Infusion 1/Baseline (Visit 3 - Week 0)
|
115.3 mmHg
Standard Deviation 14.73
|
|
Vital Signs Change From Baseline (Systolic Blood Pressure)
Infusion 2 (Visit 4 - Week 2)
|
113.8 mmHg
Standard Deviation 16.06
|
|
Vital Signs Change From Baseline (Systolic Blood Pressure)
Infusion 2 (Visit 4 - Week 2) Change from Baseline
|
-1.7 mmHg
Standard Deviation 11.10
|
|
Vital Signs Change From Baseline (Systolic Blood Pressure)
Infusion 3 (Visit 5 - Week 4)
|
114.3 mmHg
Standard Deviation 15.18
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Vital Signs Change From Baseline (Systolic Blood Pressure)
Infusion 3 (Visit 5 - Week 4) Change from Baseline
|
-1.0 mmHg
Standard Deviation 11.18
|
PRIMARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Pulse Rate
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Vital Signs Change From Baseline (Pulse Rate)
Infusion 1/Baseline (Visit 3 - Week 0)
|
72.0 beats/min
Standard Deviation 11.26
|
|
Vital Signs Change From Baseline (Pulse Rate)
Infusion 2 (Visit 4 - Week 2)
|
70.5 beats/min
Standard Deviation 11.15
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|
Vital Signs Change From Baseline (Pulse Rate)
Infusion 3 (Visit 5 - Week 4)
|
72.1 beats/min
Standard Deviation 11.02
|
|
Vital Signs Change From Baseline (Pulse Rate)
Infusion 3 (Visit 5 - Week 4) Change from Baseline
|
0.1 beats/min
Standard Deviation 11.15
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|
Vital Signs Change From Baseline (Pulse Rate)
Infusion 2 (Visit 4 - Week 2) Change from Baseline
|
-1.4 beats/min
Standard Deviation 10.79
|
PRIMARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Oxygen Saturation
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Vital Signs Change From Baseline (Oxygen Saturation)
Infusion 1/Baseline (Visit 3 - Week 0)
|
97.1 % of oxygen
Standard Deviation 4.63
|
|
Vital Signs Change From Baseline (Oxygen Saturation)
Infusion 2 (Visit 4 - Week 2)
|
97.5 % of oxygen
Standard Deviation 1.97
|
|
Vital Signs Change From Baseline (Oxygen Saturation)
Infusion 2 (Visit 4 - Week 2) Change from Baseline
|
0.4 % of oxygen
Standard Deviation 4.59
|
|
Vital Signs Change From Baseline (Oxygen Saturation)
Infusion 3 (Visit 5 - Week 4)
|
96.7 % of oxygen
Standard Deviation 5.15
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|
Vital Signs Change From Baseline (Oxygen Saturation)
Infusion 3 (Visit 5 - Week 4) Change from Baseline
|
-0.5 % of oxygen
Standard Deviation 6.82
|
PRIMARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Respiratory Rate
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Vital Signs Change From Baseline (Respiratory Rate)
Infusion 1/Baseline (Visit 3 - Week 0)
|
16.4 breaths/min
Standard Deviation 1.67
|
|
Vital Signs Change From Baseline (Respiratory Rate)
Infusion 2 (Visit 4 - Week 2)
|
16.4 breaths/min
Standard Deviation 1.14
|
|
Vital Signs Change From Baseline (Respiratory Rate)
Infusion 2 (Visit 4 - Week 2) Change from Baseline
|
0.0 breaths/min
Standard Deviation 1.40
|
|
Vital Signs Change From Baseline (Respiratory Rate)
Infusion 3 (Visit 5 - Week 4)
|
16.4 breaths/min
Standard Deviation 1.03
|
|
Vital Signs Change From Baseline (Respiratory Rate)
Infusion 3 (Visit 5 - Week 4) Change from Baseline
|
0.0 breaths/min
Standard Deviation 1.83
|
PRIMARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Temperature
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Vital Signs Change From Baseline (Temperature)
Infusion 1/Baseline (Visit 3 - Week 0)
|
36.7 degrees Celsius
Standard Deviation 0.29
|
|
Vital Signs Change From Baseline (Temperature)
Infusion 2 (Visit 4 - Week 2)
|
36.7 degrees Celsius
Standard Deviation 0.25
|
|
Vital Signs Change From Baseline (Temperature)
Infusion 2 (Visit 4 - Week 2) Change from Baseline
|
0.0 degrees Celsius
Standard Deviation 0.35
|
|
Vital Signs Change From Baseline (Temperature)
Infusion 3 (Visit 5 - Week 4)
|
36.7 degrees Celsius
Standard Deviation 0.29
|
|
Vital Signs Change From Baseline (Temperature)
Infusion 3 (Visit 5 - Week 4) Change from Baseline
|
-0.0 degrees Celsius
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
IL-4 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 1940 pg/mL to 6060 pg/mL
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Interleukin 4
Infusion 1/Baseline (Visit 3 - Week 0)
|
2694 pg/mL
Standard Deviation 939
|
|
Interleukin 4
6 months Post-Infusion (Visit 6 - Week 28)
|
4236 pg/mL
