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Stem Cell Injection in Cancer Survivors (SENECA)

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ClinicalTrials.gov Identifier: NCT02509156
Recruitment Status : Completed
First Posted : July 27, 2015
Results First Posted : November 5, 2020
Last Update Posted : November 5, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Barry R Davis, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cardiomyopathy Due to Anthracyclines
Interventions Biological: Allo-MSCs
Biological: Placebo
Enrollment 46
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Period Title: Open-Label Lead-In Phase
Started 6 0
Completed 6 0
Not Completed 0 0
Period Title: Randomized Phase
Started 14 [1] 17
Completed 12 16
Not Completed 2 1
Reason Not Completed
Death             1             0
Withdrawal by Subject             1             1
[1]
Includes randomized participants only
Arm/Group Title Allo-MSCs Placebo Total
Hide Arm/Group Description

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Total of all reporting groups
Overall Number of Baseline Participants 14 17 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 17 participants 31 participants
54.7  (12.8) 58.2  (11.2) 56.6  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
Female
8
  57.1%
13
  76.5%
21
  67.7%
Male
6
  42.9%
4
  23.5%
10
  32.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
Hispanic or Latino
1
   7.1%
3
  17.6%
4
  12.9%
Not Hispanic or Latino
12
  85.7%
13
  76.5%
25
  80.6%
Unknown or Not Reported
1
   7.1%
1
   5.9%
2
   6.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  28.6%
3
  17.6%
7
  22.6%
White
8
  57.1%
13
  76.5%
21
  67.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
  14.3%
1
   5.9%
3
   9.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 17 participants 31 participants
14 17 31
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 14 participants 17 participants 31 participants
30.2  (9) 30.4  (6.5) 30.3  (7.6)
Heart rate  
Mean (Standard Deviation)
Unit of measure:  Beats per minute
Number Analyzed 14 participants 17 participants 31 participants
74.4  (9) 76.1  (11.2) 75.4  (10.1)
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 14 participants 17 participants 31 participants
118.6  (21.6) 115.4  (11.0) 116.8  (16.4)
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 14 participants 17 participants 31 participants
68.9  (18.6) 67.1  (11.2) 67.9  (14.7)
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
3
  21.4%
5
  29.4%
8
  25.8%
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
6
  42.9%
10
  58.8%
16
  51.6%
Smoking (lifetime)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
5
  35.7%
3
  17.6%
8
  25.8%
Left ventricular ejection fraction  
Mean (Standard Deviation)
Unit of measure:  Percentage of blood ejected
Number Analyzed 14 participants 17 participants 31 participants
33.7  (3.4) 32.5  (6.5) 33.0  (5.3)
Previous hospitalization for heart failure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
7
  50.0%
8
  47.1%
15
  48.4%
Previous emergency department visit for heart failure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
4
  28.6%
3
  17.6%
7
  22.6%
Time since AIC diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 17 participants 31 participants
6.1  (5.9) 8.7  (5.0) 7.5  (5.5)
[1]
Measure Description: Time since anthracycline induced cardiomyopathy diagnosis (years)
New York Heart Association class II   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
13
  92.9%
13
  76.5%
26
  83.9%
[1]
Measure Description: Physicians use the NYHA classification system to place patients in one of four categories based on how much they are limited during physical activity. Class II is characterized by slight limitation of physical activity. The patient is comfortable at rest, however ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
New York Heart Association class III   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
1
   7.1%
4
  23.5%
5
  16.1%
[1]
Measure Description: Physicians use the NYHA classification system to place patients in one of four categories based on how much they are limited during physical activity. Class III is characterized by marked limitation of physical activity. The patient is comfortable at rest. Less than ordinary activity however, causes fatigue, palpitation, or dyspnea.
Presence of a cardiac device   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
6
  42.9%
12
  70.6%
18
  58.1%
[1]
Measure Description: Presence of a cardiac device (implantable cardioverter defibrillator or pacemaker)
Angina  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
3
  21.4%
5
  29.4%
8
  25.8%
Sustained ventricular arrhythmia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
5
  35.7%
7
  41.2%
12
  38.7%
Leukemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
3
  21.4%
0
   0.0%
3
   9.7%
Breast cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
6
  42.9%
9
  52.9%
15
  48.4%
Hodgkin's disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
0
   0.0%
1
   5.9%
1
   3.2%
Non-Hodgkin's lymphoma  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
1
   7.1%
5
  29.4%
6
  19.4%
Sarcomas  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
1
   7.1%
0
   0.0%
1
   3.2%
Multiple cancers  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
3
  21.4%
2
  11.8%
5
  16.1%
Doxorubicin  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
11
  78.6%
17
 100.0%
28
  90.3%
Epirubicin  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
1
   7.1%
0
   0.0%
1
   3.2%
Daunorubicin  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
2
  14.3%
0
   0.0%
2
   6.5%
AIC exposure   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg/m^2
Number Analyzed 10 participants 10 participants 20 participants
353.0  (351.3) 339.5  (113.6) 346.2  (254.2)
[1]
Measure Analysis Population Description: 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   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 17 participants 31 participants
