Trial Outcomes & Findings for Stem Cell Injection in Cancer Survivors (NCT NCT02509156)
NCT ID: NCT02509156
Last Updated: 2020-11-05
Results Overview
Proportion of adjudicated events including death, hospitalization for worsening heart failure, and/or other exacerbation of heart failure (non-hospitalization).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
Baseline to 12 months
Results posted on
2020-11-05
Participant Flow
Enrollment took place at seven CCTRN centers between September 2016 and October 2018. The main centers are located in Texas, Florida (2 locations), Minnesota, Kentucky, Indiana, and California. Recruitment methods included www.clinicaltrials.gov, cancer survivorship organization websites, and local cancer center physician outreach.
46 subjects consented to participate; 37 completed baseline testing and met eligibility criteria. This includes 6 (open label) and 31 (randomized) subjects. Reasons for failed eligibility (n=9) include elevated LVEF, failure to complete baseline testing, MRI contraindications, and investigator discretion.
Participant milestones
| Measure |
Allo-MSCs
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Open-Label Lead-In Phase
STARTED
|
6
|
0
|
|
Open-Label Lead-In Phase
COMPLETED
|
6
|
0
|
|
Open-Label Lead-In Phase
NOT COMPLETED
|
0
|
0
|
|
Randomized Phase
STARTED
|
14
|
17
|
|
Randomized Phase
COMPLETED
|
12
|
16
|
|
Randomized Phase
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Allo-MSCs
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Randomized Phase
Death
|
1
|
0
|
|
Randomized Phase
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Limited information due to treatment record availability (\>15yrs). Dosing information (mg/m\^2) not always available. Data represents a subset of the cohort.
Baseline characteristics by cohort
| Measure |
Allo-MSCs
n=14 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=17 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 12.8 • n=14 Participants
|
58.2 years
STANDARD_DEVIATION 11.2 • n=17 Participants
|
56.6 years
STANDARD_DEVIATION 11.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=14 Participants
|
13 Participants
n=17 Participants
|
21 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=14 Participants
|
4 Participants
n=17 Participants
|
10 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=14 Participants
|
3 Participants
n=17 Participants
|
4 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=14 Participants
|
13 Participants
n=17 Participants
|
25 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=14 Participants
|
3 Participants
n=17 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=14 Participants
|
13 Participants
n=17 Participants
|
21 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=14 Participants
|
1 Participants
n=17 Participants
|
3 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
17 participants
n=17 Participants
|
31 participants
n=31 Participants
|
|
Body Mass Index
|
30.2 kg/m^2
STANDARD_DEVIATION 9 • n=14 Participants
|
30.4 kg/m^2
STANDARD_DEVIATION 6.5 • n=17 Participants
|
30.3 kg/m^2
STANDARD_DEVIATION 7.6 • n=31 Participants
|
|
Heart rate
|
74.4 beats per minute
STANDARD_DEVIATION 9 • n=14 Participants
|
76.1 beats per minute
STANDARD_DEVIATION 11.2 • n=17 Participants
|
75.4 beats per minute
STANDARD_DEVIATION 10.1 • n=31 Participants
|
|
Systolic blood pressure
|
118.6 mmHg
STANDARD_DEVIATION 21.6 • n=14 Participants
|
115.4 mmHg
STANDARD_DEVIATION 11.0 • n=17 Participants
|
116.8 mmHg
STANDARD_DEVIATION 16.4 • n=31 Participants
|
|
Diastolic blood pressure
|
68.9 mmHg
STANDARD_DEVIATION 18.6 • n=14 Participants
|
67.1 mmHg
STANDARD_DEVIATION 11.2 • n=17 Participants
|
67.9 mmHg
STANDARD_DEVIATION 14.7 • n=31 Participants
|
|
Diabetes
|
3 Participants
n=14 Participants
|
5 Participants
n=17 Participants
|
8 Participants
n=31 Participants
|
|
Hypertension
|
6 Participants
n=14 Participants
|
10 Participants
n=17 Participants