Standard Deviation 2561
|
|
Interleukin 4
1 year Post-Infusion (Visit 7 - Week 56)
|
3388 pg/mL
Standard Deviation 1296
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
IL-2 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 363 pg/mL to 1909 pg/mL
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Interleukin 2
Infusion 1/Baseline (Visit 3 - Week 0)
|
652 pg/mL
Standard Deviation 221
|
|
Interleukin 2
6 months Post-Infusion (Visit 6 - Week 28)
|
828 pg/mL
Standard Deviation 517
|
|
Interleukin 2
1 year Post-Infusion (Visit 7 - Week 56)
|
973 pg/mL
Standard Deviation 324
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
IL-1-beta lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 1615 pg/mL to 6930 pg/mL
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Interleukin 1-beta
Infusion 1/Baseline (Visit 3 - Week 0)
|
3267 pg/mL
Standard Deviation 780
|
|
Interleukin 1-beta
6 months Post-Infusion (Visit 6 - Week 28)
|
3709 pg/mL
Standard Deviation 1763
|
|
Interleukin 1-beta
1 year Post-Infusion (Visit 7 - Week 56)
|
3478 pg/mL
Standard Deviation 1226
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
IP-10 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 5270 pg/mL to 15466 pg/mL
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Interferon Gamma-induced Protein 10 (IP-10)
Infusion 1/Baseline (Visit 3 - Week 0)
|
8090 pg/mL
Standard Deviation 2762
|
|
Interferon Gamma-induced Protein 10 (IP-10)
6 months Post-Infusion (Visit 6 - Week 28)
|
8158 pg/mL
Standard Deviation 2210
|
|
Interferon Gamma-induced Protein 10 (IP-10)
1 year Post-Infusion (Visit 7 - Week 56)
|
7426 pg/mL
Standard Deviation 1828
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
TNFα lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 232 pg/mL to 4570 pg/mL
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Tumor Necrosis Factor Alpha
Infusion 1/Baseline (Visit 3 - Week 0)
|
1246 pg/mL
Standard Deviation 775
|
|
Tumor Necrosis Factor Alpha
6 months Post-Infusion (Visit 6 - Week 28)
|
1694 pg/mL
Standard Deviation 1497
|
|
Tumor Necrosis Factor Alpha
1 year Post-Infusion (Visit 7 - Week 56)
|
1553 pg/mL
Standard Deviation 609
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MCP-1 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 1439 pg/mL to 7472 pg/mL
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Monocyte Chemoattractant Protein-1 (MCP-1)
Infusion 1/Baseline (Visit 3 - Week 0)
|
4600 pg/mL
Standard Deviation 1602
|
|
Monocyte Chemoattractant Protein-1 (MCP-1)
6 months Post-Infusion (Visit 6 - Week 28)
|
4745 pg/mL
Standard Deviation 1122
|
|
Monocyte Chemoattractant Protein-1 (MCP-1)
1 year Post-Infusion (Visit 7 - Week 56)
|
5090 pg/mL
Standard Deviation 833
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
IL-17a lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values measure 526 pg/mL to 3228 pg/mL
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Interleukin Protein-17A (IL-17a)
Infusion 1/Baseline (Visit 3 - Week 0)
|
1529 pg/mL
Standard Deviation 532
|
|
Interleukin Protein-17A (IL-17a)
6 months Post-Infusion (Visit 6 - Week 28)
|
1410 pg/mL
Standard Deviation 827
|
|
Interleukin Protein-17A (IL-17a)
1 year Post-Infusion (Visit 7 - Week 56)
|
1736 pg/mL
Standard Deviation 639
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
IL-6 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 750 pg/mL to 4740 pg/mL
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Interleukin 6
Infusion 1/Baseline (Visit 3 - Week 0)
|
1501 pg/mL
Standard Deviation 574
|
|
Interleukin 6
6 months Post-Infusion (Visit 6 - Week 28)
|
1609 pg/mL
Standard Deviation 1379
|
|
Interleukin 6
1 year Post-Infusion (Visit 7 - Week 56)
|
1695 pg/mL
Standard Deviation 681
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
IL-10 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 497 pg/mL to 2796 pg/mL
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Interleukin 10
Infusion 1/Baseline (Visit 3 - Week 0)
|
1020 pg/mL
Standard Deviation 388
|
|
Interleukin 10
6 months Post-Infusion (Visit 6 - Week 28)
|
1129 pg/mL
Standard Deviation 777
|
|
Interleukin 10
1 year Post-Infusion (Visit 7 - Week 56)
|
1087 pg/mL
Standard Deviation 337
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
IFN-gamma lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 764 pg/mL to 6591 pg/mL
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