16.4  (9.5) 18.8  (8.5) 17.7  (8.9)
[1]
Measure Description: Time from earliest diagnosis requiring anthracycline treatment
Time from last anthracycline treatment  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 17 participants 31 participants
13.3  (9.3) 16.8  (7.6) 15.2  (8.4)
1.Primary Outcome
Title Proportion of Major Adverse Cardiac Events (MACE)
Hide Description Proportion of adjudicated events including death, hospitalization for worsening heart failure, and/or other exacerbation of heart failure (non-hospitalization).
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population for safety and feasibility measures include open label lead-in participants (n=6) as well as randomized subjects (n=31).
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 20 17
Measure Type: Number
Unit of Measure: events
3 6
2.Primary Outcome
Title Proportion of Other Significant Clinical Events
Hide Description 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.
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population for safety and feasibility measures include open label lead-in participants (n=6) as well as randomized subjects (n=31).
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 20 17
Measure Type: Number
Unit of Measure: events
0 1
3.Primary Outcome
Title Subjects With Events Precluding Their Receipt of Product
Hide Description Number and percent of subjects with events between randomization and study product injection (SPI) that preclude the subject from receiving product.
Time Frame Randomization to SPI
Hide Outcome Measure Data
Hide Analysis Population Description
Population for safety and feasibility measures include open label lead-in participants (n=6) as well as randomized subjects (n=31).
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 20 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   5.9%
4.Primary Outcome
Title Subjects Who Receive Less Than 20 Injections During SPI
Hide Description Number and percent of subjects who receive less than 20 injections during SPI
Time Frame During SPI procedure
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 20 16
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
0
   0.0%
5.Primary Outcome
Title Subjects Who Did Not Receive the Study Product (Either 100 Million Cells or Placebo)
Hide Description Number and percent of subjects who did not receive the study product (either 100 million cells or placebo)
Time Frame During SPI procedure
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 20 16
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Subjects Who Have at Least One Cardiac MRI Endpoint Measure That is Uninterpretable
Hide Description 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.
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 18 14
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.6%
4
  28.6%
7.Primary Outcome
Title Subjects Who Fail to Complete Follow-up
Hide Description Number and percent of subjects who fail to complete follow up
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population for safety and feasibility analysis include open label lead-in participants (n=6)
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 20 17
Measure Type: Count of Participants
Unit of Measure: Participants
2
  10.0%
1
   5.9%
8.Secondary Outcome
Title Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Hide Description Change in left ventricular ejection fraction as assessed via cardiac MRI.
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable LVEF at baseline and 12 month.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: percentage of end diastolic volume
3.47  (6.00) 2.68  (6.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.746
Comments [Not Specified]
Method ANCOVA
Comments The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
-4.52 to 6.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.57
Estimation Comments Confidence intervals based on t-test
9.Secondary Outcome
Title Change From Baseline in Left Ventricular Ejection Fraction (LVEF)-Trajectory
Hide Description 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.
Time Frame Assessed as a trajectory (baseline, 6 months, and 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable LVEF at baseline, 6 month, and 12 month.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 13
Least Squares Mean (Standard Error)
Unit of Measure: percentage of end diastolic volume
1.81  (0.86) 1.33  (0.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments No adjustments for multiplicity were made in this Phase I trial
Method Repeated Measures Linear Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter slope of time
Estimated Value 1.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.63
Estimation Comments "Standard error of the mean" is the standard error of the estimate of the slope of time.
10.Secondary Outcome
Title Change From Baseline in Global Strain (HARP MRI)
Hide Description Change in global circumferential strain as assessed via cardiac MRI
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available analyzable global circumferential strain at baseline and 12 months
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 11 13
Mean (Standard Deviation)
Unit of Measure: percent
-0.83  (1.70) -0.12  (2.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments The change in global strain was compared using ANCOVA analyses adjusting for baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.328
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-2.68 to 1.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.94
Estimation Comments Confidence intervals based on t-test
11.Secondary Outcome
Title Change From Baseline in Global Strain (HARP MRI)-Trajectory
Hide Description 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.
Time Frame Assessed as a trajectory (baseline, 6 months, and 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable global strain at baseline, 6 month, and 12 month.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 11 13
