Trial Outcomes & Findings for Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19 (NCT NCT04362189)
NCT ID: NCT04362189
Last Updated: 2025-09-26
Results Overview
Change from baseline in Tumor Necrosis Factor-Alpha (TNF-alpha) in the blood (pg/mL)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Day 0, 3, 7, and 10
Results posted on
2025-09-26
Participant Flow
A total of 59 subjects were assessed for screening, out of which only 48 were enrolled and 11 failed screening. All 48 were randomized in to the two treatment arms: 100MM HB-adMSCs and placebo. 21 out of 48 randomized subjects discontinued.
A total of 59 subjects were assessed for screening, out of which only 48 were enrolled and 11 failed screening.
Participant milestones
| Measure |
HB-adMSCs
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
15
|
|
Overall Study
COMPLETED
|
18
|
9
|
|
Overall Study
NOT COMPLETED
|
15
|
6
|
Reasons for withdrawal
| Measure |
HB-adMSCs
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
FDA Clinical Hold
|
7
|
2
|
|
Overall Study
Discharge or Transfer to other Hospital
|
3
|
0
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Death
|
4
|
1
|
Baseline Characteristics
Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19
Baseline characteristics by cohort
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.2 Years
STANDARD_DEVIATION 17.6 • n=5 Participants
|
54.7 Years
STANDARD_DEVIATION 15.8 • n=7 Participants
|
53.7 Years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weight
|
194.6 lbs
STANDARD_DEVIATION 48.2 • n=5 Participants
|
194.1 lbs
STANDARD_DEVIATION 43.7 • n=7 Participants
|
194.4 lbs
STANDARD_DEVIATION 46.3 • n=5 Participants
|
|
Height
|
66.5 in
STANDARD_DEVIATION 3.5 • n=5 Participants
|
66.1 in
STANDARD_DEVIATION 4.4 • n=7 Participants
|
66.4 in
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Body Mass Index (BMI)
|
30.8 kg/m^2
STANDARD_DEVIATION 6.3 • n=5 Participants
|
31.2 kg/m^2
STANDARD_DEVIATION 5.9 • n=7 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 6.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0, 3, 7, and 10Change from baseline in Tumor Necrosis Factor-Alpha (TNF-alpha) in the blood (pg/mL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Tumor Necrosis Factor-Alpha (TNF-alpha)
Day 0 (Baseline)
|
15.5 pg/mL
Standard Deviation 13.9
|
18.2 pg/mL
Standard Deviation 12.3
|
|
Tumor Necrosis Factor-Alpha (TNF-alpha)
Day 3
|
26.1 pg/mL
Standard Deviation 26.5
|
15.9 pg/mL
Standard Deviation 10.0
|
|
Tumor Necrosis Factor-Alpha (TNF-alpha)
Day 7
|
33.4 pg/mL
Standard Deviation 49.8
|
35.3 pg/mL
Standard Deviation 38.8
|
|
Tumor Necrosis Factor-Alpha (TNF-alpha)
Day 10
|
20.3 pg/mL
Standard Deviation 11.3
|
30.5 pg/mL
Standard Deviation 40.5
|
PRIMARY outcome
Timeframe: Day 0, 3, 7, and 10Change from baseline level of Interleukin-10 (IL-10) in the blood (pg/mL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Interleukin-10 (IL-10)
Day 0 (Baseline)
|
16.3 pg/mL
Standard Deviation 19.4
|
11.9 pg/mL
Standard Deviation 16.6
|
|
Interleukin-10 (IL-10)
Day 3
|
18.8 pg/mL
Standard Deviation 39.1
|
44.7 pg/mL
Standard Deviation 98.9
|
|
Interleukin-10 (IL-10)
Day 7
|
30.8 pg/mL
Standard Deviation 86.3
|
27.2 pg/mL
Standard Deviation 65.1
|
|
Interleukin-10 (IL-10)
Day 10
|
13.0 pg/mL
Standard Deviation 13.5
|
8.4 pg/mL
Standard Deviation 10.8
|
PRIMARY outcome
Timeframe: Day 0, 3, 7, and 10Change from baseline in Interleukin-6 (IL-6) in the blood (pg/mL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Interleukin-6 (IL-6)
Day 0 (Baseline)
|
24.3 pg/mL
Standard Deviation 71.8
|
69.4 pg/mL
Standard Deviation 166.5
|
|
Interleukin-6 (IL-6)
Day 3
|
46.3 pg/mL
Standard Deviation 104.0
|
376.6 pg/mL
Standard Deviation 988.7
|
|
Interleukin-6 (IL-6)
Day 7
|
65.4 pg/mL
Standard Deviation 186.8
|
197.8 pg/mL
Standard Deviation 539.7
|
|
Interleukin-6 (IL-6)
Day 10
|
35.0 pg/mL
Standard Deviation 70.4
|
12.4 pg/mL
Standard Deviation 23.9
|
PRIMARY outcome
Timeframe: Day 0, 3, 7, and 10Change from baseline in C-Reactive Protein (CRP) in the blood (mg/L)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
C-Reactive Protein (CRP)
Day 0 (Baseline)
|
4.9 mg/L
Standard Deviation 5.8
|
3.8 mg/L
Standard Deviation 5.1
|
|
C-Reactive Protein (CRP)
Day 3
|
4.8 mg/L
Standard Deviation 7.5
|
4.5 mg/L
Standard Deviation 9.2
|
|
C-Reactive Protein (CRP)
Day 7
|
3.6 mg/L
Standard Deviation 3.4
|
2.2 mg/L
Standard Deviation 4.1
|
|
C-Reactive Protein (CRP)
Day 10
|
3.5 mg/L
Standard Deviation 4.8
|
0.2 mg/L
Standard Deviation 0.2
|
PRIMARY outcome
Timeframe: Day 0, 3, 7, and 10Change from baseline Oxygenation (%) in the blood
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Oxygenation
Day 0 (Baseline)
|
95.3 % of Oxygen Saturation
Standard Deviation 3.1
|
89.4 % of Oxygen Saturation
Standard Deviation 19.1
|
|
Oxygenation
Day 3
|
95.4 % of Oxygen Saturation
Standard Deviation 3.2
|
94.5 % of Oxygen Saturation
Standard Deviation 4.7
|
|
Oxygenation
Day 7
|
96.2 % of Oxygen Saturation
Standard Deviation 2.2
|
95.8 % of Oxygen Saturation
Standard Deviation 5.7
|
|
Oxygenation
Day 10
|
96.7 % of Oxygen Saturation
Standard Deviation 2.5
|
96.7 % of Oxygen Saturation
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Day 0, 3, 7, and 10Number of participants who returned to room air
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Return To Room Air (RTRA)
Day 0
|
15 Participants
|
4 Participants
|
|
Return To Room Air (RTRA)
Day 3
|
13 Participants
|
8 Participants
|
|
Return To Room Air (RTRA)
Day 7
|
11 Participants
|
7 Participants
|
|
Return To Room Air (RTRA)
Day 10
|
12 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 0, 3, 7, and Day 10Population: We had 24 participants in the treatment group and 9 in the placebo who had D-dimer values available.