IFN-gamma
Infusion 1/Baseline (Visit 3 - Week 0)
|
1419 pg/mL
Standard Deviation 826
|
|
IFN-gamma
6 months Post-Infusion (Visit 6 - Week 28)
|
2940 pg/mL
Standard Deviation 1779
|
|
IFN-gamma
1 year Post-Infusion (Visit 7 - Week 56)
|
1696 pg/mL
Standard Deviation 679
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
IL-12p70 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 676 pg/mL to 3975 pg/mL
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
IL-12p70
Infusion 1/Baseline (Visit 3 - Week 0)
|
1835 pg/mL
Standard Deviation 385
|
|
IL-12p70
6 months Post-Infusion (Visit 6 - Week 28)
|
1708 pg/mL
Standard Deviation 1097
|
|
IL-12p70
1 year Post-Infusion (Visit 7 - Week 56)
|
1893 pg/mL
Standard Deviation 652
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
IL-8 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 1348 pg/mL to 7738 pg/mL
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
IL-8
Infusion 1/Baseline (Visit 3 - Week 0)
|
2477 pg/mL
Standard Deviation 927
|
|
IL-8
6 months Post-Infusion (Visit 6 - Week 28)
|
3667 pg/mL
Standard Deviation 2161
|
|
IL-8
1 year Post-Infusion (Visit 7 - Week 56)
|
3023 pg/mL
Standard Deviation 1181
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Free active TGF-Beta1 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 799 pg/mL to 7374 pg/mL
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Free Active TGF-Beta1
Infusion 1/Baseline (Visit 3 - Week 0)
|
1684 pg/mL
Standard Deviation 1580
|
|
Free Active TGF-Beta1
6 months Post-Infusion (Visit 6 - Week 28)
|
2252 pg/mL
Standard Deviation 2251
|
|
Free Active TGF-Beta1
1 year Post-Infusion (Visit 7 - Week 56)
|
1755 pg/mL
Standard Deviation 1244
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Count of Participants with specific GOS-E scores at Visits 3, 6, and 7 Glasgow Outcome Scale-Extended is an 8-point scale that classifies the global outcome for individuals with traumatic brain injury (TBI), ranging from 1 (dead) to 8 (upper good recovery). The categorical rating is based on a structured interview about the patient's ability to function. Higher scores indicate better recovery. Category 3 is Lower Severe Disability, Category 4 is Upper Severe Disability, Category 5 is Lower Moderate Disability, and Category 6 is Upper Moderate Disability.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes
Category 3 at Infusion 1/Baseline (Visit 3 - Week 0)
|
7 Participants
|
|
Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes
Category 4 at Infusion 1/Baseline (Visit 3 - Week 0)
|
5 Participants
|
|
Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes
Category 5 at Infusion 1/Baseline (Visit 3 - Week 0)
|
2 Participants
|
|
Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes
Category 6 at Infusion 1/Baseline (Visit 3 - Week 0)
|
10 Participants
|
|
Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes
Category 3 at 6 months Post-Infusion (Visit 6 - Week 28)
|
6 Participants
|
|
Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes
Category 4 at 6 months Post-Infusion (Visit 6 - Week 28)
|
3 Participants
|
|
Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes
Category 5 at 6 months Post-Infusion (Visit 6 - Week 28)
|
2 Participants
|
|
Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes
Category 6 at 6 months Post-Infusion (Visit 6 - Week 28)
|
9 Participants
|
|
Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes
Category 3 at 1 year Post-Infusion (Visit 7 - Week 56)
|
5 Participants
|
|
Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes
Category 4 at 1 year Post-Infusion (Visit 7 - Week 56)
|
2 Participants
|
|
Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes
Category 5 at 1 year Post-Infusion (Visit 7 - Week 56)
|
3 Participants
|
|
Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes
Category 6 at 1 year Post-Infusion (Visit 7 - Week 56)
|
10 Participants
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Mean and SD of Disability Rating Scale (DRS) evaluation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The Disability Rating Scale score provides a numerical measure of an individual's functional impairment and disability. This assessment uses a 0-30 total score to assess traumatic brain injury, with higher scores indicating greater disability. A score of 0 indicates a rating of "no disability" and a score of 30 indicates a rating of "profound vegetative state".