Least Squares Mean (Standard Error)
Unit of Measure: percent
-0.49  (0.24) -0.04  (0.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.261
Comments No adjustments for multiplicity were made in this Phase I trial.
Method Repeated Measures Linear Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter slope of time
Estimated Value -0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments "Standard error of the mean" is the standard error of the estimate over time of the slope
12.Secondary Outcome
Title Change From Baseline in Regional Strain (HARP MRI)
Hide Description Change in regional longitudinal strain as assessed via cardiac MRI
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available analyzable regional longitudinal strain at baseline and 12 months
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: percent
-1.20  (3.34) 0.38  (3.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments The change in regional strain was compared using ANCOVA analyses adjusting for baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.58
Confidence Interval (2-Sided) 95%
-4.51 to 1.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.41
Estimation Comments Confidence intervals based on t-test
13.Secondary Outcome
Title Change From Baseline in Regional Strain (HARP MRI)-Trajectory
Hide Description 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.
Time Frame Assessed as a trajectory (baseline, 6 months, and 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable regional strain at baseline, 6 month, and 12 month.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 13
Least Squares Mean (Standard Error)
Unit of Measure: percent
-0.58  (0.42) 0.21  (0.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.689
Comments No adjustments for multiplicity were made in this Phase I trial.
Method Repeated Measures Linear Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter slope of time
Estimated Value -0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.35
Estimation Comments "Standard error of the mean" is the standard error of the estimate over time of the slope
14.Secondary Outcome
Title Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI)
Hide Description Change in left ventricular end diastolic volume index as measured via cardiac MRI
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available analyzable LVEDVI at baseline and 12 months
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: ratio- unitless
-2.30  (16.97) -3.36  (15.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.935
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
-12.33 to 14.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.46
Estimation Comments Confidence intervals based on t-test
15.Secondary Outcome
Title Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI)-Trajectory
Hide Description 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.
Time Frame Assessed as a trajectory (baseline, 6 months, and 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable LVEDVI at baseline, 6 month, and 12 month.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 13
Least Squares Mean (Standard Error)
Unit of Measure: ratio-unitless
-0.94  (2.38) -1.98  (1.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.325
Comments No adjustments for multiplicity were made in this Phase I trial.
Method Repeated Measures Linear Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter slope of time
Estimated Value -1.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.55
Estimation Comments "Standard error of the mean" is the standard error of the estimate over time of the slope
16.Secondary Outcome
Title Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI)
Hide Description Change in left ventricular end systolic volume index as assessed via cardiac MRI
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available analyzable LVESVI at baseline and 12 months
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: ratio- unitless
-3.62  (15.66) -4.28  (14.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.919
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
-11.75 to 13.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.99
Estimation Comments Confidence intervals based on t-test
17.Secondary Outcome
Title Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI)-Trajectory
Hide Description 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.
Time Frame Assessed as a trajectory (baseline, 6 months, and 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable LVESVI at baseline, 6 month, and 12 month.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 13
Least Squares Mean (Standard Error)
Unit of Measure: ratio- unitless
-2.05  (2.14) -2.34  (1.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.183
Comments No adjustments for multiplicity were made in this Phase I trial.
Method Repeated Measures Linear Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter slope of time
Estimated Value -1.99
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.45
Estimation Comments "Standard error of the mean" is the standard error of the estimate over time of the slope.
18.Secondary Outcome
Title Change From Baseline in Left Ventricular Sphericity Index
Hide Description 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.
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable LV sphericity index at baseline and 12 month LV.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: ratio- unitless
0.01  (0.08) -0.07  (0.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments The change in LV sphericity index was compared using ANCOVA analyses adjusting for baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.077
Confidence Interval (2-Sided) 95%
0.003 to 0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.035
Estimation Comments Confidence intervals based on t-test
19.Secondary Outcome
Title Change From Baseline in Left Ventricular Sphericity Index-Trajectory
Hide Description

