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

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

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.

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.

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