Change from baseline in D-dimer in the blood (mg/L)
Outcome measures
| Measure |
HB-adMSCs
n=24 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=9 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
D-dimer
Day 0
|
1.3 mg/L
Standard Deviation 1.4
|
2.1 mg/L
Standard Deviation 2.6
|
|
D-dimer
Day 3
|
1.2 mg/L
Standard Deviation 1.7
|
2.3 mg/L
Standard Deviation 2.8
|
|
D-dimer
Day 7
|
0.7 mg/L
Standard Deviation 0.5
|
13.6 mg/L
Standard Deviation 9.1
|
|
D-dimer
Day 10
|
6.8 mg/L
Standard Deviation 7.7
|
—
|
SECONDARY outcome
Timeframe: Day 0, 3 7, and 10Population: In the treatment arm, maximum number analyzed was 3 at Day 3 and in Placebo group maximum number analyzed was 1 at Day 3
Clinical lab evaluation of level of Myoglobin in the blood (ng/mL)
Outcome measures
| Measure |
HB-adMSCs
n=3 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=1 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Myoglobin
Day 0
|
183.0 ng/mL
Standard Deviation NA
Not enough timepoints analyzed to get a Standard Deviation (SD) value for the HB-adMSCs group.
|
21.0 ng/mL
Standard Deviation NA
Not enough timepoints analyzed to get a Standard Deviation (SD) value for the Placebo group.
|
|
Myoglobin
Day 3
|
142.3 ng/mL
Standard Deviation 155.8
|
100.0 ng/mL
Standard Deviation NA
Not enough timepoints analyzed to get a Standard Deviation (SD) value for the Placebo group.
|
|
Myoglobin
Day 7
|
21.5 ng/mL
Standard Deviation 0.7
|
—
|
|
Myoglobin
Day 10
|
50.3 ng/mL
Standard Deviation 48.2
|
—
|
SECONDARY outcome
Timeframe: Day 0, 3, 7, and 10Population: In the treatment arm, maximum number analyzed was 14 at Day 0 and in Placebo group maximum number analyzed was 5 at Day 0
Clinical lab evaluation of level of Troponin in the blood (ng/mL)
Outcome measures
| Measure |
HB-adMSCs
n=14 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=5 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Troponin
Day 0
|
0.5 ng/mL
Standard Deviation 1.8
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Troponin
Day 3
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
|
|
Troponin
Day 7
|
0.1 ng/mL
Standard Deviation 0.2
|
0.0 ng/mL
|
|
Troponin
Day 10
|
0.0 ng/mL
Standard Deviation 0.0
|
—
|
SECONDARY outcome
Timeframe: Day 0, 3, 7, and 10Population: In the treatment arm, maximum number analyzed was 19 at Day 0 and in Placebo group maximum number analyzed was 8 at Day 0.
Clinical lab evaluation of level of Creatinine Kinase (CK-MB) in the blood (ng/mL)
Outcome measures
| Measure |
HB-adMSCs
n=19 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=8 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Creatinine Kinase MB (CK-MB)
Day 3
|
3.0 ng/mL
Standard Deviation 4.6
|
2.2 ng/mL
Standard Deviation 1.2
|
|
Creatinine Kinase MB (CK-MB)
Day 0
|
2.6 ng/mL
Standard Deviation 2.6
|
2.0 ng/mL
Standard Deviation 1.1
|
|
Creatinine Kinase MB (CK-MB)
Day 7
|
3.3 ng/mL
Standard Deviation 2.9
|
2.3 ng/mL
Standard Deviation 1.4
|
|
Creatinine Kinase MB (CK-MB)
Day 10
|
3.7 ng/mL
Standard Deviation 3.9
|
1.9 ng/mL
|
SECONDARY outcome
Timeframe: Day 0, 3, 7, and 10Population: In the treatment arm, maximum number analyzed was 24 at Day 0 and in Placebo group maximum number analyzed was 7 at Day 0
Clinical lab evaluation of level of Serum Ferritin in the blood (ng/mL)
Outcome measures
| Measure |
HB-adMSCs
n=24 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=7 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Serum Ferritin
Day 0
|
420.5 ng/mL
Standard Deviation 406.0
|
423.5 ng/mL
Standard Deviation 387.9
|
|
Serum Ferritin
Day 3
|
499.6 ng/mL
Standard Deviation 424.2
|
391.2 ng/mL
Standard Deviation 324.0
|
|
Serum Ferritin
Day 7
|
753.9 ng/mL
Standard Deviation 449.4
|
361.0 ng/mL
Standard Deviation 397.8
|
|
Serum Ferritin
Day 10
|
509.0 ng/mL
Standard Deviation 384.9
|
63.2 ng/mL
|
SECONDARY outcome
Timeframe: Day 0, 3, 7, and 10Population: In the treatment arm, maximum number analyzed was 6 at Day 0 and in Placebo group maximum number analyzed was 1 at Day 0
Clinical lab evaluation of Percentage of Cells CD3-CD56+ in the blood (%)
Outcome measures
| Measure |
HB-adMSCs
n=6 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=1 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
NK Cell Surface Antigen (CD3-CD56+)
Day 0
|
66.4 % of Cells
Standard Deviation 58.5
|
6.9 % of Cells
|
|
NK Cell Surface Antigen (CD3-CD56+)
Day 3
|
—
|
320.0 % of Cells
|
|
NK Cell Surface Antigen (CD3-CD56+)
Day 7
|
21.9 % of Cells
Standard Deviation 30.3
|
—
|
SECONDARY outcome
Timeframe: Day 0, 3, 7, and 10Clinical lab evaluation of Ratio of CD4+/CD8+ Cells in the blood
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
CD4+/CD8+ Ratio
Day 0
|
2.5 Ratio
Standard Deviation 1.7
|
1.9 Ratio
Standard Deviation 0.9
|
|
CD4+/CD8+ Ratio
Day 3
|
2.5 Ratio
Standard Deviation 1.3
|
2.6 Ratio
Standard Deviation 1.7
|
|
CD4+/CD8+ Ratio
Day 7
|
2.4 Ratio
Standard Deviation 1.4
|
2.4 Ratio
Standard Deviation 1.4
|
|
CD4+/CD8+ Ratio
Day 10
|
2.4 Ratio
Standard Deviation 0.9
|
2.3 Ratio
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Day 0, 3, 7, 10, and 28 (End of Study)Change from baseline in Ordinal scale score. Scale of 1-7. A score of 1 indicates Death and 7 indicates Subject is not Hospitalized and has no Limitations on activities.
