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Trial record 1 of 1 for:    NCT02362646
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Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients

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ClinicalTrials.gov Identifier: NCT02362646
Recruitment Status : Completed
First Posted : February 13, 2015
Results First Posted : November 26, 2019
Last Update Posted : November 26, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Annetine Gelijns, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Heart Failure
Cardiomyopathy
Ventricular Dysfunction
Interventions Biological: MPC Intramyocardial Injection
Drug: Control Solution
Enrollment 159
Recruitment Details Screening started in 2014. First patient randomized in July 2015. Last patient randomized in August 2017.
Pre-assignment Details  
Arm/Group Title MPC Intramyocardial Injection Control Solution
Hide Arm/Group Description MPC Intramyocardial Injection: Intramyocardial injection of 150 million mesenchymal precursor cells (MPCs) at the time of LVAD implantation Control Solution: Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
Period Title: Overall Study
Started 106 53
Completed 68 29
Not Completed 38 24
Reason Not Completed
Death             15             8
Withdrawal by Subject             2             2
received transplant             21             14
Arm/Group Title MPC Intramyocardial Injection Control Solution Total
Hide Arm/Group Description MPC Intramyocardial Injection: Intramyocardial injection of 150 million mesenchymal precursor cells (MPCs) at the time of LVAD implantation Control Solution: Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO Total of all reporting groups
Overall Number of Baseline Participants 106 53 159
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 53 participants 159 participants
55.5  (12.3) 56.9  (11.7) 56  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 53 participants 159 participants
Female
12
  11.3%
6
  11.3%
18
  11.3%
Male
94
  88.7%
47
  88.7%
141
  88.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 53 participants 159 participants
Hispanic or Latino
6
   5.7%
0
   0.0%
6
   3.8%
Not Hispanic or Latino
100
  94.3%
52
  98.1%
152
  95.6%
Unknown or Not Reported
0
   0.0%
1
   1.9%
1
   0.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 53 participants 159 participants
American Indian or Alaska Native
2
   1.9%
0
   0.0%
2
   1.3%
Asian
2
   1.9%
5
   9.4%
7
   4.4%
Native Hawaiian or Other Pacific Islander
1
   0.9%
0
   0.0%
1
   0.6%
Black or African American
16
  15.1%
7
  13.2%
23
  14.5%
White
82
  77.4%
40
  75.5%
122
  76.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   2.8%
1
   1.9%
4
   2.5%
1.Primary Outcome
Title Number of Temporary Weans From LVAD Support Tolerated
Hide Description functional status, defined by the number of temporary weans from LVAD support tolerated over the 6 months post-randomization. A successful wean is the ability to tolerate temporary weaning from LVAD support for 30 minutes without sustained symptoms of worsening heart failure. Wean failures are defined as inability to tolerate the temporary wean for 30 minutes; death; or patient too unstable, in the judgment of the primary heart failure cardiologist, to tolerate the wean attempt.
Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MPC Intramyocardial Injection Control Solution
Hide Arm/Group Description:
MPC Intramyocardial Injection: Intramyocardial injection of 150 million mesenchymal precursor cells (MPCs) at the time of LVAD implantation
Control Solution: Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
Overall Number of Participants Analyzed 106 53
Mean (Standard Deviation)
Unit of Measure: number of weans
0.61  (0.41) 0.58  (0.45)
2.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Safety as assessed by number of study intervention-related adverse events
Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MPC Intramyocardial Injection Control Solution
Hide Arm/Group Description:

Intramyocardial injections of 150 million MPCs

MPC Intramyocardial Injection: Intramyocardial injection of 150 million mesenchymal precursor cells at the time of LVAD implantation

Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO

Control Solution

Overall Number of Participants Analyzed 106 53
Measure Type: Count of Participants
Unit of Measure: Participants
Serious AE
88
  83.0%
44
  83.0%
Other than Serious AE
33
  31.1%
12
  22.6%
3.Secondary Outcome
Title Physiologic Assessments
Hide Description Echocardiographic assessments of the myocardial size and function by transthoracic echocardiography with LVAD at full support, and as tolerated following 6-Minute Walk Test (MWT) while weaned from LVAD support (for patients who tolerate wean from LVAD support for 30 minutes)
Time Frame up to 12 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Histopathological Assessments of Myocardial Tissue
Hide Description [Not Specified]
Time Frame up to 12 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame up to 12 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change in Quality of Life (QoL)
Hide Description Quality of life will be assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), a widely used tool in heart failure populations, and the Short Form 12 (SF12), a widely used overall health status measure.
Time Frame 6 months and 12 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Hopkins Verbal Learning Test
Hide Description Cognitive performance will be assessed Hopkins Verbal Learning Test. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.
Time Frame 3 months and 12 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Trailmaking Tests A and B
Hide Description Cognitive performance will be assessed using Trailmaking Tests A and B. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.
Time Frame 3 months and 12 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title MCG Complex Figures
Hide Description Cognitive performance will be assessed using the MCG Complex Figures. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.
Time Frame 3 months and 12 months
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Digit Span
Hide Description Cognitive performance will be assessed using the MCG Complex Figures. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.
Time Frame 3 months and 12 months
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Digit Symbol Substitution Test
Hide Description Cognitive performance will be assessed using the Digit Symbol Substitution Test. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.
Time Frame 3 months and 12 months
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Controlled Oral Word Association
Hide Description Cognitive performance will be assessed using the Controlled Oral Word Association. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.
Time Frame 3 months and 12 months
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Length of Stay
Hide Description Length of stay of index hospitalization
Time Frame up to 12 months
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Hospitalizations
Hide Description Frequency and cause of readmissions
Time Frame up to 12 months
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Hospital Costs
Hide Description Hospital resource use
Time Frame up to 12 months
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Functional Status
Hide Description functional status, defined by the number of temporary weans from LVAD support tolerated
Time Frame up to 12 months
Outcome Measure Data Not Reported
Time Frame 6 months for adverse events 12 months for mortality
Adverse Event Reporting Description Trial specific protocol-defined adverse event
 
