Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Heart Function in People Receiving an LVAD

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Left ventricular assist devices (LVADs) are one treatment option for people with congestive heart failure. This study will evaluate the safety of injecting mesenchymal precursor cells (MPCs) into the heart during LVAD implantation surgery and examine if injecting MPCs into the heart is effective at improving heart function.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Angioblast Systems; National Heart, Lung, and Blood Institute (NHLBI)

Criteria

Inclusion Criteria:

• Signed informed consent, release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documents

• Age 18 years or older

• If the participant 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 LVAD implantation

• Female participants of childbearing potential must have a negative serum pregnancy test at screening

• Admitted to the clinical center at the time of study entry

• Listed with the United Network for Organ Sharing (UNOS) for heart transplantation

• Clinical indication and accepted candidate for implantation of an FDA- approved LVAD as a bridge to transplantation

Exclusion Criteria:

• Cardiothoracic surgery within 30 days of study entry

• Heart attack within 30 days of study entry

• Prior heart transplantation, left ventricular (LV) reduction surgery, or cardiomyoplasty

• Acute reversible cause of heart failure (e.g., myocarditis, profound hypothyroidism)

• Anticipated requirement for biventricular mechanical support

• Stroke within 30 days of study entry

• Received investigational intervention within 30 days of study entry

• Platelet count less than 100,000/uL within 24 hours of study entry

• Active systemic infection within 48 hours of study entry

• Presence of greater than 10% anti-human leukocyte antigen (HLA) antibody titers with known specificity to the MPC donor HLA antigens

• 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)

• Treatment and/or an incompleted follow-up treatment of any investigational therapy within 6 months of study entry

• Active participation in other research therapy for cardiovascular repair/regeneration

• Prior recipient of stem precursor cell therapy for cardiac repair

• Pregnant or breastfeeding at the time of study entry