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
7-Point Ordinal Scale
7: Death - Day 7
|
4 Participants
|
0 Participants
|
|
7-Point Ordinal Scale
1: Not hospitalized, no limitations on activities - Day 0
|
1 Participants
|
1 Participants
|
|
7-Point Ordinal Scale
1: Not hospitalized, no limitations on activities - Day 3
|
3 Participants
|
3 Participants
|
|
7-Point Ordinal Scale
1: Not hospitalized, no limitations on activities - Day 7
|
3 Participants
|
5 Participants
|
|
7-Point Ordinal Scale
1: Not hospitalized, no limitations on activities - Day 10
|
6 Participants
|
5 Participants
|
|
7-Point Ordinal Scale
1: Not hospitalized, no limitations on activities - Day 28 (End of Study)
|
14 Participants
|
7 Participants
|
|
7-Point Ordinal Scale
2: Not hospitalized, limitation on activities - Day 0
|
2 Participants
|
4 Participants
|
|
7-Point Ordinal Scale
2: Not hospitalized, limitation on activities - Day 3
|
9 Participants
|
5 Participants
|
|
7-Point Ordinal Scale
2: Not hospitalized, limitation on activities - Day 7
|
14 Participants
|
7 Participants
|
|
7-Point Ordinal Scale
2: Not hospitalized, limitation on activities - Day 10
|
12 Participants
|
7 Participants
|
|
7-Point Ordinal Scale
2: Not hospitalized, limitation on activities - Day 28 (End of Study)
|
9 Participants
|
6 Participants
|
|
7-Point Ordinal Scale
3: Hospitalized, not requiring supplemental oxygen - Day 0
|
8 Participants
|
0 Participants
|
|
7-Point Ordinal Scale
3: Hospitalized, not requiring supplemental oxygen - Day 3
|
3 Participants
|
0 Participants
|
|
7-Point Ordinal Scale
3: Hospitalized, not requiring supplemental oxygen - Day 7
|
2 Participants
|
0 Participants
|
|
7-Point Ordinal Scale
3: Hospitalized, not requiring supplemental oxygen - Day 10
|
1 Participants
|
0 Participants
|
|
7-Point Ordinal Scale
3: Hospitalized, not requiring supplemental oxygen - Day 28 (End of Study)
|
0 Participants
|
0 Participants
|
|
7-Point Ordinal Scale
4: Hospitalized, requiring supplemental oxygen - Day 0
|
15 Participants
|
8 Participants
|
|
7-Point Ordinal Scale
4: Hospitalized, requiring supplemental oxygen - Day 3
|
12 Participants
|
6 Participants
|
|
7-Point Ordinal Scale
4: Hospitalized, requiring supplemental oxygen - Day 7
|
5 Participants
|
1 Participants
|
|
7-Point Ordinal Scale
4: Hospitalized, requiring supplemental oxygen - Day 10
|
4 Participants
|
0 Participants
|
|
7-Point Ordinal Scale
4: Hospitalized, requiring supplemental oxygen - Day 28 (End of Study)
|
1 Participants
|
0 Participants
|
|
7-Point Ordinal Scale
5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 0
|
6 Participants
|
2 Participants
|
|
7-Point Ordinal Scale
5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 3
|
4 Participants
|
1 Participants
|
|
7-Point Ordinal Scale
5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 7
|
5 Participants
|
1 Participants
|
|
7-Point Ordinal Scale
5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 10
|
2 Participants
|
2 Participants
|
|
7-Point Ordinal Scale
5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 28 (End of Study)
|
0 Participants
|
0 Participants
|
|
7-Point Ordinal Scale
6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 0
|
1 Participants
|
0 Participants
|
|
7-Point Ordinal Scale
6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 3
|
1 Participants
|
0 Participants
|
|
7-Point Ordinal Scale
6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 7
|
0 Participants
|
1 Participants
|
|
7-Point Ordinal Scale
6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 10
|
2 Participants
|
0 Participants
|
|
7-Point Ordinal Scale
6: Hospitalized, on invasive mechanical ventilation or - Day 28 (End of Study)
|
1 Participants
|
0 Participants
|
|
7-Point Ordinal Scale
7: Death - Day 0
|
0 Participants
|
0 Participants
|
|
7-Point Ordinal Scale
7: Death - Day 3
|
1 Participants
|
0 Participants
|
|
7-Point Ordinal Scale
7: Death - Day 10
|
6 Participants
|
1 Participants
|
|
7-Point Ordinal Scale
7: Death - Day 28 (End of Study)
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 0 and Day 28Change from baseline Computed Tomography (CT) Scan Score. A semi-quantitative CT severity scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, \< 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, \> 75% involvement. The resulting global CT score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better.
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Computed Tomography (CT) Score
Day 0
|
2.9 Score on a Scale 0-25
Standard Deviation 1.4
|
3.0 Score on a Scale 0-25
Standard Deviation 0.9
|
|
Computed Tomography (CT) Score
Day 28
|
1.2 Score on a Scale 0-25
Standard Deviation 1.6
|
1.2 Score on a Scale 0-25
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Day 0, Day 28Change from baseline in Chest X-Ray Score. Scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, \< 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, \> 75% involvement. The resulting score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better.
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Chest X-Ray Score
Day 0
|
2.9 Score on a Scale 0-25
Standard Deviation 1.6
|
2.7 Score on a Scale 0-25
Standard Deviation 0.6
|
|
Chest X-Ray Score
Day 28
|
1.7 Score on a Scale 0-25
Standard Deviation 1.6
|
1.5 Score on a Scale 0-25
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Glucose in the blood (mg/dL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Glucose
Day 7
|
175.7 mg/dL
Standard Deviation 106.4
|
165.7 mg/dL
Standard Deviation 37.5
|
|
Glucose
Screening
|
139.3 mg/dL
Standard Deviation 58.0
|
148.1 mg/dL
Standard Deviation 55.4
|
|
Glucose
Day 0
|
153.4 mg/dL
Standard Deviation 89.0
|
165.4 mg/dL
Standard Deviation 52.5
|
|
Glucose
Day 3
|
148.2 mg/dL
Standard Deviation 74.8
|
145.6 mg/dL
Standard Deviation 58.7
|
|
Glucose
Day 10
|
166.9 mg/dL
Standard Deviation 110.0
|
129.8 mg/dL
Standard Deviation 74.4
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Blood Urea Nitrogen (BUN) (mg/dL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Blood Urea Nitrogen (BUN)
Screening
|
19.7 mg/dL
Standard Deviation 14.3
|
14.3 mg/dL
Standard Deviation 5.8
|
|
Blood Urea Nitrogen (BUN)
Day 0
|
22.9 mg/dL
Standard Deviation 17.4
|
15.6 mg/dL
Standard Deviation 4.8
|
|
Blood Urea Nitrogen (BUN)
Day 3
|
24.0 mg/dL
Standard Deviation 18.5
|
12.7 mg/dL
Standard Deviation 4.4
|
|
Blood Urea Nitrogen (BUN)
Day 7
|
28.4 mg/dL
Standard Deviation 28.1
|
19.9 mg/dL
Standard Deviation 7.8
|
|
Blood Urea Nitrogen (BUN)
Day 10
|
19.8 mg/dL
Standard Deviation 12.1
|
14.9 mg/dL
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Population: Estimated glomerular filtration rate (eGFR) if Non-African American
Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) if Non-African American in the blood (mL/min/1.73)
Outcome measures
| Measure |
HB-adMSCs
n=22 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=10 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR) if Non-African American
Screening
|
230.3 mL/min/1.73
Standard Deviation 270.1
|
127.1 mL/min/1.73
Standard Deviation 30.7
|
|
Estimated Glomerular Filtration Rate (eGFR) if Non-African American
Day 0
|