Arm/Group Title MPC Intramyocardial Injection Control Solution
Hide Arm/Group Description

Intramyocardial injections of 150 million MPCs

MPC Intramyocardial Injection: Intramyocardial injection of 150 million mesenchymal precursor cells at the time of LVAD implantation

Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO

Control Solution

All-Cause Mortality
MPC Intramyocardial Injection Control Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   15/106 (14.15%)   8/53 (15.09%) 
Hide Serious Adverse Events
MPC Intramyocardial Injection Control Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   88/106 (83.02%)   41/53 (77.36%) 
Blood and lymphatic system disorders     
Hemolysis  1  4/106 (3.77%)  2/53 (3.77%) 
Venous Thromboembolism Event  1  2/106 (1.89%)  1/53 (1.89%) 
Cardiac disorders     
Sustained ventricular dysrhythmia requiring defibrillation or cardioversion  1  26/106 (24.53%)  8/53 (15.09%) 
Sustained supraventricular dysrhythmia requiring drug treatment or cardioversion  1  12/106 (11.32%)  9/53 (16.98%) 
Right heart failure  1  19/106 (17.92%)  10/53 (18.87%) 
Pericardial Fluid Collection  1  8/106 (7.55%)  3/53 (5.66%) 
Vasodilatory State  1  3/106 (2.83%)  0/53 (0.00%) 
MI (Non-perioperative)  1  1/106 (0.94%)  0/53 (0.00%) 
Sustained SVT dysrhytmia  1 [1]  14/106 (13.21%)  3/53 (5.66%) 
General disorders     
Bleeding  1  51/106 (48.11%)  28/53 (52.83%) 
Potential Inflammatory Responses  1  1/106 (0.94%)  0/53 (0.00%) 
Hepatobiliary disorders     
Hepatic Dysfunction  1  1/106 (0.94%)  1/53 (1.89%) 
Infections and infestations     
Localized nondevice infection  1  20/106 (18.87%)  14/53 (26.42%) 
Sepsis  1  14/106 (13.21%)  6/53 (11.32%) 
Percutaneous site and/or pocket infection  1  6/106 (5.66%)  5/53 (9.43%) 
Localized nondevice infection   16/106 (15.09%)  8/53 (15.09%) 
Injury, poisoning and procedural complications     
Pump thrombus confirmed  1  10/106 (9.43%)  3/53 (5.66%) 
Pump thrombus suspected  1  9/106 (8.49%)  3/53 (5.66%) 
Nonpump thrombus related  1  1/106 (0.94%)  0/53 (0.00%) 
Minor device malfunction  1  2/106 (1.89%)  0/53 (0.00%) 
Wound Dehiscence  1  1/106 (0.94%)  1/53 (1.89%) 
Nervous system disorders     
Toxic metabolic encephalopathy  1  5/106 (4.72%)  4/53 (7.55%) 
Ischemic stroke  1  6/106 (5.66%)  1/53 (1.89%) 
Intracranial hemorrhage  1  6/106 (5.66%)  0/53 (0.00%) 
Transient ischemic attack  1  3/106 (2.83%)  1/53 (1.89%) 
Other neurological dysfunction  1  5/106 (4.72%)  3/53 (5.66%) 
Psychiatric disorders     
Psychiatric Episode  1  1/106 (0.94%)  0/53 (0.00%) 
Renal and urinary disorders     
Renal dysfunction  1  10/106 (9.43%)  5/53 (9.43%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure  1  16/106 (15.09%)  10/53 (18.87%) 
Pleural Effusion  1  13/106 (12.26%)  6/53 (11.32%) 
Pleural Effusion   6/106 (5.66%)  3/53 (5.66%) 
Vascular disorders     
Hypertension  1  4/106 (3.77%)  1/53 (1.89%) 
Arterial Non-CNS Thromboembolism  1  1/106 (0.94%)  0/53 (0.00%) 
1
Term from vocabulary, CTCAE (unspecified)
Indicates events were collected by systematic assessment
[1]
Sustained supraventricular dysrhythmia requiring drug treatment or cardioversion
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MPC Intramyocardial Injection Control Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   33/106 (31.13%)   12/53 (22.64%) 
Cardiac disorders     
Sustained supraventricular dysrhythmia  [1]  14/106 (13.21%)  3/53 (5.66%) 
Infections and infestations     
Localized nondevice infection   16/106 (15.09%)  8/53 (15.09%) 
Respiratory, thoracic and mediastinal disorders     
Pleural Effusion   6/106 (5.66%)  3/53 (5.66%) 
Indicates events were collected by systematic assessment
[1]
Sustained supraventricular dysrhythmia requiring drug treatment or cardioversion
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Annetine Gelijns, PhD
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-659-9567
EMail: annetine.gelijns@mssm.edu
Layout table for additonal information
Responsible Party: Annetine Gelijns, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02362646    
Other Study ID Numbers: GCO 08-1078-0008
2U01HL088942-07 ( U.S. NIH Grant/Contract )
First Submitted: February 9, 2015
First Posted: February 13, 2015
Results First Submitted: November 7, 2019
Results First Posted: November 26, 2019
Last Update Posted: November 26, 2019