|
16 Participants
n=31 Participants
|
|
Smoking (lifetime)
|
5 Participants
n=14 Participants
|
3 Participants
n=17 Participants
|
8 Participants
n=31 Participants
|
|
Left ventricular ejection fraction
|
33.7 percentage of blood ejected
STANDARD_DEVIATION 3.4 • n=14 Participants
|
32.5 percentage of blood ejected
STANDARD_DEVIATION 6.5 • n=17 Participants
|
33.0 percentage of blood ejected
STANDARD_DEVIATION 5.3 • n=31 Participants
|
|
Previous hospitalization for heart failure
|
7 Participants
n=14 Participants
|
8 Participants
n=17 Participants
|
15 Participants
n=31 Participants
|
|
Previous emergency department visit for heart failure
|
4 Participants
n=14 Participants
|
3 Participants
n=17 Participants
|
7 Participants
n=31 Participants
|
|
Time since AIC diagnosis
|
6.1 years
STANDARD_DEVIATION 5.9 • n=14 Participants
|
8.7 years
STANDARD_DEVIATION 5.0 • n=17 Participants
|
7.5 years
STANDARD_DEVIATION 5.5 • n=31 Participants
|
|
New York Heart Association class II
|
13 Participants
n=14 Participants
|
13 Participants
n=17 Participants
|
26 Participants
n=31 Participants
|
|
New York Heart Association class III
|
1 Participants
n=14 Participants
|
4 Participants
n=17 Participants
|
5 Participants
n=31 Participants
|
|
Presence of a cardiac device
|
6 Participants
n=14 Participants
|
12 Participants
n=17 Participants
|
18 Participants
n=31 Participants
|
|
Angina
|
3 Participants
n=14 Participants
|
5 Participants
n=17 Participants
|
8 Participants
n=31 Participants
|
|
Sustained ventricular arrhythmia
|
5 Participants
n=14 Participants
|
7 Participants
n=17 Participants
|
12 Participants
n=31 Participants
|
|
Leukemia
|
3 Participants
n=14 Participants
|
0 Participants
n=17 Participants
|
3 Participants
n=31 Participants
|
|
Breast cancer
|
6 Participants
n=14 Participants
|
9 Participants
n=17 Participants
|
15 Participants
n=31 Participants
|
|
Hodgkin's disease
|
0 Participants
n=14 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=31 Participants
|
|
Non-Hodgkin's lymphoma
|
1 Participants
n=14 Participants
|
5 Participants
n=17 Participants
|
6 Participants
n=31 Participants
|
|
Sarcomas
|
1 Participants
n=14 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=31 Participants
|
|
Multiple cancers
|
3 Participants
n=14 Participants
|
2 Participants
n=17 Participants
|
5 Participants
n=31 Participants
|
|
Doxorubicin
|
11 Participants
n=14 Participants
|
17 Participants
n=17 Participants
|
28 Participants
n=31 Participants
|
|
Epirubicin
|
1 Participants
n=14 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=31 Participants
|
|
Daunorubicin
|
2 Participants
n=14 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=31 Participants
|
|
AIC exposure
|
353.0 mg/m^2
STANDARD_DEVIATION 351.3 • n=10 Participants • Limited information due to treatment record availability (\>15yrs). Dosing information (mg/m\^2) not always available. Data represents a subset of the cohort.
|
339.5 mg/m^2
STANDARD_DEVIATION 113.6 • n=10 Participants • Limited information due to treatment record availability (\>15yrs). Dosing information (mg/m\^2) not always available. Data represents a subset of the cohort.
|
346.2 mg/m^2
STANDARD_DEVIATION 254.2 • n=20 Participants • Limited information due to treatment record availability (\>15yrs). Dosing information (mg/m\^2) not always available. Data represents a subset of the cohort.
|
|
Time from Cancer Diagnosis
|
16.4 years
STANDARD_DEVIATION 9.5 • n=14 Participants
|
18.8 years
STANDARD_DEVIATION 8.5 • n=17 Participants
|
17.7 years
STANDARD_DEVIATION 8.9 • n=31 Participants
|
|
Time from last anthracycline treatment
|
13.3 years
STANDARD_DEVIATION 9.3 • n=14 Participants
|
16.8 years
STANDARD_DEVIATION 7.6 • n=17 Participants
|
15.2 years
STANDARD_DEVIATION 8.4 • n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: Population for safety and feasibility measures include open label lead-in participants (n=6) as well as randomized subjects (n=31).