143.0 mL/min/1.73
Standard Deviation 103.8
|
117.0 mL/min/1.73
Standard Deviation 33.9
|
|
Estimated Glomerular Filtration Rate (eGFR) if Non-African American
Day 3
|
113.4 mL/min/1.73
Standard Deviation 25.2
|
112.8 mL/min/1.73
Standard Deviation 22.4
|
|
Estimated Glomerular Filtration Rate (eGFR) if Non-African American
Day 7
|
102.8 mL/min/1.73
Standard Deviation 44.8
|
109.6 mL/min/1.73
Standard Deviation 16.5
|
|
Estimated Glomerular Filtration Rate (eGFR) if Non-African American
Day 10
|
107.0 mL/min/1.73
Standard Deviation 36.0
|
108.0 mL/min/1.73
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Population: In the treatment arm, maximum number analyzed was 7 at Day 0 and in Placebo group maximum number analyzed was 2 at Day 10
Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) If African American in the blood (mL/min/1.73)
Outcome measures
| Measure |
HB-adMSCs
n=7 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=2 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR) if African American
Screening
|
106.4 mL/min/1.73
Standard Deviation 37.3
|
—
|
|
Estimated Glomerular Filtration Rate (eGFR) if African American
Day 0
|
74.3 mL/min/1.73
Standard Deviation 42.7
|
107.0 mL/min/1.73
|
|
Estimated Glomerular Filtration Rate (eGFR) if African American
Day 3
|
98.2 mL/min/1.73
Standard Deviation 58.9
|
97.0 mL/min/1.73
|
|
Estimated Glomerular Filtration Rate (eGFR) if African American
Day 7
|
78.8 mL/min/1.73
Standard Deviation 50.1
|
107.0 mL/min/1.73
|
|
Estimated Glomerular Filtration Rate (eGFR) if African American
Day 10
|
78.4 mL/min/1.73
Standard Deviation 45.7
|
94.5 mL/min/1.73
Standard Deviation 26.2
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of BUN/Creatinine Ratio in the blood
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
BUN/Creatinine Ratio
Screening
|
18.1 Ratio
Standard Deviation 6.6
|
18.9 Ratio
Standard Deviation 2.7
|
|
BUN/Creatinine Ratio
Day 0
|
22.9 Ratio
Standard Deviation 11.0
|
20.7 Ratio
Standard Deviation 4.7
|
|
BUN/Creatinine Ratio
Day 3
|
22.4 Ratio
Standard Deviation 6.9
|
19.2 Ratio
Standard Deviation 5.8
|
|
BUN/Creatinine Ratio
Day 7
|
30.3 Ratio
Standard Deviation 24.6
|
26.1 Ratio
Standard Deviation 8.0
|
|
BUN/Creatinine Ratio
Day 10
|
20.2 Ratio
Standard Deviation 7.9
|
18.4 Ratio
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Sodium in the blood (mmol/L)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Sodium
Screening
|
137.8 mmol/L
Standard Deviation 3.5
|
136.9 mmol/L
Standard Deviation 3.5
|
|
Sodium
Day 0
|
139.4 mmol/L
Standard Deviation 3.6
|
137.9 mmol/L
Standard Deviation 3.5
|
|
Sodium
Day 3
|
140.6 mmol/L
Standard Deviation 3.3
|
140.0 mmol/L
Standard Deviation 2.8
|
|
Sodium
Day 7
|
132.3 mmol/L
Standard Deviation 29.6
|
139.3 mmol/L
Standard Deviation 3.2
|
|
Sodium
Day 10
|
139.2 mmol/L
Standard Deviation 4.4
|
141.2 mmol/L
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Potassium in the blood (mmol/L)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Potassium
Screening
|
4.2 mmol/L
Standard Deviation 0.5
|
4.2 mmol/L
Standard Deviation 0.5
|
|
Potassium
Day 0
|
4.1 mmol/L
Standard Deviation 0.5
|
4.1 mmol/L
Standard Deviation 0.6
|
|
Potassium
Day 3
|
3.9 mmol/L
Standard Deviation 0.6
|
4.0 mmol/L
Standard Deviation 0.3
|
|
Potassium
Day 7
|
4.3 mmol/L
Standard Deviation 1.3
|
4.5 mmol/L
Standard Deviation 0.5
|
|
Potassium
Day 10
|
4.5 mmol/L
Standard Deviation 1.0
|
4.2 mmol/L
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Chloride in the blood (mmol/L)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Chloride
Screening
|
103.0 mmol/L
Standard Deviation 3.9
|
102.2 mmol/L
Standard Deviation 2.9
|
|
Chloride
Day 0
|
103.3 mmol/L
Standard Deviation 3.7
|
101.0 mmol/L
Standard Deviation 4.4
|
|
Chloride
Day 3
|
103.3 mmol/L
Standard Deviation 4.2
|
101.8 mmol/L
Standard Deviation 4.1
|
|
Chloride
Day 7
|
102.5 mmol/L
Standard Deviation 5.5
|
102.1 mmol/L
Standard Deviation 2.1
|
|
Chloride
Day 10
|
101.9 mmol/L
Standard Deviation 4.6
|
104.1 mmol/L
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of total level of Carbon Dioxide in the blood (mmol/L)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Carbon Dioxide Total
Screening
|
25.2 mmol/L
Standard Deviation 4.5
|
25.4 mmol/L
Standard Deviation 3.1
|
|
Carbon Dioxide Total
Day 0
|
24.1 mmol/L
Standard Deviation 4.8
|
25.3 mmol/L
Standard Deviation 4.4
|
|
Carbon Dioxide Total
Day 3
|
24.6 mmol/L
Standard Deviation 4.0
|
25.3 mmol/L
Standard Deviation 2.8
|
|
Carbon Dioxide Total
Day 7
|
23.8 mmol/L
Standard Deviation 3.5
|
26.3 mmol/L
Standard Deviation 2.8
|
|
Carbon Dioxide Total
Day 10
|
21.9 mmol/L
Standard Deviation 3.8
|
25.4 mmol/L
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Calcium in the blood (mg/dL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Calcium
Screening
|
8.6 mg/dL
Standard Deviation 0.5
|
8.7 mg/dL
Standard Deviation 0.6
|
|
Calcium
Day 0
|
8.4 mg/dL
Standard Deviation 0.5
|
8.3 mg/dL
Standard Deviation 0.7
|
|
Calcium
Day 3
|
8.3 mg/dL
Standard Deviation 0.7
|
8.3 mg/dL
Standard Deviation 0.8
|
|
Calcium
Day 7
|
8.4 mg/dL
Standard Deviation 1.1
|
8.7 mg/dL
Standard Deviation 0.9
|
|
Calcium
Day 10
|
8.6 mg/dL
Standard Deviation 1.1
|
9.1 mg/dL
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of total level of Protein in the blood (g/dL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Protein Total
Screening
|
6.2 g/dL
Standard Deviation 0.9
|
6.5 g/dL
Standard Deviation 0.8
|
|
Protein Total
Day 0
|
5.9 g/dL
Standard Deviation 0.7
|
6.0 g/dL
Standard Deviation 0.8
|
|
Protein Total
Day 3
|
5.7 g/dL
Standard Deviation 0.8
|
6.0 g/dL
Standard Deviation 0.7
|
|
Protein Total
Day 7
|
5.6 g/dL
Standard Deviation 1.1
|
6.1 g/dL
Standard Deviation 0.6
|
|
Protein Total
Day 10
|
6.0 g/dL
Standard Deviation 1.1
|
6.3 g/dL
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Albumin in the blood (g/dL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Albumin
Screening
|
3.4 g/dL
Standard Deviation 0.5
|
3.6 g/dL
Standard Deviation 0.6
|
|
Albumin
Day 0
|
3.4 g/dL
Standard Deviation 0.5
|
3.5 g/dL
Standard Deviation 0.6
|
|
Albumin
Day 3
|
3.2 g/dL
Standard Deviation 0.7
|
3.4 g/dL
Standard Deviation 0.6
|
|
Albumin
Day 7
|
3.2 g/dL
Standard Deviation 0.8
|
3.5 g/dL
Standard Deviation 0.8
|
|
Albumin
Day 10
|
3.4 g/dL
Standard Deviation 0.8
|
3.9 g/dL
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of the total level of Globulin in the blood (g/dL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Globulin Total
Screening
|
2.8 g/dL
Standard Deviation 0.6
|
2.9 g/dL
Standard Deviation 0.5
|
|
Globulin Total
Day 0
|
2.6 g/dL
Standard Deviation 0.5
|
2.6 g/dL
Standard Deviation 0.4
|
|
Globulin Total
Day 3
|
2.5 g/dL
Standard Deviation 0.5
|
2.6 g/dL
Standard Deviation 0.5
|
|
Globulin Total
Day 7
|
2.5 g/dL
Standard Deviation 0.5
|
2.6 g/dL
Standard Deviation 0.4
|
|
Globulin Total
Day 10
|
2.6 g/dL
Standard Deviation 0.6
|
2.3 g/dL
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Population: In the treatment arm, maximum number analyzed was 14 (at Day 7) and in Placebo group maximum number analyzed was 8 at (Day 10). These were the largest N collected.