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Disability Rating Scale (DRS) Functional Outcomes
Infusion 1/Baseline (Visit 3 - Week 0)
|
4.54 score on a scale
Standard Deviation 3.89
|
|
Disability Rating Scale (DRS) Functional Outcomes
6 months Post-Infusion (Visit 6 - Week 28)
|
4.65 score on a scale
Standard Deviation 4.07
|
|
Disability Rating Scale (DRS) Functional Outcomes
1 year Post-Infusion (Visit 7 - Week 56)
|
3.30 score on a scale
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Mean and SD of Galveston Orientation and Amnesia Test (GOAT) evaluation of cognition at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The total score is calculated by subtracting an "error score" from 100. The error score is calculated by summing together the individual error score points from each question. The minimum total score of -3 is associated with a failure to respond correctly to any memory/orientation question. A total score of 100 indicates perfect recall on the GOAT memory/orientation questions. Higher total scores indicate better recall.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Galveston Orientation and Amnesia Test Neuropsychological Outcomes
Infusion 1/Baseline (Visit 3 - Week 0)
|
91.74 score on a scale
Standard Deviation 7.81
|
|
Galveston Orientation and Amnesia Test Neuropsychological Outcomes
6 months Post-Infusion (Visit 6 - Week 28)
|
95.89 score on a scale
Standard Deviation 4.93
|
|
Galveston Orientation and Amnesia Test Neuropsychological Outcomes
1 year Post-Infusion (Visit 7 - Week 56)
|
96.10 score on a scale
Standard Deviation 4.56
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Brief Symptoms Inventory 18 (BSI 18) Somatization (SOM) T-Score Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. A T-score is then calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Brief Symptoms Inventory 18 (BSI 18) SOM T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
56.52 t-score
Standard Deviation 9.85
|
|
Brief Symptoms Inventory 18 (BSI 18) SOM T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
52.42 t-score
Standard Deviation 8.93
|
|
Brief Symptoms Inventory 18 (BSI 18) SOM T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
51.60 t-score
Standard Deviation 7.86
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Brief Symptoms Inventory 18 (BSI 18) Depression (DEP) T-Score Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. A T-score is then calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Brief Symptoms Inventory 18 (BSI 18) DEP T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
57.17 t-score
Standard Deviation 12.83
|
|
Brief Symptoms Inventory 18 (BSI 18) DEP T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
52.58 t-score
Standard Deviation 11.65
|
|
Brief Symptoms Inventory 18 (BSI 18) DEP T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
51.00 t-score
Standard Deviation 11.68
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Brief Symptoms Inventory 18 (BSI 18) Anxiety (ANX) T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. A T-score is then calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Brief Symptoms Inventory 18 (BSI 18) Anxiety (ANX) T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
54.74 t-score
Standard Deviation 10.85
|
|
Brief Symptoms Inventory 18 (BSI 18) Anxiety (ANX) T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
48.37 t-score
Standard Deviation 9.06
|
|
Brief Symptoms Inventory 18 (BSI 18) Anxiety (ANX) T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
47.85 t-score
Standard Deviation 8.71
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Brief Symptoms Inventory 18 (BSI 18) Global Severity Index (GSI) T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. The Global Severity Index (GSI) is the sum of the three subscores, which was then normalized with a t-score in this analysis. A T-score was calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Brief Symptoms Inventory 18 (BSI 18) Global Severity Index (GSI) T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
57.48 t-score
Standard Deviation 11.14
|
|
Brief Symptoms Inventory 18 (BSI 18) Global Severity Index (GSI) T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
52.00 t-score
Standard Deviation 10.37
|
|
Brief Symptoms Inventory 18 (BSI 18) Global Severity Index (GSI) T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
50.60 t-score
Standard Deviation 10.69
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
TBI Quality of Life Questionnaires (TBI-QOL SF) - Cognition - General Concerns T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Cognition - General Concerns T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
37.29 t-score
Standard Deviation 8.85
|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Cognition - General Concerns T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
41.85 t-score
Standard Deviation 7.01
|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Cognition - General Concerns T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
42.72 t-score
Standard Deviation 9.01
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
TBI Quality of Life Questionnaires (TBI-QOL SF) - Communication T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Communication T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
47.76 t-score
Standard Deviation 8.91
|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Communication T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
52.18 t-score
Standard Deviation 7.08
|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Communication T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
52.39 t-score
Standard Deviation 10.60
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
TBI Quality of Life Questionnaires (TBI-QOL SF) - Independence T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Independence T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
40.10 t-score
Standard Deviation 8.82
|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Independence T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
43.51 t-score
Standard Deviation 8.82
|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Independence T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
