Trial Outcomes & Findings for Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects (NCT NCT02886884)
NCT ID: NCT02886884
Last Updated: 2022-05-11
Results Overview
TE-SAEs as evaluated by the investigator which may include but not limited to: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Up to one month (post infusion)
Results posted on
2022-05-11
Participant Flow
Participant milestones
| Measure |
Pilot Phase 20 Million Allogeneic hMSCs
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Pilot Phase 100 Million hMSCs
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 20 Million Allogeneic hMSCs
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 100 Million Allogeneic hMSCs
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|---|---|
|
Treatment
STARTED
|
3
|
3
|
5
|
5
|
|
Treatment
COMPLETED
|
3
|
3
|
5
|
5
|
|
Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Follow-up
STARTED
|
3
|
3
|
5
|
5
|
|
Follow-up
COMPLETED
|
3
|
3
|
5
|
4
|
|
Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Pilot Phase 20 Million Allogeneic hMSCs
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Pilot Phase 100 Million hMSCs
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 20 Million Allogeneic hMSCs
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 100 Million Allogeneic hMSCs
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|---|---|
|
Follow-up
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects
Baseline characteristics by cohort
| Measure |
Pilot Phase 20 Million Allogeneic hMSCs
n=3 Participants
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Pilot Phase 100 Million hMSCs
n=3 Participants
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 20 Million Allogeneic hMSCs
n=5 Participants
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 100 Million Allogeneic hMSCs
n=5 Participants
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
69.3 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
64.1 years
STANDARD_DEVIATION 10.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to one month (post infusion)TE-SAEs as evaluated by the investigator which may include but not limited to: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
Outcome measures
| Measure |
Pilot Phase 20 Million Allogeneic hMSCs
n=3 Participants
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Pilot Phase 100 Million hMSCs
n=3 Participants
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 20 Million Allogeneic hMSCs
n=5 Participants
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 100 Million Allogeneic hMSCs
n=5 Participants
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|---|---|
|
Number of Treatment Emergent Serious Adverse Events (TE-SAEs)
|
0 Treatment Emergent SAE
|
0 Treatment Emergent SAE
|
0 Treatment Emergent SAE
|
0 Treatment Emergent SAE
|
SECONDARY outcome
Timeframe: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365Population: Not all participants completed required blood draw at each timepoint.
Endothelial Progenitor Cell Colony Forming Units (EPC-CFU) will be assessed from blood samples
Outcome measures
| Measure |
Pilot Phase 20 Million Allogeneic hMSCs
n=3 Participants
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Pilot Phase 100 Million hMSCs
n=3 Participants
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 20 Million Allogeneic hMSCs
n=5 Participants
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 100 Million Allogeneic hMSCs
n=5 Participants
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|---|---|
|
EPC-CFU Levels
Baseline
|
2.06 Colony forming units
Standard Deviation 1.35
|
3.16 Colony forming units
Standard Deviation 1.92
|
2.37 Colony forming units
Standard Deviation 2.60
|
1.93 Colony forming units
Standard Deviation 1.38
|
|
EPC-CFU Levels
Day 3
|
3.39 Colony forming units
Standard Deviation 3.31
|
5.50 Colony forming units
Standard Deviation 3.01
