Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure
NCT ID: NCT00383630
Last Updated: 2019-04-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2007-09-30
2008-12-31
Brief Summary
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Detailed Description
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This study will enroll individuals undergoing surgery to receive an LVAD. Participants will be randomly assigned to one of following three groups:
Group 1 (n=30): participants will undergo intramyocardial injection of bone marrow mononuclear cells (BMCs) during LVAD implantation
Group 2 (n=30): participants will undergo intramyocardial injection of immunoselected CD34+ hematopoietic stem cells during LVAD implantation
Group 3 (n=15): participants will undergo LVAD implantation
Prior to LVAD implantation, participants in Groups 1 and 2 will have a sample of bone marrow removed. Following LVAD implantation, study visits will occur at Days 45 and 90, and then every 60 days thereafter until participants receive a heart transplant. At each visit, participants will undergo a LVAD wean procedure, during which the mechanical pump of the LVAD will be gradually turned off, and the LVAD will be operated with a hand pump. The length of time that a participant tolerates the wean procedure will be evaluated. Heart size and function, blood flow, and nerve function will also be assessed. Some participants will undergo a 6-minute walk test. At the time of heart transplant surgery, the LVAD will be removed, and heart cell regeneration and heart function will be evaluated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Intramyocardial injection of bone marrow mononuclear cells + LVAD
Intramyocardial injection of bone marrow mononuclear cells
6mL of bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.
Group 2
Intramyocardial injection of CD34+ selected bone marrow mononuclear cells + LVAD
Intramyocardial injection of CD34+ selected bone marrow mononuclear cells
6mL of CD34+ selected bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.
Group 3
LVAD alone
LVAD alone
LVAD implantation without any intramyocardial injection of bone marrow cells.
Interventions
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Intramyocardial injection of bone marrow mononuclear cells
6mL of bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.
Intramyocardial injection of CD34+ selected bone marrow mononuclear cells
6mL of CD34+ selected bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.
LVAD alone
LVAD implantation without any intramyocardial injection of bone marrow cells.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Columbia University
OTHER
Responsible Party
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Yoshifumi Naka
Professor of Surgery, Department of Surgery CT
Principal Investigators
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Yoshifumi Naka, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Jewish Hospital
Louisville, Kentucky, United States
Columbia University
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Wisconsin
Madison, Wisconsin, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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