Clinical lab evaluation of Albumin/Globulin (A/G) Ratio in the blood
Outcome measures
| Measure |
HB-adMSCs
n=14 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=8 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Albumin/Globulin (A/G) Ratio
Day 0
|
1.4 Ratio
Standard Deviation 0.3
|
1.3 Ratio
Standard Deviation 0.3
|
|
Albumin/Globulin (A/G) Ratio
Day 3
|
1.5 Ratio
Standard Deviation 0.4
|
1.5 Ratio
Standard Deviation 0.4
|
|
Albumin/Globulin (A/G) Ratio
Day 7
|
1.4 Ratio
Standard Deviation 0.3
|
1.4 Ratio
Standard Deviation 0.4
|
|
Albumin/Globulin (A/G) Ratio
Day 10
|
1.3 Ratio
Standard Deviation 0.4
|
1.7 Ratio
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of the total level of Bilirubin in the blood (mg/dL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Bilirubin Total
Screening
|
0.6 mg/dL
Standard Deviation 0.4
|
0.5 mg/dL
Standard Deviation 0.2
|
|
Bilirubin Total
Day 0
|
0.4 mg/dL
Standard Deviation 0.2
|
0.4 mg/dL
Standard Deviation 0.3
|
|
Bilirubin Total
Day 3
|
0.7 mg/dL
Standard Deviation 0.8
|
0.4 mg/dL
Standard Deviation 0.2
|
|
Bilirubin Total
Day 7
|
0.5 mg/dL
Standard Deviation 0.2
|
0.5 mg/dL
Standard Deviation 0.4
|
|
Bilirubin Total
Day 10
|
0.5 mg/dL
Standard Deviation 0.2
|
0.6 mg/dL
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Alkaline Phosphatase in the blood (IU/L)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Alkaline Phosphatase
Day 0
|
84.9 IU/L
Standard Deviation 35.3
|
66.5 IU/L
Standard Deviation 21.6
|
|
Alkaline Phosphatase
Day 3
|
101.8 IU/L
Standard Deviation 71.1
|
67.7 IU/L
Standard Deviation 22.1
|
|
Alkaline Phosphatase
Day 7
|
83.9 IU/L
Standard Deviation 35.0
|
86.6 IU/L
Standard Deviation 15.2
|
|
Alkaline Phosphatase
Screening
|
85.5 IU/L
Standard Deviation 37.2
|
71.9 IU/L
Standard Deviation 19.8
|
|
Alkaline Phosphatase
Day 10
|
94.2 IU/L
Standard Deviation 47.3
|
79.1 IU/L
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Aspartate aminotransferase (SGOT) in the blood (IU/L)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Aspartate Aminotransferase (SGOT)
Screening
|
41.9 IU/L
Standard Deviation 33.3
|
41.1 IU/L
Standard Deviation 28.2
|
|
Aspartate Aminotransferase (SGOT)
Day 0
|
30.0 IU/L
Standard Deviation 18.3
|
38.2 IU/L
Standard Deviation 26.4
|
|
Aspartate Aminotransferase (SGOT)
Day 3
|
69.7 IU/L
Standard Deviation 117.3
|
47.3 IU/L
Standard Deviation 33.9
|
|
Aspartate Aminotransferase (SGOT)
Day 7
|
41.4 IU/L
Standard Deviation 52.7
|
46.1 IU/L
Standard Deviation 32.8
|
|
Aspartate Aminotransferase (SGOT)
Day 10
|
36.6 IU/L
Standard Deviation 20.0
|
27.6 IU/L
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Alanine aminotransferase (SGPT) in the blood (IU/L)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Alanine Aminotransferase (SGPT)
Screening
|
50.8 IU/L
Standard Deviation 58.3
|
77.0 IU/L
Standard Deviation 124.5
|
|
Alanine Aminotransferase (SGPT)
Day 0
|
38.5 IU/L
Standard Deviation 39.7
|
57.2 IU/L
Standard Deviation 38.6
|
|
Alanine Aminotransferase (SGPT)
Day 3
|
68.0 IU/L
Standard Deviation 78.8
|
107.0 IU/L
Standard Deviation 122.3
|
|
Alanine Aminotransferase (SGPT)
Day 7
|
46.4 IU/L
Standard Deviation 39.7
|
108.7 IU/L
Standard Deviation 106.2
|
|
Alanine Aminotransferase (SGPT)
Day 10
|
42.2 IU/L
Standard Deviation 29.3
|
70.8 IU/L
Standard Deviation 83.4
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of count of White Blood Cells (WBCs) in the blood (x10\^3/uL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
White Blood Count (WBC)
Screening
|
8.4 cells x 10^3/uL
Standard Deviation 4.0
|
8.6 cells x 10^3/uL
Standard Deviation 5.0
|
|
White Blood Count (WBC)
Day 0
|
11.3 cells x 10^3/uL
Standard Deviation 10.5
|
10.3 cells x 10^3/uL
Standard Deviation 3.6
|
|
White Blood Count (WBC)
Day 3
|
13.5 cells x 10^3/uL
Standard Deviation 11.3
|
13.8 cells x 10^3/uL
Standard Deviation 8.7
|
|
White Blood Count (WBC)
Day 7
|
12.1 cells x 10^3/uL
Standard Deviation 5.8
|
12.7 cells x 10^3/uL
Standard Deviation 5.5
|
|
White Blood Count (WBC)
Day 10
|
10.4 cells x 10^3/uL
Standard Deviation 5.0
|
11.4 cells x 10^3/uL
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of Red Blood Cell (RBC) Count in the blood (cells x 10\^3/uL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Red Blood Cell (RBC) Count
Screening
|
4.2 cells x 10^3/uL
Standard Deviation 0.7
|
4.5 cells x 10^3/uL
Standard Deviation 0.6
|
|
Red Blood Cell (RBC) Count
Day 0
|
4.2 cells x 10^3/uL
Standard Deviation 0.8
|
4.5 cells x 10^3/uL
Standard Deviation 1.0
|
|
Red Blood Cell (RBC) Count
Day 3
|
4.1 cells x 10^3/uL
Standard Deviation 0.9
|
4.5 cells x 10^3/uL
Standard Deviation 1.0
|
|
Red Blood Cell (RBC) Count
Day 7
|
3.9 cells x 10^3/uL
Standard Deviation 0.8
|
4.6 cells x 10^3/uL
Standard Deviation 0.8
|
|
Red Blood Cell (RBC) Count
Day 10
|
3.9 cells x 10^3/uL
Standard Deviation 0.9
|
4.3 cells x 10^3/uL
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Hemoglobin in the blood (g/dL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Hemoglobin
Screening
|
12.0 g/dL
Standard Deviation 2.5
|
12.8 g/dL
Standard Deviation 2.3
|
|
Hemoglobin
Day 0
|
11.9 g/dL
Standard Deviation 2.5
|
12.5 g/dL
Standard Deviation 3.1
|
|
Hemoglobin
Day 3
|
11.6 g/dL
Standard Deviation 2.7
|
12.1 g/dL
Standard Deviation 2.0
|
|
Hemoglobin
Day 7
|
10.8 g/dL
Standard Deviation 2.2
|
13.4 g/dL
Standard Deviation 2.8
|
|
Hemoglobin
Day 10
|
11.1 g/dL
Standard Deviation 2.8
|
12.4 g/dL
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Hematocrit in the blood (%)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Hematocrit
Screening
|
37.3 % of RBCs
Standard Deviation 6.7
|
39.5 % of RBCs
Standard Deviation 6.3
|
|
Hematocrit
Day 0
|
37.3 % of RBCs
Standard Deviation 6.8
|
38.8 % of RBCs
Standard Deviation 8.7
|
|
Hematocrit
Day 3
|
36.0 % of RBCs
Standard Deviation 7.7
|
38.0 % of RBCs
Standard Deviation 6.3
|
|
Hematocrit
Day 7
|
33.2 % of RBCs
Standard Deviation 6.3
|
39.6 % of RBCs
Standard Deviation 7.8
|
|
Hematocrit
Day 10
|
34.6 % of RBCs
Standard Deviation 8.3
|
36.7 % of RBCs
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Mean Corpuscular Volume (MCV) in the blood (fL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Mean Corpuscular Volume (MCV)
Screening
|
88.8 fL
Standard Deviation 9.7
|
86.9 fL
Standard Deviation 4.4
|
|
Mean Corpuscular Volume (MCV)
Day 0
|
89.6 fL
Standard Deviation 8.9
|
86.8 fL
Standard Deviation 6.0
|
|
Mean Corpuscular Volume (MCV)
Day 3
|
89.4 fL
Standard Deviation 9.8
|
85.8 fL
Standard Deviation 6.2
|
|
Mean Corpuscular Volume (MCV)
Day 7
|
86.8 fL
Standard Deviation 9.5
|
85.2 fL
Standard Deviation 3.2
|
|
Mean Corpuscular Volume (MCV)
Day 10
|
89.8 fL
Standard Deviation 8.7
|
85.0 fL
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Mean Corpuscular Hemoglobin (MCH) in the blood (pg)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Mean Corpuscular Hemoglobin (MCH)
Screening
|
28.5 pg
Standard Deviation 3.9
|
45.4 pg
Standard Deviation 67.6
|
|
Mean Corpuscular Hemoglobin (MCH)
Day 0
|
28.6 pg
Standard Deviation 3.8
|
27.8 pg
Standard Deviation 2.5
|
|
Mean Corpuscular Hemoglobin (MCH)
Day 3
|
28.8 pg
Standard Deviation 3.9
|
27.4 pg
Standard Deviation 2.9
|
|
Mean Corpuscular Hemoglobin (MCH)
Day 7
|
28.3 pg
Standard Deviation 3.9
|
28.7 pg
Standard Deviation 1.5
|
|
Mean Corpuscular Hemoglobin (MCH)
Day 10
