Trial Outcomes & Findings for AllogeneiC Human Mesenchymal Stem Cells (hMSC) in Patients With Aging FRAilTy Via IntravenoUS Delivery (NCT NCT02065245)
NCT ID: NCT02065245
Last Updated: 2021-07-14
Results Overview
Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities. * Serum chemistry: chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, glucose, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (fractionate if total \>1.5 times normal), alkaline phosphatase, albumin, * Hematology (Complete blood count): hemoglobin, hematocrit, platelets, white blood cells (WBC), WBC differential
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
65 participants
Primary outcome timeframe
One Month post infusion
Results posted on
2021-07-14
Participant Flow
Participant milestones
| Measure |
Pilot Phase - Group 1
Group 1 participants will receive Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 20 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Pilot Phase - Group 2
Group 2 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Pilot Phase - Group 3
Group 3 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Randomized Phase - Group A
Group A - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Randomized Phase - Group B
Group B - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Randomized Phase - Group C
Group C - Placebo delivered via peripheral intravenous infusion. Participants in this group have the option to receive one additional infusion of 100million allo-hMSCs/kg with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
Placebo: Placebo administered by peripheral intravenous infusion.
|
Addendum B - Antibiotic Free Cell Group
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million penicillin/streptomycin-free allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Infusion 1
STARTED
|
5
|
5
|
5
|
10
|
10
|
10
|
20
|
|
Infusion 1
COMPLETED
|
5
|
5
|
4
|
10
|
9
|
10
|
19
|
|
Infusion 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
|
Infusion 2
STARTED
|
5
|
5
|
2
|
0
|
0
|
6
|
12
|
|
Infusion 2
COMPLETED
|
5
|
5
|
2
|
0
|
0
|
6
|
11
|
|
Infusion 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Infusion 3
STARTED
|
3
|
5
|
1
|
0
|
0
|
0
|
0
|
|
Infusion 3
COMPLETED
|
2
|
4
|
1
|
0
|
0
|
0
|
0
|
|
Infusion 3
NOT COMPLETED
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Infusion 4
STARTED
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Infusion 4
COMPLETED
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Infusion 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Pilot Phase - Group 1
Group 1 participants will receive Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 20 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Pilot Phase - Group 2
Group 2 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Pilot Phase - Group 3
Group 3 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Randomized Phase - Group A
Group A - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Randomized Phase - Group B
Group B - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Randomized Phase - Group C
Group C - Placebo delivered via peripheral intravenous infusion. Participants in this group have the option to receive one additional infusion of 100million allo-hMSCs/kg with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
Placebo: Placebo administered by peripheral intravenous infusion.
|
Addendum B - Antibiotic Free Cell Group
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million penicillin/streptomycin-free allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Infusion 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Infusion 1
Death
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Infusion 2
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Infusion 3
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
AllogeneiC Human Mesenchymal Stem Cells (hMSC) in Patients With Aging FRAilTy Via IntravenoUS Delivery
Baseline characteristics by cohort
| Measure |
Pilot Phase - Group 1
n=5 Participants
Group 1 participants will receive Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 20 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Pilot Phase - Group 2
n=5 Participants
Group 2 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Pilot Phase - Group 3
n=5 Participants
Group 3 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Randomized Phase - Group A
n=10 Participants
Group A - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Randomized Phase - Group B
n=10 Participants
Group B - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Randomized Phase - Group C
n=10 Participants
Group C - Placebo delivered via peripheral intravenous infusion. Participants in this group have the option to receive one additional infusion of 100million allo-hMSCs/kg with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
Placebo: Placebo administered by peripheral intravenous infusion.
|
Addendum B - Antibiotic Free Cell Group
n=20 Participants
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million penicillin/streptomycin-free allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
78.8 years
STANDARD_DEVIATION 5.167 • n=5 Participants
|
75.8 years
STANDARD_DEVIATION 4.868 • n=7 Participants
|
79.2 years
STANDARD_DEVIATION 4.024 • n=5 Participants
|
74.6 years
STANDARD_DEVIATION 7.23 • n=4 Participants
|
75.9 years
STANDARD_DEVIATION 8.293 • n=21 Participants
|
74.7 years
STANDARD_DEVIATION 6.75 • n=8 Participants
|
72.75 years
STANDARD_DEVIATION 8.896 • n=8 Participants
|
75.015 years
STANDARD_DEVIATION 7.443 • n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
41 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
60 Participants
n=24 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
64 Participants
n=24 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: One Month post infusionPopulation: Participants were allowed to opt-in to receive additional infusion based on cohort
Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities. * Serum chemistry: chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, glucose, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (fractionate if total \>1.5 times normal), alkaline phosphatase, albumin, * Hematology (Complete blood count): hemoglobin, hematocrit, platelets, white blood cells (WBC), WBC differential
Outcome measures
| Measure |
Pilot Phase - Group 1
n=5 Participants
Group 1 participants will receive Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 20 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Pilot Phase - Group 2
n=5 Participants
Group 2 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Pilot Phase - Group 3
n=5 Participants
Group 3 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Randomized Phase - Group A
n=10 Participants
Group A - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Randomized Phase - Group B
n=10 Participants
Group B - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Randomized Phase - Group C
n=10 Participants
Group C - Placebo delivered via peripheral intravenous infusion. Participants in this group have the option to receive one additional infusion of 100million allo-hMSCs/kg with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
Placebo: Placebo administered by peripheral intravenous infusion.