Proportion of adjudicated events including death, hospitalization for worsening heart failure, and/or other exacerbation of heart failure (non-hospitalization).
Outcome measures
| Measure |
Allo-MSCs
n=20 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=17 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Proportion of Major Adverse Cardiac Events (MACE)
|
3 events
|
6 events
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: Population for safety and feasibility measures include open label lead-in participants (n=6) as well as randomized subjects (n=31).
Proportion of other significant adjudicated clinical events including: non-fatal stroke, non-fatal MI, coronary artery revascularization, ventricular tachycardia/fibrillation, pericardial tamponade, infectious myocarditis, hypersensitivity reaction, neoplasm, and/or other potential deleterious late effects.
Outcome measures
| Measure |
Allo-MSCs
n=20 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=17 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Proportion of Other Significant Clinical Events
|
0 events
|
1 events
|
PRIMARY outcome
Timeframe: Randomization to SPIPopulation: Population for safety and feasibility measures include open label lead-in participants (n=6) as well as randomized subjects (n=31).
Number and percent of subjects with events between randomization and study product injection (SPI) that preclude the subject from receiving product.
Outcome measures
| Measure |
Allo-MSCs
n=20 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=17 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Subjects With Events Precluding Their Receipt of Product
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: During SPI procedurePopulation: Population for safety and feasibility measures include open label lead-in participants (n=6) as well as randomized subjects who were participating at the time of study product injection (n=30). Note: one placebo patient withdrew after randomization but prior to injection visit.
Number and percent of subjects who receive less than 20 injections during SPI
Outcome measures
| Measure |
Allo-MSCs
n=20 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=16 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Subjects Who Receive Less Than 20 Injections During SPI
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During SPI procedurePopulation: Population for safety and feasibility measures include open label lead-in participants (n=6) as well as randomized subjects who were participating at the time of study product injection (n=30). Note: one placebo patient withdrew after randomization but prior to injection visit.
Number and percent of subjects who did not receive the study product (either 100 million cells or placebo)
Outcome measures
| Measure |
Allo-MSCs
n=20 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=16 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Subjects Who Did Not Receive the Study Product (Either 100 Million Cells or Placebo)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: Population for safety and feasibility measures include open label lead-in participants (n=6) as well as randomized subjects (n=31). Analysis population includes only participants who completed an MRI at 12 months (n=32).
Number and percent of subjects who have at least one cardiac MRI endpoint measure that is uninterpretable due to issues related to the device, including, but not limited to, inability to undergo the procedure.
Outcome measures
| Measure |
Allo-MSCs
n=18 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=14 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Subjects Who Have at Least One Cardiac MRI Endpoint Measure That is Uninterpretable
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: Population for safety and feasibility analysis include open label lead-in participants (n=6)
Number and percent of subjects who fail to complete follow up
Outcome measures
| Measure |
Allo-MSCs
n=20 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=17 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Subjects Who Fail to Complete Follow-up
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants who had available analyzable LVEF at baseline and 12 month.
Change in left ventricular ejection fraction as assessed via cardiac MRI.
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=13 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
|
3.47 percentage of end diastolic volume
Standard Deviation 6.00
|
2.68 percentage of end diastolic volume
Standard Deviation 6.85
|
SECONDARY outcome
Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)Population: Participants who had available analyzable LVEF at baseline, 6 month, and 12 month.
The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=13 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Left Ventricular Ejection Fraction (LVEF)-Trajectory
|
1.81 percentage of end diastolic volume
Standard Error 0.86
|
1.33 percentage of end diastolic volume
Standard Error 0.95
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants with available analyzable global circumferential strain at baseline and 12 months
Change in global circumferential strain as assessed via cardiac MRI
Outcome measures
| Measure |
Allo-MSCs
n=11 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=13 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Global Strain (HARP MRI)
|
-0.83 percent
Standard Deviation 1.70
|
-0.12 percent
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)Population: Participants who had available analyzable global strain at baseline, 6 month, and 12 month.
The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.