|
28.7 pg
Standard Deviation 3.1
|
28.7 pg
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of Mean Corpuscular Hemoglobin Concentration (MCHC) in the blood (g/dL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Mean Corpuscular Hemoglobin Concentration (MCHC)
Screening
|
32.0 g/dL
Standard Deviation 1.8
|
32.3 g/dL
Standard Deviation 1.6
|
|
Mean Corpuscular Hemoglobin Concentration (MCHC)
Day 0
|
31.9 g/dL
Standard Deviation 2.0
|
32.0 g/dL
Standard Deviation 1.8
|
|
Mean Corpuscular Hemoglobin Concentration (MCHC)
Day 3
|
32.1 g/dL
Standard Deviation 1.9
|
31.8 g/dL
Standard Deviation 1.9
|
|
Mean Corpuscular Hemoglobin Concentration (MCHC)
Day 7
|
32.6 g/dL
Standard Deviation 2.1
|
33.6 g/dL
Standard Deviation 1.2
|
|
Mean Corpuscular Hemoglobin Concentration (MCHC)
Day 10
|
31.9 g/dL
Standard Deviation 2.0
|
33.7 g/dL
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of Red Cell Distribution Width (RDW) in the blood (%)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Red Cell Distribution Width (RDW)
Day 0
|
18.8 Red Cell Distribution Width %
Standard Deviation 23.5
|
14.1 Red Cell Distribution Width %
Standard Deviation 1.5
|
|
Red Cell Distribution Width (RDW)
Day 3
|
15.3 Red Cell Distribution Width %
Standard Deviation 4.8
|
14.3 Red Cell Distribution Width %
Standard Deviation 2.1
|
|
Red Cell Distribution Width (RDW)
Day 7
|
15.5 Red Cell Distribution Width %
Standard Deviation 4.5
|
13.7 Red Cell Distribution Width %
Standard Deviation 0.9
|
|
Red Cell Distribution Width (RDW)
Screening
|
14.4 Red Cell Distribution Width %
Standard Deviation 1.9
|
13.9 Red Cell Distribution Width %
Standard Deviation 1.4
|
|
Red Cell Distribution Width (RDW)
Day 10
|
14.9 Red Cell Distribution Width %
Standard Deviation 2.1
|
14.3 Red Cell Distribution Width %
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Platelets in the blood (cells x10\^3/uL)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Platelets
Screening
|
232.4 cells x 10^3/uL
Standard Deviation 102.9
|
282.1 cells x 10^3/uL
Standard Deviation 122.8
|
|
Platelets
Day 0
|
237.5 cells x 10^3/uL
Standard Deviation 98.8
|
304.8 cells x 10^3/uL
Standard Deviation 101.1
|
|
Platelets
Day 3
|
258.2 cells x 10^3/uL
Standard Deviation 115.7
|
295.8 cells x 10^3/uL
Standard Deviation 109.0
|
|
Platelets
Day 7
|
273.1 cells x 10^3/uL
Standard Deviation 119.6
|
323.1 cells x 10^3/uL
Standard Deviation 101.2
|
|
Platelets
Day 10
|
245.2 cells x 10^3/uL
Standard Deviation 110.5
|
303.8 cells x 10^3/uL
Standard Deviation 86.5
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Neutrophils in the blood (%)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Neutrophils
Screening
|
78.3 % of Neutrophils
Standard Deviation 14.6
|
75.8 % of Neutrophils
Standard Deviation 16.1
|
|
Neutrophils
Day 0
|
79.4 % of Neutrophils
Standard Deviation 15.4
|
80.7 % of Neutrophils
Standard Deviation 11.3
|
|
Neutrophils
Day 3
|
77.0 % of Neutrophils
Standard Deviation 15.3
|
75.3 % of Neutrophils
Standard Deviation 15.9
|
|
Neutrophils
Day 7
|
73.5 % of Neutrophils
Standard Deviation 15.6
|
75.7 % of Neutrophils
Standard Deviation 16.6
|
|
Neutrophils
Day 10
|
75.1 % of Neutrophils
Standard Deviation 13.3
|
66.2 % of Neutrophils
Standard Deviation 17.2
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Lymphocytes in the blood (%)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Lymphocytes
Screening
|
14.4 Percentage of Lymphocytes (%)
Standard Deviation 11.4
|
16.0 Percentage of Lymphocytes (%)
Standard Deviation 11.1
|
|
Lymphocytes
Day 0
|
11.3 Percentage of Lymphocytes (%)
Standard Deviation 8.2
|
12.1 Percentage of Lymphocytes (%)
Standard Deviation 7.9
|
|
Lymphocytes
Day 3
|
14.5 Percentage of Lymphocytes (%)
Standard Deviation 13.9
|
17.2 Percentage of Lymphocytes (%)
Standard Deviation 12.7
|
|
Lymphocytes
Day 7
|
17.4 Percentage of Lymphocytes (%)
Standard Deviation 13.3
|
16.8 Percentage of Lymphocytes (%)
Standard Deviation 13.5
|
|
Lymphocytes
Day 10
|
17.0 Percentage of Lymphocytes (%)
Standard Deviation 11.8
|
25.7 Percentage of Lymphocytes (%)
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Monocytes in the blood (%)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Monocytes
Screening
|
5.7 % of Monocytes
Standard Deviation 3.3
|
5.4 % of Monocytes
Standard Deviation 2.7
|
|
Monocytes
Day 0
|
5.4 % of Monocytes
Standard Deviation 3.6
|
4.9 % of Monocytes
Standard Deviation 2.2
|
|
Monocytes
Day 3
|
5.4 % of Monocytes
Standard Deviation 2.9
|
5.8 % of Monocytes
Standard Deviation 4.0
|
|
Monocytes
Day 7
|
5.4 % of Monocytes
Standard Deviation 3.1
|
5.5 % of Monocytes
Standard Deviation 4.8
|
|
Monocytes
Day 10
|
5.2 % of Monocytes
Standard Deviation 3.6
|
6.5 % of Monocytes
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Eosinophils n the blood (%)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Eosinophils
Screening
|
1.1 % of Eosinophils
Standard Deviation 3.1
|
0.1 % of Eosinophils
Standard Deviation 0.5
|
|
Eosinophils
Day 0
|
0.2 % of Eosinophils
Standard Deviation 0.5
|
0.3 % of Eosinophils
Standard Deviation 0.5
|
|
Eosinophils
Day 3
|
0.2 % of Eosinophils
Standard Deviation 0.6
|
0.8 % of Eosinophils
Standard Deviation 1.4
|
|
Eosinophils
Day 7
|
2.5 % of Eosinophils
Standard Deviation 9.2
|
0.7 % of Eosinophils
Standard Deviation 1.0
|
|
Eosinophils
Day 10
|
1.1 % of Eosinophils
Standard Deviation 1.4
|
1.0 % of Eosinophils
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7 and 10Clinical lab evaluation of level of Basophils in the blood (%)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Basophils
Screening
|
0.3 % of Basophils
Standard Deviation 0.4
|
0.1 % of Basophils
Standard Deviation 0.2
|
|
Basophils
Day 0
|
0.1 % of Basophils
Standard Deviation 0.4
|
0.1 % of Basophils
Standard Deviation 0.3
|
|
Basophils
Day 3
|
0.2 % of Basophils
Standard Deviation 0.3
|
0.0 % of Basophils
Standard Deviation 0.0
|
|
Basophils
Day 7
|
0.4 % of Basophils
Standard Deviation 0.7
|
0.8 % of Basophils
Standard Deviation 0.9
|
|
Basophils
Day 10
|
0.4 % of Basophils
Standard Deviation 0.9
|
0.2 % of Basophils
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Population: In the treatment arm, maximum number analyzed was 21 at Day screening and in Placebo group maximum number analyzed was 10 at Screening. These were the largest N collected
Clinical lab evaluation of level of Absolute Neutrophils in the blood (cells x10\^3/uL)
Outcome measures
| Measure |
HB-adMSCs
n=21 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=10 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Absolute Neutrophils
Screening
|
7.0 cells x 10^3/uL
Standard Deviation 3.8
|
7.5 cells x 10^3/uL
Standard Deviation 4.2
|
|
Absolute Neutrophils
Day 0
|
9.7 cells x 10^3/uL
Standard Deviation 10.3
|
7.6 cells x 10^3/uL
Standard Deviation 3.4
|
|
Absolute Neutrophils
Day 3
|
15.4 cells x 10^3/uL
Standard Deviation 15.6
|
13.6 cells x 10^3/uL
Standard Deviation 11.5
|
|
Absolute Neutrophils
Day 7
|
7.4 cells x 10^3/uL
Standard Deviation 4.7
|
—
|
|
Absolute Neutrophils
Day 10
|
5.3 cells x 10^3/uL
Standard Deviation 4.2
|
—
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Population: In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 11 at screening. These were the largest N collected for this outcome.
Clinical lab evaluation of level of Absolute Lymphocytes in the blood (cells x10\^3/uL)
