Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Intervention: Intramyocardial injection of bone marrow mononuclear cells; Intramyocardial injection of CD34+ selected bone marrow mononuclear cells; LVAD alone
Intervention description: 6mL of bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.; 6mL of CD34+ selected bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.; LVAD implantation without any intramyocardial injection of bone marrow cells.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: End Stage Heart Failure; LVAD; Bone Marrow Transplantation; Stem Cell Transplantation

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 ventricular assist devices (LVADs) can assist the heart in pumping blood, and
      are commonly used until a donor heart becomes available. Bone marrow cells injected into the
      heart may improve heart function and may lead to earlier LVAD removal. The purpose of this
      study is to evaluate the safety and effectiveness of injected bone marrow cells in improving
      heart function in individuals with LVADs who are awaiting heart transplants.
    

Eligibility criteria:

        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