The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in Patients Undergoing LVAD Implantation

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Left Ventricular Assist Device, Heart Transplantation, Cardiomyopathy, Destination Therapy, Cell Therapy Read More

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 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;
• Cardiothoracic surgery within 30 days prior to randomization;
• Myocardial infarction 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;
• Active systemic infection within 48 hours prior to randomization;
• Presence of >10% anti-human leukocyte antigen (anti-HLA) antibody titers with known specificity to the MPC donor HLA antigens;
• A known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or bovine products;
• History of cancer prior to screening (excluding basal cell carcinoma);
• Acute or chronic infectious disease, including but not limited to human immunodeficiency virus (HIV);
• Received investigational intervention within 30 days prior to randomization;
• Treatment and/or an incompleted 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.