44.95 t-score
Standard Deviation 7.70
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
TBI Quality of Life Questionnaires (TBI-QOL SF) - Mobility T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Mobility T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
39.36 t-score
Standard Deviation 11.85
|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Mobility T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
40.12 t-score
Standard Deviation 11.73
|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Mobility T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
40.73 t-score
Standard Deviation 11.30
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
TBI Quality of Life Questionnaires (TBI-QOL SF) - Satisfaction with SRA T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Satisfaction With SRA T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
41.96 t-score
Standard Deviation 6.50
|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Satisfaction With SRA T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
44.53 t-score
Standard Deviation 4.26
|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Satisfaction With SRA T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
44.35 t-score
Standard Deviation 5.04
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
TBI Quality of Life Questionnaires (TBI-QOL SF) - Upper Extremity/ADL T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Upper Extremity/ADL T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
37.20 t-score
Standard Deviation 10.98
|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Upper Extremity/ADL T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
36.65 t-score
Standard Deviation 9.76
|
|
TBI Quality of Life Questionnaires (TBI-QOL SF) - Upper Extremity/ADL T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
38.74 t-score
Standard Deviation 9.39
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
NIH Toolbox - Cognition: Pattern Comparison Processing Speed Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
NIH Toolbox - Cognition: Pattern Comparison Processing Speed Test T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
30.65 t-score
Standard Deviation 14.11
|
|
NIH Toolbox - Cognition: Pattern Comparison Processing Speed Test T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
35.42 t-score
Standard Deviation 17.12
|
|
NIH Toolbox - Cognition: Pattern Comparison Processing Speed Test T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
39.68 t-score
Standard Deviation 18.35
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
NIH Toolbox - Cognition: Picture Vocabulary Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
NIH Toolbox - Cognition: Picture Vocabulary Test T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
41.96 t-score
Standard Deviation 8.48
|
|
NIH Toolbox - Cognition: Picture Vocabulary Test T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
43.74 t-score
Standard Deviation 9.56
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
NIH Toolbox - Cognition: Dimensional Change Card Sort Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
NIH Toolbox - Cognition: Dimensional Change Card Sort Test T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
36.65 t-score
Standard Deviation 8.95
|
|
NIH Toolbox - Cognition: Dimensional Change Card Sort Test T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
38.05 t-score
Standard Deviation 8.57
|
|
NIH Toolbox - Cognition: Dimensional Change Card Sort Test T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
40.47 t-score
Standard Deviation 11.89
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
NIH Toolbox - Cognition: Franker Inhibitory Control and Attention Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
NIH Toolbox - Cognition: Franker Inhibitory Control and Attention Test T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
31.68 t-score
Standard Deviation 10.83
|
|
NIH Toolbox - Cognition: Franker Inhibitory Control and Attention Test T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
28.58 t-score
Standard Deviation 9.81
|
|
NIH Toolbox - Cognition: Franker Inhibitory Control and Attention Test T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
31.58 t-score
Standard Deviation 10.04
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
NIH Toolbox - Cognition: List Sorting Working Memory Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
NIH Toolbox - Cognition: List Sorting Working Memory Test T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
40.43 t-score
Standard Deviation 9.61
|
|
NIH Toolbox - Cognition: List Sorting Working Memory Test T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
39.37 t-score
Standard Deviation 9.33
|
|
NIH Toolbox - Cognition: List Sorting Working Memory Test T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
43.00 t-score
Standard Deviation 10.96
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
26.81 t-score
Standard Deviation 13.21
|
|
NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
27.61 t-score
Standard Deviation 13.28
|
|
NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
27.94 t-score
Standard Deviation 15.28
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test Non-Dominant Hands T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test Non-Dominant Hands T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
26.21 t-score
Standard Deviation 18.82
|
|
NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test Non-Dominant Hands T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
20.20 t-score
Standard Deviation 15.06
|
|
NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test Non-Dominant Hands T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
25.09 t-score
Standard Deviation 20.43
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Rey Auditory Verbal Learning Test (RAVLT) Delay T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The Rey Auditory Verbal Learning Test (RAVLT) Delay Test consists of calculating the total number of words recalled on the delayed recall trial (after a 20-30 minute delay). Then, a T-score is calculated by comparing to normative data adjusted for age and education to determine performance relative to peers. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more words were recalled (better outcomes). Technically there is no minimum or maximum t-score since it is normalized.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Rey Auditory Verbal Learning Test (RAVLT) Delay T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