|
Addendum B - Antibiotic Free Cell Group
n=20 Participants
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million penicillin/streptomycin-free allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Incidence of Any Treatment Emergent - Serious Adverse Events (TE-SAEs)
Infusion #2
|
0 Incidents
|
0 Incidents
|
0 Incidents
|
—
|
—
|
0 Incidents
|
0 Incidents
|
|
Incidence of Any Treatment Emergent - Serious Adverse Events (TE-SAEs)
Infusion #3
|
0 Incidents
|
0 Incidents
|
0 Incidents
|
—
|
—
|
—
|
—
|
|
Incidence of Any Treatment Emergent - Serious Adverse Events (TE-SAEs)
infusion #4
|
0 Incidents
|
1 Incidents
|
0 Incidents
|
—
|
—
|
—
|
—
|
|
Incidence of Any Treatment Emergent - Serious Adverse Events (TE-SAEs)
Infusion #1
|
0 Incidents
|
0 Incidents
|
0 Incidents
|
0 Incidents
|
1 Incidents
|
0 Incidents
|
0 Incidents
|
SECONDARY outcome
Timeframe: At baseline and 6 month follow-up visit.Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire measures duration of exercise-related activities (hours/week). The Duration variable can range from 0 - 399.75 hours per week. Higher scores indicate more activity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6 month follow-up visit.4-meter gait speed test measures the time (in seconds) taken to walk a distance of 4 meters. The total score has a range of 1 point - 4 points with the higher score indicating faster walk speed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6 month follow-up visit.Standard Physical Performance Battery (SPPB) Assessment has total score ranging from 0-4 with the higher score indicating better balance.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6 month follow-up visit.Change in weight as measured in kilograms (kg).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6 month follow-up visit.Hand grip strength as assessed by a dynamometer. Grip strength is recorded (in mmHg) three times for each hand. The average reading is reported for each hand.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6 month follow-up visit.Multi-dimensional Fatigue Inventory (MFI) Questionnaire contains 20 questions with a 5-point scale. The MFI has total score ranging from 20-100 with the higher score indicating less fatigue.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6 month follow-up visit.Investigating Choice Experiences for the Preferences of Older People (ICEpop) Capability measure for Older people (ICECAP) questionnaire has total score ranging from 5-20 with the higher score indicating greater quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6 month follow-up visit.Short Form (SF)-36 Questionnaire has consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. Lower scores indicate the more disability, and higher scores indicate less disability.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6 month follow-up visit.EuroQoL (EQ)- 5 Dimension (5D)- 3 levels (3L) Questionnaire has total score ranging from 0-10 for the 5 dimensions. Higher scores indicate better Quality of Life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6 month follow-up visit.EuroQoL - 5 Dimension - 3 levels (EQ-5D-3L) Overall health status question has a range of 0-100. Higher scores indicate better Quality of Life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6 month follow-up visit.University of Pennsylvania Smell Identification Test (UPSIT) smell test booklet has a total score ranging from 0-40 with higher scores indicating better olfaction.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 months.Any reported death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6 month follow-up visit.Change in dobutamine stress echocardiogram induced ejection fraction
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6 month follow-up visit.Change in inflammatory markers including C-Reactive Protein (CRP) and Fibrinogen serum samples as measured in mg/L.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6 month follow-up visit.Change in inflammatory markers including Interleukin (IL)-6 and Tumor Necrosis Factor (TNF) Alpha from serum samples as measured in pg/mL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6 month follow-up visit.Change in inflammatory marker D-Dimer from serum samples as measured in mg/dL.
Outcome measures
Outcome data not reported
Adverse Events
Pilot Phase - Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pilot Phase - Group 2
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Pilot Phase - Group 3
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Randomized Phase - Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Randomized Phase - Group B
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Randomized Phase - Group C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Addendum B - Antibiotic Free Cell Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Pilot Phase - Group 1
n=5 participants at risk
Group 1 participants will receive Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 20 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Pilot Phase - Group 2
n=5 participants at risk
Group 2 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Pilot Phase - Group 3
n=5 participants at risk
Group 3 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Randomized Phase - Group A
n=10 participants at risk
Group A - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Randomized Phase - Group B
n=10 participants at risk
Group B - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
|
Randomized Phase - Group C
n=10 participants at risk
Group C - Placebo delivered via peripheral intravenous infusion. Participants in this group have the option to receive one additional infusion of 100million allo-hMSCs/kg with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
Placebo: Placebo administered by peripheral intravenous infusion.
|
Addendum B - Antibiotic Free Cell Group
n=20 participants at risk
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million penicillin/streptomycin-free allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Vascular disorders
Stroke
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/10 • Up to 6 years
|
0.00%
0/10 • Up to 6 years
|
0.00%
0/10 • Up to 6 years
|
5.0%
1/20 • Number of events 1 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/5 • Up to 6 years
|
20.0%
1/5 • Number of events 1 • Up to 6 years
|
0.00%
0/10 • Up to 6 years
|
0.00%
0/10 • Up to 6 years
|
0.00%
0/10 • Up to 6 years
|
0.00%
0/20 • Up to 6 years
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/10 • Up to 6 years
|
10.0%
1/10 • Number of events 1 • Up to 6 years
|
0.00%
0/10 • Up to 6 years
|
0.00%
0/20 • Up to 6 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/10 • Up to 6 years
|
10.0%
1/10 • Number of events 1 • Up to 6 years
|
0.00%
0/10 • Up to 6 years
|
0.00%
0/20 • Up to 6 years
|
|
Renal and urinary disorders
Microscopic Hematuria
|
0.00%
0/5 • Up to 6 years
|
20.0%
1/5 • Number of events 1 • Up to 6 years
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/10 • Up to 6 years
|
0.00%
0/10 • Up to 6 years
|
0.00%
0/10 • Up to 6 years
|
0.00%
0/20 • Up to 6 years
|
Other adverse events
Adverse event data not reported
Additional Information
Joshua M Hare, MD
University of Miami, Miller School of Medicine - Interdisciplinary Stem Cell Institute (ISCI)
Phone: 305-243-5579
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place