|
4.37 Colony forming units
Standard Deviation 3.20
|
2.80 Colony forming units
Standard Deviation 1.72
|
|
EPC-CFU Levels
Day 7
|
9.28 Colony forming units
Standard Deviation 14.21
|
6.94 Colony forming units
Standard Deviation 8.67
|
6.07 Colony forming units
Standard Deviation 3.51
|
5.53 Colony forming units
Standard Deviation 4.78
|
|
EPC-CFU Levels
Day 14
|
6.11 Colony forming units
Standard Deviation 8.74
|
19.72 Colony forming units
Standard Deviation 17.49
|
8.23 Colony forming units
Standard Deviation 4.07
|
11.70 Colony forming units
Standard Deviation 11.58
|
|
EPC-CFU Levels
Day 28
|
7.83 Colony forming units
Standard Deviation 5.20
|
21.83 Colony forming units
Standard Deviation 2.96
|
2.50 Colony forming units
Standard Deviation 0.96
|
6.70 Colony forming units
Standard Deviation 8.27
|
|
EPC-CFU Levels
Day 90
|
9.17 Colony forming units
Standard Deviation 8.72
|
14.17 Colony forming units
Standard Deviation 2.32
|
1.90 Colony forming units
Standard Deviation 2.50
|
6.50 Colony forming units
Standard Deviation 8.16
|
|
EPC-CFU Levels
Day 180
|
8.39 Colony forming units
Standard Deviation 7.07
|
14.33 Colony forming units
Standard Deviation 3.12
|
2.45 Colony forming units
Standard Deviation 3.41
|
4.50 Colony forming units
Standard Deviation 6.46
|
|
EPC-CFU Levels
Day 365
|
6.89 Colony forming units
Standard Deviation 4.68
|
8.83 Colony forming units
Standard Deviation 3.91
|
1.04 Colony forming units
Standard Deviation 0.63
|
2.94 Colony forming units
Standard Deviation 4.25
|
SECONDARY outcome
Timeframe: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365Population: Blood samples were collected. However, due to cost and logistical reasons, the samples were not analyzed and hence no data were generated
C-Reactive Protein (CRP) levels will be assessed from blood samples and reported in mg/L
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365Population: Blood samples were collected. However, due to cost and logistical reasons, the samples were not analyzed and hence no data were generated
Circulating Angiogenic Factor levels including Vascular Endothelial Growth Factor (VEGF), Stem Cell Factor (SCF) and Stromal Cell-Derived Factor 1 (SDF-1) will be assessed from blood samples and reported in ng/mL
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365Population: Not all participants completed the brachial artery ultrasound at each timepoint.
FMD will be assessed using brachial artery ultrasound
Outcome measures
| Measure |
Pilot Phase 20 Million Allogeneic hMSCs
n=3 Participants
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Pilot Phase 100 Million hMSCs
n=3 Participants
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 20 Million Allogeneic hMSCs
n=5 Participants
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 100 Million Allogeneic hMSCs
n=5 Participants
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|---|---|
|
Flow Mediated Diameter Percentage (FMD%)
Baseline
|
2.55 Percent dilation of brachial artery
Standard Deviation 1.11
|
4.33 Percent dilation of brachial artery
Standard Deviation 2.61
|
4.55 Percent dilation of brachial artery
Standard Deviation 1.17
|
3.11 Percent dilation of brachial artery
Standard Deviation 1.92
|
|
Flow Mediated Diameter Percentage (FMD%)
Day 3
|
2.86 Percent dilation of brachial artery
Standard Deviation 1.96
|
4.76 Percent dilation of brachial artery
Standard Deviation 1.46
|
5.19 Percent dilation of brachial artery
Standard Deviation 1.33
|
4.99 Percent dilation of brachial artery
Standard Deviation 1.98
|
|
Flow Mediated Diameter Percentage (FMD%)
Day 7
|
2.97 Percent dilation of brachial artery
Standard Deviation 1.61
|
5.06 Percent dilation of brachial artery
Standard Deviation 3.70
|
4.80 Percent dilation of brachial artery
Standard Deviation 0.98
|
5.35 Percent dilation of brachial artery
Standard Deviation 2.45
|
|