31.95 t-score
Standard Deviation 16.24
|
|
Rey Auditory Verbal Learning Test (RAVLT) Delay T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
30.57 t-score
Standard Deviation 19.02
|
|
Rey Auditory Verbal Learning Test (RAVLT) Delay T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
37.49 t-score
Standard Deviation 19.20
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 Test consists of calculating the total number of words correctly recalled across the five initial learning trials (Trials 1-5). Then, a T-score is calculated by comparing to normative data adjusted for age and education to determine performance relative to peers. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more words were recalled (better outcomes). Technically there is no minimum or maximum t-score since it is normalized.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 T Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
28.42 t-score
Standard Deviation 14.76
|
|
Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 T Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
31.01 t-score
Standard Deviation 16.34
|
|
Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 T Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
36.74 t-score
Standard Deviation 16.94
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Wechsler Adult Intelligence Scale - IV: Coding Scaled Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The subsection (such as Coding) raw scores are converted into a scaled score with a mean of 10 and a standard deviation of 3. This process is standardized using age-based conversion tables. Then, these scaled scores are combined into index scores which are compared to a normative population with a standard score (mean = 100, SD = 15) to create an index score and fall into ranges of "Average" being 90-109, "High Average" 110-119, "Low Average" 80-89, "Borderline" 70-79, and "Extremely Low" below 70. Higher scores mean better outcome.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Wechsler Adult Intelligence Scale - IV: Coding Scaled Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
6.58 score on a scale
Standard Deviation 3.29
|
|
Wechsler Adult Intelligence Scale - IV: Coding Scaled Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
5.88 score on a scale
Standard Deviation 3.18
|
|
Wechsler Adult Intelligence Scale - IV: Coding Scaled Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
6.71 score on a scale
Standard Deviation 3.69
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Wechsler Adult Intelligence Scale - IV: Symbol Search Scaled Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The subsection (such as Coding) raw scores are converted into a scaled score with a mean of 10 and a standard deviation of 3. This process is standardized using age-based conversion tables. Then, these scaled scores are combined into index scores which are compared to a normative population with a standard score (mean = 100, SD = 15) to create an index score and fall into ranges of "Average" being 90-109, "High Average" 110-119, "Low Average" 80-89, "Borderline" 70-79, and "Extremely Low" below 70. Higher scores mean better outcome.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Wechsler Adult Intelligence Scale - IV: Symbol Search Scaled Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
6.24 score on a scale
Standard Deviation 3.73
|
|
Wechsler Adult Intelligence Scale - IV: Symbol Search Scaled Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
6.06 score on a scale
Standard Deviation 2.88
|
|
Wechsler Adult Intelligence Scale - IV: Symbol Search Scaled Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
6.83 score on a scale
Standard Deviation 3.81
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Wechsler Adult Intelligence Scale - IV: Processing Speed Composite Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The subsection (such as Coding) raw scores are converted into a scaled score with a mean of 10 and a standard deviation of 3. This process is standardized using age-based conversion tables. Then, these scaled scores are combined into index scores which are compared to a normative population with a standard score (mean = 100, SD = 15) to create an index score and fall into ranges of "Average" being 90-109, "High Average" 110-119, "Low Average" 80-89, "Borderline" 70-79, and "Extremely Low" below 70. Higher scores mean better outcome.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Wechsler Adult Intelligence Scale - IV: Processing Speed Index/Composite Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
82.05 score on a scale
Standard Deviation 17.62
|
|
Wechsler Adult Intelligence Scale - IV: Processing Speed Index/Composite Scores
6 months Post-Infusion (Visit 6 - Week 28)
|
79.44 score on a scale
Standard Deviation 15.12
|
|
Wechsler Adult Intelligence Scale - IV: Processing Speed Index/Composite Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
83.24 score on a scale
Standard Deviation 19.23
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
Controlled Oral Word Association Test (COWAT) Total Scaled Scores Mean and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The COWAT is scored by counting the number of correct words a person produces in one minute for each of the three given letters. The total score is the sum of the unique words generated across all three trials. Higher scores are considered a better outcome. The raw total score is then compared to normative data that is based on factors such as age and education level. The scaled score has a mean of 10 and a standard deviation of 3. A t-score of \< 20 indicates severe impairment.
Outcome measures
| Measure |
HB-adMSC
n=24 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Controlled Oral Word Association Test (COWAT) Total Scaled Scores
Infusion 1/Baseline (Visit 3 - Week 0)
|
8.88 score on a scale
