Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients

Annetine Gelijns

Status and phase

Completed

Phase 2

Conditions

Cardiomyopathy

Ventricular Dysfunction

Heart Failure

Treatments

Drug: Control Solution

Biological: MPC Intramyocardial Injection

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02362646

GCO 08-1078-0008

2U01HL088942-07 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

159 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Acute infectious process: acute bacterial, fungal, or viral disease OR acute exacerbation of chronic infectious disease such as hepatitis
Presence of >10% anti-HLA antibody titers with known specificity to MPC donor HLA antigens
A known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or bovine products
History of a known active malignancy within the past 3 years except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that has been definitively treated
Presence of human immunodeficiency virus (HIV)
Received investigational intervention within 30 days prior to randomization
Treatment and/or an incomplete follow-up treatment of any investigational cell based therapy within 6 months prior to randomization
Active participation in other research therapy for cardiovascular repair/regeneration
Prior recipient of stem precursor cell therapy for cardiac repair
Pregnant or breastfeeding at time of randomization.
History of known or suspected hypercoagulable state in the opinion of the investigator