Flow Mediated Diameter Percentage (FMD%)
Day 14
|
2.62 Percent dilation of brachial artery
Standard Deviation 0.53
|
5.18 Percent dilation of brachial artery
Standard Deviation 3.78
|
5.10 Percent dilation of brachial artery
Standard Deviation 1.55
|
4.94 Percent dilation of brachial artery
Standard Deviation 1.50
|
|
Flow Mediated Diameter Percentage (FMD%)
Day 28
|
2.33 Percent dilation of brachial artery
Standard Deviation 1.35
|
4.45 Percent dilation of brachial artery
Standard Deviation 3.94
|
5.67 Percent dilation of brachial artery
Standard Deviation 2.63
|
6.19 Percent dilation of brachial artery
Standard Deviation 2.53
|
|
Flow Mediated Diameter Percentage (FMD%)
Day 90
|
1.26 Percent dilation of brachial artery
Standard Deviation 0.50
|
4.78 Percent dilation of brachial artery
Standard Deviation 2.49
|
5.65 Percent dilation of brachial artery
Standard Deviation 2.89
|
5.34 Percent dilation of brachial artery
Standard Deviation 2.44
|
|
Flow Mediated Diameter Percentage (FMD%)
Day 180
|
2.90 Percent dilation of brachial artery
Standard Deviation 1.74
|
4.32 Percent dilation of brachial artery
Standard Deviation 2.47
|
5.78 Percent dilation of brachial artery
Standard Deviation 3.11
|
4.04 Percent dilation of brachial artery
Standard Deviation 1.84
|
|
Flow Mediated Diameter Percentage (FMD%)
Day 365
|
1.81 Percent dilation of brachial artery
Standard Deviation 0.24
|
4.14 Percent dilation of brachial artery
Standard Deviation 0.38
|
3.88 Percent dilation of brachial artery
Standard Deviation 1.61
|
3.65 Percent dilation of brachial artery
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365Population: Blood samples were collected. However, due to cost and logistical reasons, the samples were not analyzed and hence no data were generated
Circulating inflammatory marker levels including Interleukin (IL) -1 and IL-6 will be assessed from blood samples and reported in pg/mL
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365Population: Not all participants completed required blood draw at each timepoint.
Measured from blood samples (pg/mL)
Outcome measures
| Measure |
Pilot Phase 20 Million Allogeneic hMSCs
n=3 Participants
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Pilot Phase 100 Million hMSCs
n=3 Participants
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 20 Million Allogeneic hMSCs
n=5 Participants
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 100 Million Allogeneic hMSCs
n=5 Participants
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|---|---|
|
Tumor Necrosis Factor (TNF) Alpha Levels
Day 14
|
0.80 pg/mL
Standard Deviation 0.04
|
1.01 pg/mL
Standard Deviation 0.20
|
0.93 pg/mL
Standard Deviation 0.41
|
0.90 pg/mL
Standard Deviation 0.33
|
|
Tumor Necrosis Factor (TNF) Alpha Levels
Baseline
|
0.79 pg/mL
Standard Deviation 0.13
|
0.80 pg/mL
Standard Deviation 0.19
|
0.85 pg/mL
Standard Deviation 0.21
|
0.80 pg/mL
Standard Deviation 0.12
|
|
Tumor Necrosis Factor (TNF) Alpha Levels
Day 3
|
0.74 pg/mL
Standard Deviation 0.04
|
0.86 pg/mL
Standard Deviation 0.33
|
1.01 pg/mL
Standard Deviation 0.24
|
0.81 pg/mL
Standard Deviation 0.15
|
|
Tumor Necrosis Factor (TNF) Alpha Levels
Day 7
|
0.77 pg/mL
Standard Deviation 0.03
|
0.74 pg/mL
Standard Deviation 0.09
|
0.90 pg/mL
Standard Deviation 0.45
|
1.09 pg/mL
Standard Deviation 0.55
|
|
Tumor Necrosis Factor (TNF) Alpha Levels
Day 28
|
0.69 pg/mL
Standard Deviation 0.20
|
0.84 pg/mL
Standard Deviation 0.17
|
0.84 pg/mL
Standard Deviation 0.31
|
0.82 pg/mL
Standard Deviation 0.19
|
|
Tumor Necrosis Factor (TNF) Alpha Levels
Day 90
|
0.68 pg/mL
Standard Deviation 0.15
|
0.81 pg/mL
Standard Deviation 0.13
|
0.83 pg/mL
Standard Deviation 0.10
|
0.71 pg/mL
Standard Deviation 0.12
|
|
Tumor Necrosis Factor (TNF) Alpha Levels
Day 180
|
17.10 pg/mL
Standard Deviation NA
There is only one participant analyzed. Standard Deviation cannot be calculated.
