Status:
TERMINATED
Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Heart Function in People Receiving an LVAD
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Angioblast Systems
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Congestive heart failure is a major health problem and recent estimates indicate that end-stage heart failure with a 2-year mortality rate of 70-80% affects over 60,000 people in the United States eac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00927784
Start Date
August 1 2009
End Date
February 1 2011
Last Update
March 5 2019
Active Locations (17)
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1
Sharp Memorial Hospital
San Diego, California, United States, 92123
2
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
4
Jewish Hospital
Louisville, Kentucky, United States, 40202