Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients
Overview
- Phase
- Phase 2
- Intervention
- MPC Intramyocardial Injection
- Conditions
- Heart Failure
- Sponsor
- Annetine Gelijns
- Enrollment
- 159
- Locations
- 19
- Primary Endpoint
- Number of Temporary Weans From LVAD Support Tolerated
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.
Detailed Description
Intramyocardial injection of mesenchymal precursor cells (MPC) in patients with advanced heart failure who are treated with left ventricular assist device (LVAD) implantation may result in a renewable source of proliferating functional cardiomyocytes; induce development of capillaries and larger-size blood vessels to supply oxygen and nutrients to endogenous myocardium and newly-implanted cardiomyocytes; and release factors capable of paracrine signaling.
Investigators
Annetine Gelijns
Chair, Department of Population Health Science & Policy; Edmond A. Guggenheim Professor of Health Policy; Co-Director, InCHOIR
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation
- •Age 18 years or older
- •If the subject or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after procedure
- •Female subjects of childbearing potential must have a negative serum pregnancy test at screening
- •Admitted to the clinical center at the time of randomization
- •Clinical indication and accepted candidate for implantation of an FDA-approved (US sites only) or Health Canada-approved (Canadian sites only) implantable, non-pulsatile LVAD as a bridge to transplantation or for destination therapy.
Exclusion Criteria
- •Planned percutaneous LVAD implantation
- •Anticipated requirement for biventricular mechanical support
- •Concomitant arrhythmia ablation at time of LVAD implantation
- •- Planned aortic valve intervention for aortic insufficiency at the time of LVAD implantation
- •Cardiothoracic surgery within 30 days prior to randomization
- •Spontaneous myocardial infarction related to ischemia due to a primary coronary event such as unstable plaque rupture, erosion or dissection within 30 days prior to randomization
- •Prior cardiac transplantation, LV reduction surgery, or cardiomyoplasty
- •Acute reversible cause of heart failure (e.g. myocarditis, profound hypothyroidism)
- •Stroke within 30 days prior to randomization
- •Platelet count \< 100,000/ul within 24 hours prior to randomization
Arms & Interventions
MPC Intramyocardial Injection
Intramyocardial injections of 150 million MPCs
Intervention: MPC Intramyocardial Injection
Control Solution
Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
Intervention: Control Solution
Outcomes
Primary Outcomes
Number of Temporary Weans From LVAD Support Tolerated
Time Frame: up to 6 months
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.
Number of Participants With Adverse Events
Time Frame: up to 6 months
Safety as assessed by number of study intervention-related adverse events
Secondary Outcomes
- Physiologic Assessments(up to 12 months)
- Functional Status(up to 12 months)
- MCG Complex Figures(3 months and 12 months)
- Digit Span(3 months and 12 months)
- Digit Symbol Substitution Test(3 months and 12 months)
- Change in Quality of Life (QoL)(6 months and 12 months)
- Controlled Oral Word Association(3 months and 12 months)
- Overall Survival(up to 12 months)
- Histopathological Assessments of Myocardial Tissue(up to 12 months)
- Hopkins Verbal Learning Test(3 months and 12 months)
- Trailmaking Tests A and B(3 months and 12 months)
- Hospital Costs(up to 12 months)
- Length of Stay(up to 12 months)
- Hospitalizations(up to 12 months)