|
0.98 pg/mL
Standard Deviation 0.51
|
0.79 pg/mL
Standard Deviation 0.25
|
0.76 pg/mL
Standard Deviation 0.10
|
|
Tumor Necrosis Factor (TNF) Alpha Levels
Day 365
|
0.83 pg/mL
Standard Deviation 0.23
|
0.95 pg/mL
Standard Deviation 0.32
|
0.76 pg/mL
Standard Deviation 0.08
|
0.81 pg/mL
Standard Deviation 0.23
|
Adverse Events
Pilot Phase 20 Million Allogeneic hMSCs
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Pilot Phase 100 Million hMSCs
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Randomized Phase 20 Million Allogeneic hMSCs
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Randomized Phase 100 Million Allogeneic hMSCs
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pilot Phase 20 Million Allogeneic hMSCs
n=3 participants at risk
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Pilot Phase 100 Million hMSCs
n=3 participants at risk
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 20 Million Allogeneic hMSCs
n=5 participants at risk
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 100 Million Allogeneic hMSCs
n=5 participants at risk
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|---|---|
|
Cardiac disorders
Chest Pain
|
33.3%
1/3 • Number of events 1 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
0.00%
0/5 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/3 • 12 months
|
33.3%
1/3 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
0.00%
0/5 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Stromal Tumor
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Infections and infestations
Abdominal Surgical Site Infection
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Pilot Phase 20 Million Allogeneic hMSCs
n=3 participants at risk
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Pilot Phase 100 Million hMSCs
n=3 participants at risk
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 20 Million Allogeneic hMSCs
n=5 participants at risk
Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Randomized Phase 100 Million Allogeneic hMSCs
n=5 participants at risk
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Elevated White Blood Cells with Neutrophilia
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/3 • 12 months
|
33.3%
1/3 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
0.00%
0/5 • 12 months
|
|
Cardiac disorders
Incomplete Right bundle branch block
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Eye disorders
Corneal Edema, Deterioration of vision
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Gastrointestinal disorders
Gastroesophogeal Reflux Disease Exacerbation
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Gastrointestinal disorders
Recurrence of Gastrointestinal bleed
|
33.3%
1/3 • Number of events 1 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
0.00%
0/5 • 12 months
|
|
Immune system disorders
Allergic Reaction to Flu shot
|
0.00%
0/3 • 12 months
|
33.3%
1/3 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
0.00%
0/5 • 12 months
|
|
Immune system disorders
Mild allergic reaction
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Infections and infestations
Genital Herpes Simplex
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
40.0%
2/5 • Number of events 2 • 12 months
|
0.00%
0/5 • 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
20.0%
1/5 • Number of events 2 • 12 months
|
0.00%
0/5 • 12 months
|
|
Infections and infestations
Viral Illness
|
0.00%
0/3 • 12 months
|
33.3%
1/3 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
0.00%
0/5 • 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
40.0%
2/5 • Number of events 2 • 12 months
|
0.00%
0/5 • 12 months
|
|
Injury, poisoning and procedural complications
Motor Vehicle Accident
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • 12 months
|
33.3%
1/3 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
0.00%
0/5 • 12 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Poor Diabetes Control
|
33.3%
1/3 • Number of events 1 • 12 months
|
0.00%
0/3 • 12 months
|
40.0%
2/5 • Number of events 2 • 12 months
|
80.0%
4/5 • Number of events 4 • 12 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Left Distal fibula fracture
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Right Shoulder Pain
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Renal and urinary disorders
Abnormal Urinalysis
|
0.00%
0/3 • 12 months
|
33.3%
1/3 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
0.00%
0/5 • 12 months
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Renal and urinary disorders
Proteinurea
|
0.00%
0/3 • 12 months
|
33.3%
1/3 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervical Intraepithelial Neoplasia 1, Mild Dysplasia
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dry Cough
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Bullous Pemphigoid
|
0.00%
0/3 • 12 months
|
33.3%
1/3 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
0.00%
0/5 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • 12 months
|
0.00%
0/3 • 12 months
|
0.00%
0/5 • 12 months
|
0.00%
0/5 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place