Trial Outcomes & Findings for Serial Infusions of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients With Left Ventricular Assist Device (NCT NCT03925324)
NCT ID: NCT03925324
Last Updated: 2022-02-02
Results Overview
Temperature
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
up to 12 months post enrollment
Results posted on
2022-02-02
Participant Flow
Participant milestones
| Measure |
Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
Three intravenous infusions of 1.5 million (aMBMC) per kg administered at approximately 2mL/min. Maximum dose as for 100kg subject or 150 million cells for any subject 100kg or more with each infusion 1 month apart.
Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC): Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg
|
Placebo
Three intravenous infusions of 1.5 mL/kg Lactated Ringer's Solution with each infusion 1 month apart.
Placebo: 1.5 mL/kg Lactated Ringer's Solution
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
Three intravenous infusions of 1.5 million (aMBMC) per kg administered at approximately 2mL/min. Maximum dose as for 100kg subject or 150 million cells for any subject 100kg or more with each infusion 1 month apart.
Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC): Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg
|
Placebo
Three intravenous infusions of 1.5 mL/kg Lactated Ringer's Solution with each infusion 1 month apart.
Placebo: 1.5 mL/kg Lactated Ringer's Solution
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
Baseline Characteristics
Serial Infusions of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients With Left Ventricular Assist Device
Baseline characteristics by cohort
| Measure |
Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
n=2 Participants
Three intravenous infusions of 1.5 million (aMBMC) per kg administered at approximately 2mL/min. Maximum dose as for 100kg subject or 150 million cells for any subject 100kg or more with each infusion 1 month apart.
Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC): Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg
|
Placebo
n=2 Participants
Three intravenous infusions of 1.5 mL/kg Lactated Ringer's Solution with each infusion 1 month apart.
Placebo: 1.5 mL/kg Lactated Ringer's Solution
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 12 months post enrollmentPopulation: Due to study termination and small sample size, no analysis was performed
Temperature
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: up to 12 months post enrollmentPopulation: Due to study termination and small sample size, no analysis was performed
Number of admission for uncontrolled systemic infection
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: up to 12 months post enrollmentRate of Death
Outcome measures
| Measure |
Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
n=2 Participants
Three intravenous infusions of 1.5 million (aMBMC) per kg administered at approximately 2mL/min. Maximum dose as for 100kg subject or 150 million cells for any subject 100kg or more with each infusion 1 month apart.
Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC): Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg
|
Placebo
n=2 Participants
Three intravenous infusions of 1.5 mL/kg Lactated Ringer's Solution with each infusion 1 month apart.
Placebo: 1.5 mL/kg Lactated Ringer's Solution
|
|---|---|---|
|
All-cause Mortality
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to day 90Population: Due to study termination and small sample size, no analysis was performed
percent reduction in NK cells
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and day 90 post initial infusionPopulation: Due to study termination and small sample size, no analysis was performed
The change in the lab values N-Terminal Prohormone of Brain Natriuretic Peptide (NT-ProBNP)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and day 90 post initial infusionPopulation: Due to study termination and small sample size, no analysis was performed
Change in RV systolic function
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: day 90Population: Due to study termination and small sample size, no analysis was performed
Number of hospitalizations for to right heart failure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and day 90 post initial infusionPopulation: Test was not performed for any subjects at 90 days, therefore no changes could be analyzed
6 minute walk distance changes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 90Population: Due to study termination and small sample size, no analysis was performed
Count of gout flares
Outcome measures
Outcome data not reported
Adverse Events
Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Placebo
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
n=2 participants at risk
Three intravenous infusions of 1.5 million (aMBMC) per kg administered at approximately 2mL/min. Maximum dose as for 100kg subject or 150 million cells for any subject 100kg or more with each infusion 1 month apart.
Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC): Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg
|
Placebo
n=2 participants at risk
Three intravenous infusions of 1.5 mL/kg Lactated Ringer's Solution with each infusion 1 month apart.
Placebo: 1.5 mL/kg Lactated Ringer's Solution
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Esophageal Obstruction/Cancer
|
0.00%
0/2 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
50.0%
1/2 • Number of events 1 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PEG Placement
|
0.00%
0/2 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
50.0%
1/2 • Number of events 1 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
|
Gastrointestinal disorders
Abdominal Pain/Hematemesis
|
0.00%
0/2 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
50.0%
1/2 • Number of events 1 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
|
Cardiac disorders
Acute Chronic Heart Failure
|
50.0%
1/2 • Number of events 1 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
0.00%
0/2 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
|
Cardiac disorders
Sub Therapeutic INR
|
50.0%
1/2 • Number of events 1 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
0.00%
0/2 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
|
Renal and urinary disorders
Acute on Chronic Renal Failure
|
50.0%
1/2 • Number of events 1 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
0.00%
0/2 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/2 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
50.0%
1/2 • Number of events 1 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
|
Infections and infestations
MRSA Bacteremia
|
0.00%
0/2 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
50.0%
1/2 • Number of events 1 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
Other adverse events
| Measure |
Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
n=2 participants at risk
Three intravenous infusions of 1.5 million (aMBMC) per kg administered at approximately 2mL/min. Maximum dose as for 100kg subject or 150 million cells for any subject 100kg or more with each infusion 1 month apart.
Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC): Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg
|
Placebo
n=2 participants at risk
Three intravenous infusions of 1.5 mL/kg Lactated Ringer's Solution with each infusion 1 month apart.
Placebo: 1.5 mL/kg Lactated Ringer's Solution
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Non-Productive Cough
|
50.0%
1/2 • Number of events 1 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
0.00%
0/2 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
|
Cardiac disorders
Sub-Therapeutic INR
|
100.0%
2/2 • Number of events 2 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
50.0%
1/2 • Number of events 1 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
|
Musculoskeletal and connective tissue disorders
Lower Back Pain
|
50.0%
1/2 • Number of events 1 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
0.00%
0/2 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
|
Cardiac disorders
LAVD Alarm Issue
|
0.00%
0/2 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
50.0%
1/2 • Number of events 2 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
|
Infections and infestations
PICC Line Replacement
|
0.00%
0/2 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
50.0%
1/2 • Number of events 1 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
|
Musculoskeletal and connective tissue disorders
Back/Shoulder/Neck Pain
|
0.00%
0/2 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
50.0%
1/2 • Number of events 1 • 1 year post randomization
Clinicaltrials.gov definitions used.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place