Status:
TERMINATED
Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Heart failure is a condition in which the heart is unable to pump enough blood to the body's other organs. A heart transplant may be necessary for some individuals with end-stage heart failure. Left v...
Detailed Description
Congestive heart failure affects 5 million people in the United States, and over 60,000 are diagnosed with end-stage heart failure. Treatment options for these individuals are extremely limited. Becau...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Signed informed consent, release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documents
- Male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as use of oral contraceptive, intrauterine devices, surgical contraception, or a combination of a condom and a spermicide), with negative pregnancy test
- Admitted to the clinical center at the time of study entry
- Listed with United Network for Organ Sharing (UNOS) for cardiac transplantation
- Clinical indication and accepted candidate for implantation of an FDA approved LVAD as a bridge to transplantation
- Hemoglobin between 9.0 gm/dl and 16.1 gm/dl within 24 hours prior to study entry
- Platelet count between 100,000/ul and 450,000/ul within 24 hours prior to study entry
- White blood cell count between 2,500/ul and upper limit of normal within 24 hours prior to study entry
- Exclusion Criteria
- Cardiothoracic surgery within 30 days prior to study entry
- Myocardial infarction within 6 months prior to study entry
- Prior cardiac 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 prior to study entry
- Received investigational intervention within 30 days of study entry
- Pregnant or breastfeeding at time of study entry
- HIV positive within 30 days prior to study entry
- Active systemic infection within 48 hours prior to study entry
Exclusion
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00383630
Start Date
September 1 2007
End Date
December 1 2008
Last Update
April 17 2019
Active Locations (7)
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1
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
2
Jewish Hospital
Louisville, Kentucky, United States, 40202
3
Columbia University
New York, New York, United States, 10032
4
Montefiore Medical Center
New York, New York, United States, 10467