Outcome measures
| Measure |
Allo-MSCs
n=11 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=13 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Global Strain (HARP MRI)-Trajectory
|
-0.49 percent
Standard Error 0.24
|
-0.04 percent
Standard Error 0.36
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants with available analyzable regional longitudinal strain at baseline and 12 months
Change in regional longitudinal strain as assessed via cardiac MRI
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=13 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Regional Strain (HARP MRI)
|
-1.20 percent
Standard Deviation 3.34
|
0.38 percent
Standard Deviation 3.73
|
SECONDARY outcome
Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)Population: Participants who had available analyzable regional strain at baseline, 6 month, and 12 month.
The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=13 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Regional Strain (HARP MRI)-Trajectory
|
-0.58 percent
Standard Error 0.42
|
0.21 percent
Standard Error 0.52
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants with available analyzable LVEDVI at baseline and 12 months
Change in left ventricular end diastolic volume index as measured via cardiac MRI
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=13 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI)
|
-2.30 ratio- unitless
Standard Deviation 16.97
|
-3.36 ratio- unitless
Standard Deviation 15.18
|
SECONDARY outcome
Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)Population: Participants who had available analyzable LVEDVI at baseline, 6 month, and 12 month.
The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=13 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI)-Trajectory
|
-0.94 ratio-unitless
Standard Error 2.38
|
-1.98 ratio-unitless
Standard Error 1.95
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants with available analyzable LVESVI at baseline and 12 months
Change in left ventricular end systolic volume index as assessed via cardiac MRI
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=13 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI)
|
-3.62 ratio- unitless
Standard Deviation 15.66
|
-4.28 ratio- unitless
Standard Deviation 14.18
|
SECONDARY outcome
Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)Population: Participants who had available analyzable LVESVI at baseline, 6 month, and 12 month.
The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=13 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI)-Trajectory
|
-2.05 ratio- unitless
Standard Error 2.14
|
-2.34 ratio- unitless
Standard Error 1.81
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants who had available analyzable LV sphericity index at baseline and 12 month LV.
Change in Left Ventricular Sphericity Index as assessed by cardiac MRI. Sphericity index is the ratio of the long and short axis measurements of the left ventricle.
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=13 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Left Ventricular Sphericity Index
|
0.01 ratio- unitless
Standard Deviation 0.08
|
-0.07 ratio- unitless
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)Population: Participants who had available analyzable sphericity index at baseline, 6 month, and 12 month.
The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model. Sphericity index is the ratio of the long and short axis measurements of the left ventricle.
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=13 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Left Ventricular Sphericity Index-Trajectory
|
0.005 ratio-unitless
Standard Error 0.013
|
-0.037 ratio-unitless
Standard Error 0.012
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants who had available analyzable scar percent at baseline and 12 month.
Change in the scar percent (scar mass normalized to left ventricular mass) as assessed via cardiac MRI.
Outcome measures
| Measure |
Allo-MSCs
n=11 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=10 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Area of Injury
|
-1.06 percentage of mass
Standard Deviation 2.44
|
-0.41 percentage of mass
Standard Deviation 2.76
|
SECONDARY outcome
Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)Population: Participants who had available analyzable scar percent at baseline, 6 month, and 12 month.
The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.
Outcome measures
| Measure |
Allo-MSCs
n=11 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=10 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Area of Injury-Trajectory
|
-0.56 percentage of mass
Standard Error 0.41
|
-0.27 percentage of mass
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants who had available analyzable walk tests at baseline and 12 month.
Change in the distance walked (in meters) as measured by the six minute walk test. Two walk tests were completed at each endpoint visit (separated by 30 min). The average distance of the two walk tests will be used for analysis.
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=15 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Exercise Tolerance (Six Minute Walk Test)
|
34.96 meters
Standard Deviation 61.62
|
-3.07 meters
Standard Deviation 42.90
|
SECONDARY outcome
Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)Population: Participants who had available analyzable six minute walk test data at baseline, 6 month, and 12 month.
Change in the distance walked (in feet) as measured by the six minute walk test. Two walk tests were completed at each endpoint visit (separated by 30 min). The average distance of the two walk tests will be used for analysis. The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=15 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Exercise Tolerance (Six Minute Walk Test)-Trajectory
|
9.81 meters
Standard Error 7.53
|
-3.43 meters
Standard Error 5.72
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants who had available analyzable MLHFQ summary score at baseline and 12 month.