Standard Deviation 3.26
|
|
Controlled Oral Word Association Test (COWAT) Total Scaled Scores
Month 66 months Post-Infusion (Visit 6 - Week 28)
|
8.69 score on a scale
Standard Deviation 2.30
|
|
Controlled Oral Word Association Test (COWAT) Total Scaled Scores
1 year Post-Infusion (Visit 7 - Week 56)
|
10.00 score on a scale
Standard Deviation 2.65
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Global White Matter Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Global White Matter
Infusion 1/Baseline (Visit 3 - Week 0)
|
114,303 SupraMD volume (mm3)
Standard Deviation 29,555
|
|
MRI Structural Measures - Global White Matter
6 months Post-Infusion (Visit 6 - Week 28)
|
108,002 SupraMD volume (mm3)
Standard Deviation 25,752
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Global Gray Matter Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Global Gray Matter
Infusion 1/Baseline (Visit 3 - Week 0)
|
430,058 SupraMD volume (mm3)
Standard Deviation 45,653
|
|
MRI Structural Measures - Global Gray Matter
6 months Post-Infusion (Visit 6 - Week 28)
|
427,864 SupraMD volume (mm3)
Standard Deviation 54,441
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Global Corpus Callosum Matter Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Global Corpus Callosum Matter
Infusion 1/Baseline (Visit 3 - Week 0)
|
836 SupraMD volume (mm3)
Standard Deviation 274
|
|
MRI Structural Measures - Global Corpus Callosum Matter
6 months Post-Infusion (Visit 6 - Week 28)
|
757 SupraMD volume (mm3)
Standard Deviation 258
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Hippocampus (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Hippocampus (Bilateral)
Infusion 1/Baseline (Visit 3 - Week 0)
|
6,475 SupraMD volume (mm3)
Standard Deviation 1,071
|
|
MRI Structural Measures - Hippocampus (Bilateral)
6 months Post-Infusion (Visit 6 - Week 28)
|
6,281 SupraMD volume (mm3)
Standard Deviation 1,082
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Amygdala (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Amygdala (Bilateral)
6 months Post-Infusion (Visit 6 - Week 28)
|
1,794 SupraMD volume (mm3)
Standard Deviation 496
|
|
MRI Structural Measures - Amygdala (Bilateral)
Infusion 1/Baseline (Visit 3 - Week 0)
|
1,926 SupraMD volume (mm3)
Standard Deviation 457
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Thalamus (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Thalamus (Bilateral)
Infusion 1/Baseline (Visit 3 - Week 0)
|
4,952 SupraMD volume (mm3)
Standard Deviation 798
|
|
MRI Structural Measures - Thalamus (Bilateral)
6 months Post-Infusion (Visit 6 - Week 28)
|
4,700 SupraMD volume (mm3)
Standard Deviation 778
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Caudate (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Caudate (Bilateral)
Infusion 1/Baseline (Visit 3 - Week 0)
|
3,760 SupraMD volume (mm3)
Standard Deviation 771
|
|
MRI Structural Measures - Caudate (Bilateral)
6 months Post-Infusion (Visit 6 - Week 28)
|
3,523 SupraMD volume (mm3)
Standard Deviation 636
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Putamen (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Putamen (Bilateral)
Infusion 1/Baseline (Visit 3 - Week 0)
|
901 SupraMD volume (mm3)
Standard Deviation 1169
|
|
MRI Structural Measures - Putamen (Bilateral)
6 months Post-Infusion (Visit 6 - Week 28)
|
951 SupraMD volume (mm3)
Standard Deviation 1396
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Pallidum (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Pallidum (Bilateral)
Infusion 1/Baseline (Visit 3 - Week 0)
|
450 SupraMD volume (mm3)
Standard Deviation 393
|
|
MRI Structural Measures - Pallidum (Bilateral)
6 months Post-Infusion (Visit 6 - Week 28)
|
459 SupraMD volume (mm3)
Standard Deviation 448
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Insula (Bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Insula (Bilateral)
Infusion 1/Baseline (Visit 3 - Week 0)
|
4,985 SupraMD volume (mm3)
Standard Deviation 1,164
|
|
MRI Structural Measures - Insula (Bilateral)
6 months Post-Infusion (Visit 6 - Week 28)
|
4,772 SupraMD volume (mm3)
Standard Deviation 967
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Hippocampus (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Hippocampus (Left)
Infusion 1/Baseline (Visit 3 - Week 0)
|
3,180 SupraMD volume (mm3)
Standard Deviation 453
|
|
MRI Structural Measures - Hippocampus (Left)
6 months Post-Infusion (Visit 6 - Week 28)
|
3,140 SupraMD volume (mm3)
Standard Deviation 503
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Hippocampus (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Hippocampus (Right)
Infusion 1/Baseline (Visit 3 - Week 0)
|
3,295 SupraMD volume (mm3)
Standard Deviation 663
|
|
MRI Structural Measures - Hippocampus (Right)
6 months Post-Infusion (Visit 6 - Week 28)
|
3,141 SupraMD volume (mm3)
Standard Deviation 646
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Amygdala (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Amygdala (Left)
Infusion 1/Baseline (Visit 3 - Week 0)
|
870 SupraMD volume (mm3)
Standard Deviation 195
|
|
MRI Structural Measures - Amygdala (Left)
6 months Post-Infusion (Visit 6 - Week 28)
|
813 SupraMD volume (mm3)
Standard Deviation 243
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Amygdala (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Amygdala (Right)
Infusion 1/Baseline (Visit 3 - Week 0)
|
1,055 SupraMD volume (mm3)
Standard Deviation 326
|
|
MRI Structural Measures - Amygdala (Right)
6 months Post-Infusion (Visit 6 - Week 28)
|
982 SupraMD volume (mm3)
Standard Deviation 290
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Thalamus (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Thalamus (Left)
Infusion 1/Baseline (Visit 3 - Week 0)
|
2,522 SupraMD volume (mm3)
Standard Deviation 439
|
|
MRI Structural Measures - Thalamus (Left)
6 months Post-Infusion (Visit 6 - Week 28)
|
2,363 SupraMD volume (mm3)
Standard Deviation 437
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Thalamus (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Thalamus (Right)
Infusion 1/Baseline (Visit 3 - Week 0)
|
2,431 SupraMD volume (mm3)
Standard Deviation 388
|
|
MRI Structural Measures - Thalamus (Right)