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.

Time Frame Assessed as a trajectory (baseline, 6 months, and 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable sphericity index at baseline, 6 month, and 12 month.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 13
Least Squares Mean (Standard Error)
Unit of Measure: ratio-unitless
0.005  (0.013) -0.037  (0.012)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. A time by treatment interaction was assessed.
Type of Statistical Test Superiority
Comments [Not Specified]
Other Statistical Analysis There was a significant treatment and time interaction (p=0.024), so we report a slope for each treatment arm.
20.Secondary Outcome
Title Change From Baseline in Area of Injury
Hide Description Change in the scar percent (scar mass normalized to left ventricular mass) as assessed via cardiac MRI.
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable scar percent at baseline and 12 month.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 11 10
Mean (Standard Deviation)
Unit of Measure: percentage of mass
-1.06  (2.44) -0.41  (2.76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments The change in scar percent was compared using ANCOVA analyses adjusting for baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.993
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-3.05 to 1.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.14
Estimation Comments Confidence intervals based on t-test
21.Secondary Outcome
Title Change From Baseline in Area of Injury-Trajectory
Hide Description 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.
Time Frame Assessed as a trajectory (baseline, 6 months, and 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable scar percent at baseline, 6 month, and 12 month.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 11 10
Least Squares Mean (Standard Error)
Unit of Measure: percentage of mass
-0.56  (0.41) -0.27  (0.43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments No adjustments for multiplicity were made in this Phase I trial.
Method Repeated Measures Linear Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter slope of time
Estimated Value -0.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments "Standard error of the mean" is the standard error of the estimate over time of the slope
22.Secondary Outcome
Title Change From Baseline in Exercise Tolerance (Six Minute Walk Test)
Hide Description 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.
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable walk tests at baseline and 12 month.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 15
Mean (Standard Deviation)
Unit of Measure: meters
34.96  (61.62) -3.07  (42.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments The change in distance walked was compared using ANCOVA analyses adjusting for baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 38.03
Confidence Interval (2-Sided) 95%
-5.84 to 81.89
Parameter Dispersion
Type: Standard Error of the Mean
Value: 20.96
Estimation Comments Confidence intervals based on t-test
23.Secondary Outcome
Title Change From Baseline in Exercise Tolerance (Six Minute Walk Test)-Trajectory
Hide Description 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.
Time Frame Assessed as a trajectory (baseline, 6 months, and 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable six minute walk test data at baseline, 6 month, and 12 month.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 15
Least Squares Mean (Standard Error)
Unit of Measure: meters
9.81  (7.53) -3.43  (5.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.583
Comments No adjustments for multiplicity were made in this Phase I trial.
Method Repeated Measures Linear Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter slope of time
Estimated Value 2.82
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.06
Estimation Comments "Standard error of the mean" is the standard error of the estimate over time of the slope
24.Secondary Outcome
Title Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score
Hide Description 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.
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable MLHFQ summary score at baseline and 12 month.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
-25.45  (25.65) -12.63  (14.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.82
Confidence Interval (2-Sided) 95%
-30.49 to 4.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.37
Estimation Comments Confidence intervals based on t-test
25.Secondary Outcome
Title Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score-Trajectory
Hide Description

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.

Time Frame Assessed as a trajectory (baseline, 6 months, and 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable MLHFQ data at baseline, 6 month, and 12 month.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 14
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-10.15  (2.94) -6.05  (1.92)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments No adjustments for multiplicity were made in this Phase I trial.
Method Repeated Measures Linear Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter slope of time
Estimated Value -8.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.86
Estimation Comments "Standard error of the mean" is the standard error of the estimate over time of the slope.
26.Secondary Outcome
Title Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Hide Description Change in N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) as measured via laboratory blood draw
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable NT-proBNP results at baseline and 12 month. Log transformation used. p-values were obtained from transformed data.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 15
Mean (Standard Deviation)
Unit of Measure: pg/ml
-392.58  (953.71) -76.76  (410.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments The change in NT-proBNP was compared using ANCOVA analyses adjusting for baseline values. Data log transformed. p-values were obtained from transformed data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.199
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -315.80
Confidence Interval (2-Sided) 95%
-947.50 to 315.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 295
Estimation Comments Confidence intervals based on t-test
27.Secondary Outcome
Title Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)-Trajectory
Hide Description 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.
Time Frame Assessed as a trajectory (baseline, 6 months, and 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 12 15
Least Squares Mean (Standard Error)
Unit of Measure: pg/ml
-184.18  (113.16) -58.58  (49.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-MSCs, Placebo
Comments Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported. Log transformation used for the regression. p-values were obtained from transformed data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.229
Comments No adjustments for multiplicity were made in this Phase I trial.
Method Repeated Measures Linear Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter slope of time
Estimated Value -23.391
Parameter Dispersion
Type: Standard Error of the Mean
Value: 202.080
Estimation Comments "Standard error of the mean" is the standard error of the estimate over time of the slope
28.Secondary Outcome
Title Cumulative Days Alive and Out of Hospital for Heart Failure
Hide Description 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).
Time Frame Baseline to End of 12 Month Visit Window (i.e. 395 days after intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description:

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Overall Number of Participants Analyzed 20 16
Mean (Standard Deviation)
Unit of Measure: days
368  (25.8) 363  (31.9)
Time Frame Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Adverse Event Reporting Description 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.
 