Change in the quality of life summary score as measured by the Minnesota Living with Heart Failure Questionnaire. Minimum and maximum scores for scale are 0 and 105 respectively. Lower scores indicative of better outcome.
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=14 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score
|
-25.45 score on a scale
Standard Deviation 25.65
|
-12.63 score on a scale
Standard Deviation 14.59
|
SECONDARY outcome
Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)Population: Participants who had available analyzable MLHFQ data at baseline, 6 month, and 12 month.
The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model. Minimum and maximum scores for scale are 0 and 105 respectively. Lower scores indicative of better outcome.
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=14 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score-Trajectory
|
-10.15 score on a scale
Standard Error 2.94
|
-6.05 score on a scale
Standard Error 1.92
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants who had available analyzable NT-proBNP results at baseline and 12 month. Log transformation used. p-values were obtained from transformed data.
Change in N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) as measured via laboratory blood draw
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=15 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
|
-392.58 pg/ml
Standard Deviation 953.71
|
-76.76 pg/ml
Standard Deviation 410.48
|
SECONDARY outcome
Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)Population: Participants who had available analyzable NT-proBNP results at baseline, 6 month, and 12 month. Log transformation used for the regression. p-values were obtained from transformed data.
The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.
Outcome measures
| Measure |
Allo-MSCs
n=12 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=15 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)-Trajectory
|
-184.18 pg/ml
Standard Error 113.16
|
-58.58 pg/ml
Standard Error 49.41
|
SECONDARY outcome
Timeframe: Baseline to End of 12 Month Visit Window (i.e. 395 days after intervention)Population: Comparison of the two groups on days alive and out of the hospital for heart failure during the 12 month study evaluation period. Analysis includes all study subjects (including the 6 open label patients).
Days alive and out of hospital for heart failure during the study evaluation period. Subjects were allotted a visit window extending 30 days past their anticipated 12-month visit (i.e., 395 days).
Outcome measures
| Measure |
Allo-MSCs
n=20 Participants
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=16 Participants
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Cumulative Days Alive and Out of Hospital for Heart Failure
|
368 days
Standard Deviation 25.8
|
363 days
Standard Deviation 31.9
|
Adverse Events
Allo-MSCs
Serious events: 5 serious events
Other events: 4 other events
Deaths: 1 deaths
Placebo
Serious events: 11 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Allo-MSCs
n=20 participants at risk
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=17 participants at risk
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Cardiac disorders
Cardiac failure acute
|
10.0%
2/20 • Number of events 2 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
11.8%
2/17 • Number of events 3 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Cardiac disorders
Cardiac failure
|
5.0%
1/20 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
11.8%
2/17 • Number of events 3 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Cardiac disorders
Ventricular tachycardia
|
5.0%
1/20 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Cardiac disorders
Cardiovascular deconditioning
|
5.0%
1/20 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
0.00%
0/17 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Gastrointestinal disorders
Chrohn's disease
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
General disorders
Sudden cardiac death
|
5.0%
1/20 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
0.00%
0/17 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Hepatobiliary disorders
Drug induced liver injury
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Infections and infestations
Post operative wound infection
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
5.0%
1/20 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
0.00%
0/17 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.0%
1/20 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
0.00%
0/17 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.0%
1/20 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
0.00%
0/17 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Nervous system disorders
Transient ischaemic attack
|
5.0%
1/20 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
0.00%
0/17 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Product Issues
Lead dislodgement
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Product Issues
Device lead damage
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
5.9%
1/17 • Number of events 1 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
Other adverse events
| Measure |
Allo-MSCs
n=20 participants at risk
Target dose of 100 million allo-MSCs
Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
Placebo
n=17 participants at risk
Buminate solution
Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
|
|---|---|---|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/20 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
23.5%
4/17 • Number of events 4 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Cardiac disorders
Pericardial effusion
|
10.0%
2/20 • Number of events 2 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
0.00%
0/17 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
|
Investigations
Glomerular filtration rate decreased
|
10.0%
2/20 • Number of events 2 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
0.00%
0/17 • Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
|
Additional Information
Shelly Sayre, M.P.H. Project Manager
University of Texas-Houston School of Public Health
Phone: 713-500-9529
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place