6 months Post-Infusion (Visit 6 - Week 28)
|
2,337 SupraMD volume (mm3)
Standard Deviation 422
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Caudate (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Caudate (Left)
Infusion 1/Baseline (Visit 3 - Week 0)
|
1,786 SupraMD volume (mm3)
Standard Deviation 253
|
|
MRI Structural Measures - Caudate (Left)
6 months Post-Infusion (Visit 6 - Week 28)
|
1,679 SupraMD volume (mm3)
Standard Deviation 220
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Caudate (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Caudate (Right)
Infusion 1/Baseline (Visit 3 - Week 0)
|
1,974 SupraMD volume (mm3)
Standard Deviation 578
|
|
MRI Structural Measures - Caudate (Right)
6 months Post-Infusion (Visit 6 - Week 28)
|
1,844 SupraMD volume (mm3)
Standard Deviation 483
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Putamen (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Putamen (Left)
Infusion 1/Baseline (Visit 3 - Week 0)
|
224 SupraMD volume (mm3)
Standard Deviation 135
|
|
MRI Structural Measures - Putamen (Left)
6 months Post-Infusion (Visit 6 - Week 28)
|
199 SupraMD volume (mm3)
Standard Deviation 106
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Putamen (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Putamen (Right)
Infusion 1/Baseline (Visit 3 - Week 0)
|
678 SupraMD volume (mm3)
Standard Deviation 1,174
|
|
MRI Structural Measures - Putamen (Right)
6 months Post-Infusion (Visit 6 - Week 28)
|
752 SupraMD volume (mm3)
Standard Deviation 1,401
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Pallidum (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Pallidum (Left)
Infusion 1/Baseline (Visit 3 - Week 0)
|
179 SupraMD volume (mm3)
Standard Deviation 150
|
|
MRI Structural Measures - Pallidum (Left)
6 months Post-Infusion (Visit 6 - Week 28)
|
159 SupraMD volume (mm3)
Standard Deviation 125
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Pallidum (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Pallidum (Right)
Infusion 1/Baseline (Visit 3 - Week 0)
|
272 SupraMD volume (mm3)
Standard Deviation 319
|
|
MRI Structural Measures - Pallidum (Right)
6 months Post-Infusion (Visit 6 - Week 28)
|
300 SupraMD volume (mm3)
Standard Deviation 407
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Insula (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Insula (Left)
Infusion 1/Baseline (Visit 3 - Week 0)
|
2,071 SupraMD volume (mm3)
Standard Deviation 575
|
|
MRI Structural Measures - Insula (Left)
6 months Post-Infusion (Visit 6 - Week 28)
|
2,016 SupraMD volume (mm3)
Standard Deviation 422
|
SECONDARY outcome
Timeframe: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
MRI Structural Measures - Insula (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Outcome measures
| Measure |
HB-adMSC
n=20 Participants
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
MRI Structural Measures - Insula (Right)
Infusion 1/Baseline (Visit 3 - Week 0)
|
2,914 SupraMD volume (mm3)
Standard Deviation 748
|
|
MRI Structural Measures - Insula (Right)
6 months Post-Infusion (Visit 6 - Week 28)
|
2,756 SupraMD volume (mm3)
Standard Deviation 688
|
Adverse Events
HB-adMSC
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HB-adMSC
n=24 participants at risk
HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)
HB-adMSCs: Hope Biosciences autologous adipose-derived mesenchymal stem cells
|
|---|---|
|
Infections and infestations
COVID-19 Infection
|
16.7%
4/24 • Number of events 4 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
General disorders
Cold intolerance
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Nervous system disorders
Decreased sensitivity, left side of face
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Psychiatric disorders
Depression, worsening
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • Number of events 2 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Blood and lymphatic system disorders
Eosinophil count increased
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Nervous system disorders
Fall
|
12.5%
3/24 • Number of events 4 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
General disorders
Fatigue, increased
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Nervous system disorders
Gait disturbance
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
General disorders
Head cold
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • Number of events 3 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
8.3%
2/24 • Number of events 7 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Nervous system disorders
Insomnia
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
General disorders
Itchiness, face, left side
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
General disorders
Malaise
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
General disorders
Motor vehicle collision
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Musculoskeletal and connective tissue disorders
Pain, back
|
8.3%
2/24 • Number of events 2 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Musculoskeletal and connective tissue disorders
Pain, generalized joint and muscle
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Musculoskeletal and connective tissue disorders
Pain, tongue
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Nervous system disorders
Seizure
|
8.3%
2/24 • Number of events 5 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Nervous system disorders
Spasticity, left arm, increased, intermittent
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Eye disorders
Strabismus eye surgery
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Renal and urinary disorders
Urinary Tract Infection symptoms
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
|
Eye disorders
Vision, worsening, intermittent
|
4.2%
1/24 • Number of events 1 • Adverse events were recorded from the time of consent until the subject completed the final study visit or until the subject (or LAR) prematurely withdrew from participation (Week 0 to Week 108 - Screening to Follow-Up Call #2)
|
Additional Information
Carmen Duron
UTHealth, McGovern Medical School at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place