Outcome measures
| Measure |
HB-adMSCs
n=21 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=11 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Absolute Lymphocytes
Screening
|
1.0 cells x10^3/uL
Standard Deviation 0.6
|
1.1 cells x10^3/uL
Standard Deviation 1.1
|
|
Absolute Lymphocytes
Day 0
|
1.0 cells x10^3/uL
Standard Deviation 0.6
|
1.4 cells x10^3/uL
Standard Deviation 1.1
|
|
Absolute Lymphocytes
Day 3
|
1.0 cells x10^3/uL
Standard Deviation 0.7
|
1.9 cells x10^3/uL
Standard Deviation 1.4
|
|
Absolute Lymphocytes
Day 7
|
0.8 cells x10^3/uL
Standard Deviation 0.3
|
—
|
|
Absolute Lymphocytes
Day 10
|
261.1 cells x10^3/uL
Standard Deviation 580.8
|
2184.0 cells x10^3/uL
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Population: In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 10 at screening.These were the largest N for which data for Absolute Monocytes was collected
Clinical lab evaluation of level of Absolute Monocytes in the blood (cells x10\^3/uL)
Outcome measures
| Measure |
HB-adMSCs
n=21 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=10 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Absolute Monocytes
Screening
|
0.4 cells x10^3/uL
Standard Deviation 0.3
|
0.5 cells x10^3/uL
Standard Deviation 0.4
|
|
Absolute Monocytes
Day 0
|
1.1 cells x10^3/uL
Standard Deviation 2.5
|
0.5 cells x10^3/uL
Standard Deviation 0.4
|
|
Absolute Monocytes
Day 3
|
0.7 cells x10^3/uL
Standard Deviation 0.5
|
0.8 cells x10^3/uL
Standard Deviation 0.4
|
|
Absolute Monocytes
Day 7
|
0.6 cells x10^3/uL
Standard Deviation 0.6
|
—
|
|
Absolute Monocytes
Day 10
|
0.6 cells x10^3/uL
Standard Deviation 0.4
|
—
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Population: In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 10 at screening.These were the largest N for which data for Absolute Eosinophils was collected
Clinical lab evaluation of level of Absolute Eosinophils in the blood (cells x10\^3/uL)
Outcome measures
| Measure |
HB-adMSCs
n=21 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=10 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Absolute Eosinophils
Screening
|
0.1 cells x10^3/uL
Standard Deviation 0.3
|
0.0 cells x10^3/uL
Standard Deviation 0.0
|
|
Absolute Eosinophils
Day 0
|
0.0 cells x10^3/uL
Standard Deviation 0.0
|
0.0 cells x10^3/uL
Standard Deviation 0.0
|
|
Absolute Eosinophils
Day 3
|
0.0 cells x10^3/uL
Standard Deviation 0.0
|
0.1 cells x10^3/uL
Standard Deviation 0.2
|
|
Absolute Eosinophils
Day 7
|
0.0 cells x10^3/uL
Standard Deviation 0.1
|
—
|
|
Absolute Eosinophils
Day 10
|
0.1 cells x10^3/uL
Standard Deviation 0.1
|
—
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Population: In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 10 at screening.These were the largest N for which data for Absolute Basophils was collected
Clinical lab evaluation of level of Absolute Basophils in the blood (cells x10\^3/uL)
Outcome measures
| Measure |
HB-adMSCs
n=21 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=10 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Absolute Basophils
Screening
|
0.0 cells x10^3/uL
Standard Deviation 0.0
|
0.0 cells x10^3/uL
Standard Deviation 0.0
|
|
Absolute Basophils
Day 0
|
0.0 cells x10^3/uL
Standard Deviation 0.0
|
0.0 cells x10^3/uL
Standard Deviation 0.0
|
|
Absolute Basophils
Day 3
|
0.0 cells x10^3/uL
Standard Deviation 0.0
|
0.0 cells x10^3/uL
Standard Deviation 0.0
|
|
Absolute Basophils
Day 7
|
0.0 cells x10^3/uL
Standard Deviation 0.0
|
—
|
|
Absolute Basophils
Day 10
|
0.0 cells x10^3/uL
Standard Deviation 0.0
|
—
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Population: In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 9 at screening. These were the largest N for which data for was collected for Immature granulocytes
Clinical lab evaluation of level of Immature Granulocytes in the blood (%)
Outcome measures
| Measure |
HB-adMSCs
n=21 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=9 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Immature Granulocytes
Screening
|
0.4 % of Immature Granulocytes
Standard Deviation 0.6
|
1.2 % of Immature Granulocytes
Standard Deviation 1.1
|
|
Immature Granulocytes
Day 0
|
1.0 % of Immature Granulocytes
Standard Deviation 1.1
|
1.8 % of Immature Granulocytes
Standard Deviation 1.5
|
|
Immature Granulocytes
Day 3
|
1.6 % of Immature Granulocytes
Standard Deviation 1.7
|
1.4 % of Immature Granulocytes
Standard Deviation 1.1
|
|
Immature Granulocytes
Day 7
|
1.0 % of Immature Granulocytes
Standard Deviation 0.8
|
—
|
|
Immature Granulocytes
Day 10
|
0.6 % of Immature Granulocytes
Standard Deviation 0.5
|
—
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Population: In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 9 at screening.These were the largest N for which data was collected for Absolute Immature Granulocytes
Clinical lab evaluation of level of Absolute Immature Granulocytes in the blood (cells x10\^3/uL)
Outcome measures
| Measure |
HB-adMSCs
n=21 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=9 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Absolute Immature Granulocytes
Screening
|
0.0 cells x10^3/uL
Standard Deviation 0.0
|
0.1 cells x10^3/uL
Standard Deviation 0.2
|
|
Absolute Immature Granulocytes
Day 0
|
0.1 cells x10^3/uL
Standard Deviation 0.2
|
0.2 cells x10^3/uL
Standard Deviation 0.2
|
|
Absolute Immature Granulocytes
Day 3
|
0.2 cells x10^3/uL
Standard Deviation 0.2
|
0.3 cells x10^3/uL
Standard Deviation 0.5
|
|
Absolute Immature Granulocytes
Day 7
|
0.1 cells x10^3/uL
Standard Deviation 0.0
|
—
|
|
Absolute Immature Granulocytes
Day 10
|
0.0 cells x10^3/uL
Standard Deviation 0.1
|
—
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of International Normalized Ratio (INR)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
International Normalized Ratio (INR)
Screening
|
1.1 Ratio
Standard Deviation 0.1
|
1.1 Ratio
Standard Deviation 0.1
|
|
International Normalized Ratio (INR)
Day 0
|
1.2 Ratio
Standard Deviation 0.3
|
1.1 Ratio
Standard Deviation 0.1
|
|
International Normalized Ratio (INR)
Day 3
|
1.2 Ratio
Standard Deviation 0.3
|
1.1 Ratio
Standard Deviation 0.1
|
|
International Normalized Ratio (INR)
Day 7
|
1.2 Ratio
Standard Deviation 0.4
|
1.1 Ratio
Standard Deviation 0.1
|
|
International Normalized Ratio (INR)
Day 10
|
1.4 Ratio
Standard Deviation 0.6
|
1.1 Ratio
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Clinical lab evaluation of Prothrombin Time (seconds)
Outcome measures
| Measure |
HB-adMSCs
n=33 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Prothrombin Time (PT)
Screening
|
11.5 seconds
Standard Deviation 1.2
|
12.0 seconds
Standard Deviation 1.4
|
|
Prothrombin Time (PT)
Day 0
|
14.3 seconds
Standard Deviation 3.9
|
12.9 seconds
Standard Deviation 2.0
|
|
Prothrombin Time (PT)
Day 3
|
14.4 seconds
Standard Deviation 3.1
|
13.9 seconds
Standard Deviation 2.0
|
|
Prothrombin Time (PT)
Day 7
|
15.3 seconds
Standard Deviation 4.1
|
14.6 seconds
Standard Deviation 1.4
|
|
Prothrombin Time (PT)
Day 10
|
16.1 seconds
Standard Deviation 5.8
|
14.3 seconds
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Screening, Day 0, 3, 7, and 10Population: In the treatment arm, maximum number analyzed was 25 at screening and in Placebo group maximum number analyzed was11 at screening. These were the largest N for which data for was collected for Partial Thromboplastin time