Arm/Group Title Allo-MSCs Placebo
Hide Arm/Group Description

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)

Buminate solution

Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

All-Cause Mortality
Allo-MSCs Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/20 (5.00%)      0/17 (0.00%)    
Hide Serious Adverse Events
Allo-MSCs Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/20 (25.00%)      11/17 (64.71%)    
Cardiac disorders     
Cardiac failure acute  1  2/20 (10.00%)  2 2/17 (11.76%)  3
Cardiac failure  1  1/20 (5.00%)  1 2/17 (11.76%)  3
Atrial fibrillation  1  1/20 (5.00%)  1 1/17 (5.88%)  1
Ventricular tachycardia  1  1/20 (5.00%)  1 1/17 (5.88%)  1
Cardiovascular deconditioning  1  1/20 (5.00%)  1 0/17 (0.00%)  0
Arrhythmia  1  0/20 (0.00%)  0 1/17 (5.88%)  1
Atrial flutter  1  0/20 (0.00%)  0 1/17 (5.88%)  1
Cardiogenic shock  1  0/20 (0.00%)  0 1/17 (5.88%)  1
Pericardial effusion  1  0/20 (0.00%)  0 1/17 (5.88%)  1
Gastrointestinal disorders     
Chrohn's disease  1  0/20 (0.00%)  0 1/17 (5.88%)  1
Intestinal stenosis  1  0/20 (0.00%)  0 1/17 (5.88%)  1
General disorders     
Sudden cardiac death  1  1/20 (5.00%)  1 0/17 (0.00%)  0
Hepatobiliary disorders     
Drug induced liver injury  1  0/20 (0.00%)  0 1/17 (5.88%)  1
Infections and infestations     
Appendicitis  1  0/20 (0.00%)  0 1/17 (5.88%)  1
Post operative wound infection  1  0/20 (0.00%)  0 1/17 (5.88%)  1
Injury, poisoning and procedural complications     
Procedural pneumothorax  1  1/20 (5.00%)  1 0/17 (0.00%)  0
Fall  1  0/20 (0.00%)  0 1/17 (5.88%)  1
Metabolism and nutrition disorders     
Hyperglycaemia  1  1/20 (5.00%)  1 0/17 (0.00%)  0
Hyponatraemia  1  0/20 (0.00%)  0 1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  1/20 (5.00%)  1 0/17 (0.00%)  0
Nervous system disorders     
Transient ischaemic attack  1  1/20 (5.00%)  1 0/17 (0.00%)  0
Syncope  1  0/20 (0.00%)  0 1/17 (5.88%)  1
Product Issues     
Lead dislodgement  1  0/20 (0.00%)  0 1/17 (5.88%)  1
Device lead damage  1  0/20 (0.00%)  0 1/17 (5.88%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/20 (5.00%)  1 1/17 (5.88%)  1
Reproductive system and breast disorders     
Menorrhagia  1  0/20 (0.00%)  0 1/17 (5.88%)  1
Vascular disorders     
Hypotension  1  1/20 (5.00%)  1 1/17 (5.88%)  1
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Allo-MSCs Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/20 (20.00%)      4/17 (23.53%)    
Cardiac disorders     
Ventricular tachycardia  1  0/20 (0.00%)  0 4/17 (23.53%)  4
Pericardial effusion  1  2/20 (10.00%)  2 0/17 (0.00%)  0
Investigations     
Glomerular filtration rate decreased  1  2/20 (10.00%)  2 0/17 (0.00%)  0
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Heterogeneous history of cancer; Lengthy time interval (both from cancer diagnosis and AIC diagnosis); Age of cancer records (>15 yrs in some cases); Natural history of AIC in our cohort better than expected on the basis of the literature.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shelly Sayre, M.P.H. Project Manager
Organization: University of Texas-Houston School of Public Health
Phone: 713-500-9529
EMail: Shelly.L.Sayre@uth.tmc.edu
Layout table for additonal information
Responsible Party: Barry R Davis, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02509156    
Other Study ID Numbers: HSC-SPH-15-0443
5UM1HL087318 ( U.S. NIH Grant/Contract )
First Submitted: July 23, 2015
First Posted: July 27, 2015
Results First Submitted: September 15, 2020
Results First Posted: November 5, 2020
Last Update Posted: November 5, 2020