Stem Cell Therapy in Patients With Severe Heart Failure & Undergoing Left Ventricular Assist Device Placement
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if the delivery of cells just after implantation of
      left ventricular assist device will help to improve the pumping function of your heart and
      minimize heart enlargement in the future.

      The cells will be obtained by aspiration or withdrawal of fluid from your bone marrow from
      your pelvic bone using a needle and syringe. This would not take place until 24-48 hours
      prior to your planned left ventricular assist device implantation. During the surgery the
      surgeons will inject the prepared cells that were taken from your bone marrow and inject it
      into your heart muscle.

      This study will test whether receiving your own bone marrow cells directly into your heart
      will help your heart to recover function after placement of a left ventricular assist device.
    

Detailed description: 
      Patients who meet the inclusion and exclusion criteria and agree to participate will be
      enrolled in the study. All the patients will have a baseline EKG, Laboratory tests, 2D ECHO
      and PET/CT imaging.Day prior to the LVAD implantation all the patients will undergo bone
      marrow aspiration. Bone marrow aspirate will be processed according to the protocols used by
      that facility. After processing, the bone marrow mononuclear cells will then be suspended in
      2ml of 5% human serum albumin and labeled per the standard protocol of the facility.

      Patients will be randomized in a 2:1 fashion either to receive cells or 5% serum albumin.
      Under general anesthesia using the standard techniques the HeartMate II (LVAD) will be
      placed. The LVAD will be inserted into the LV apex (with removal of 2 x 2 cm ventricular
      core). The tissue core will be processed for RNA isolation and morphological analysis. CV
      surgeon will inject either the cells or placebo directly in to the myocardium in the LAD
      territory. Ten separate injections will be delivered into the LV free wall (20 X 106 cells /
      400 micro lit). The injection sites will be marked with Titanium surgical clips. Subjects
      will be managed at all times by the current standard of care in this hospital for the
      patients with an LVAD. Routine postoperative care procedures will be followed with close
      follow-up for dysrrhythmias or signs of infection.

      Tissue sample from the core of the left ventricular apex removed at the time of implantation
      of LVAD will be compared with the myocardium (marked with the surgical clips) from the
      explanted heart at the time of transplantation. These samples from the experimental subjects
      and control hearts will be examined for morphology for interstitial fibrosis, hypertrophy,
      myocyte diameter and myocytolysis as well as for gene expression using RT-PCR.

      Research-related follow-up will take place at weeks 2, 4, 6, 8 and months 6, 12, 18 and 24
      after LVAD implant at the Clinical Trial Center of the Cardiology Division at the University
      of Minnesota. Patients will be examined by the PI or Sub-I at each visit. Follow up data to
      be obtained at these clinic visits is outlined in the protocol
    

Intervention name(s): Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells
Intervention type(s): Biological
Intervention description(s): Ten separate injections will be delivered into the LV free wall (20 X 106 cells / 400 micro lit).
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart failure; Left ventricular assist device; Stem cells