Clinical lab evaluation of Partial Thromboplastin Time (PTT) (seconds)
Outcome measures
| Measure |
HB-adMSCs
n=25 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=11 Participants
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Partial Thromboplastin Time (PTT)
Screening
|
32.0 seconds
Standard Deviation 5.5
|
30.4 seconds
Standard Deviation 3.8
|
|
Partial Thromboplastin Time (PTT)
Day 0
|
31.6 seconds
Standard Deviation 6.6
|
29.8 seconds
Standard Deviation 4.2
|
|
Partial Thromboplastin Time (PTT)
Day 3
|
32.2 seconds
Standard Deviation 5.8
|
26.5 seconds
Standard Deviation 6.4
|
|
Partial Thromboplastin Time (PTT)
Day 7
|
31.0 seconds
Standard Deviation 6.9
|
—
|
|
Partial Thromboplastin Time (PTT)
Day 10
|
24.5 seconds
Standard Deviation 12.7
|
28.2 seconds
Standard Deviation 1.4
|
Adverse Events
HB-adMSCs
Serious events: 9 serious events
Other events: 27 other events
Deaths: 8 deaths
Placebo
Serious events: 2 serious events
Other events: 12 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
HB-adMSCs
n=33 participants at risk
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 participants at risk
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Cardiac disorders
Cardiopulmonary Failure
|
18.2%
6/33 • Number of events 6 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
13.3%
2/15 • Number of events 2 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Infections and infestations
Sepsis
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Cardiac disorders
Cardiac Arrhythmia
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
Other adverse events
| Measure |
HB-adMSCs
n=33 participants at risk
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
|
Placebo
n=15 participants at risk
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Body Aches
|
21.2%
7/33 • Number of events 9 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
26.7%
4/15 • Number of events 5 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.2%
7/33 • Number of events 7 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
13.3%
2/15 • Number of events 2 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.2%
5/33 • Number of events 5 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
20.0%
3/15 • Number of events 3 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Nervous system disorders
Headache
|
6.1%
2/33 • Number of events 4 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
20.0%
3/15 • Number of events 4 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Nervous system disorders
Hyperthermia
|
12.1%
4/33 • Number of events 6 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
13.3%
2/15 • Number of events 2 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Nervous system disorders
Fatigue
|
6.1%
2/33 • Number of events 2 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
26.7%
4/15 • Number of events 4 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Nervous system disorders
Anxiety
|
12.1%
4/33 • Number of events 4 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Cardiac disorders
Hypertension
|
6.1%
2/33 • Number of events 2 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
13.3%
2/15 • Number of events 2 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
3/33 • Number of events 3 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Cardiac disorders
Chest Discomfort
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
13.3%
2/15 • Number of events 2 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Nervous system disorders
Chills
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
6.7%
1/15 • Number of events 2 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
3/33 • Number of events 3 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Skin and subcutaneous tissue disorders
Vesicular Rash
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Nervous system disorders
Agitation
|
0.00%
0/33 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
13.3%
2/15 • Number of events 2 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Cardiac disorders
Bradycardia
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Nervous system disorders
Nausea
|
0.00%
0/33 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
6.7%
1/15 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Respiratory, thoracic and mediastinal disorders
Painful Respiration
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
6.7%
1/15 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/33 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
6.7%
1/15 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Endocrine disorders
Pancreatitis
|
0.00%
0/33 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
6.7%
1/15 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Vascular disorders
Poor Venous Access
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
6.7%
1/15 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Blood and lymphatic system disorders
ESR Raised
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Musculoskeletal and connective tissue disorders
Myofascial Neck Pain
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Nervous system disorders
Brain Natriuretic Peptide Increased
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Blood and lymphatic system disorders
Carbon Dioxide Abnormal
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Renal and urinary disorders
Urine Abnormality
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Cardiac disorders
Myocardial Necrosis Marker Increased
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Blood and lymphatic system disorders
Abnormal Blood Electrolytes
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Blood and lymphatic system disorders
Elevated WBC
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/33 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
6.7%
1/15 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Nervous system disorders
Confusional State
|
6.1%
2/33 • Number of events 2 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Gastrointestinal disorders
Dysphagia
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Nervous system disorders
Feeling Abnormal
|
0.00%
0/33 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
6.7%
1/15 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/33 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
6.7%
1/15 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Psychiatric disorders
Depression
|
0.00%
0/33 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
6.7%
1/15 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Renal and urinary disorders
Kidney Failure
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Cardiac disorders
Hypotension
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Skin and subcutaneous tissue disorders
Puncture Site Bleeding
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
3.0%
1/33 • Number of events 1 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
0.00%
0/15 • Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 serious adverse events (SAEs) reported during the study period.
|
Additional Information
Ridhima Vij, PhD
Hope Biosciences Stem Cell Research Foundation
Phone: 346-900-0340
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place