Autologous Stem Cells for Cardiac Angiogenesis (FOCUS HF)
Condition: Ischemic Cardiomyopathy
MeSH terms: Cardiomyopathies
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, single-blind trial to evaluate using autologous bone marrow mononuclear
      stem cells in ischemic cardiomyopathy patients. The patients must have a Left Ventricular
      Ejection Fraction (LVEF) of less than or equal to 45%. Once the patient meets all inclusion
      criteria, and no exclusion criteria are found, the subject is consented for the study, and
      extensive baseline testing is performed at St Luke's Hospital in Houston. Once all baseline
      testing criteria is met, the patient has their own bone marrow harvested and later that day
      the subject is taken to a cardiac catheterization lab where left ventricular
      electromechanical mapping using NOGA software (NOGA mapping) is performed and the processed
      stem cells are injected under electromechanical guidance into the affected areas of the left
      ventricle. The patient is usually discharged home the next day and returns for follow up
      visits at weeks 1, 2, 4, 6, 8, 12, months 6 and 12 and for phone call follow-up at months 4,
      5, 7, 8, 9, 10, 11. Patients undergo extensive testing at most of these follow-up visits,
      including repeat cardiac catheterization with NOGA mapping at month 6 after stem cell
      injection.
    

Detailed description: 
      This is a phase 1, single-blind trial to evaluate the use of autologous bone marrow
      mononuclear stem cells in ischemic cardiomyopathy patients. The study hypothesis is that
      transendocardial injections of autologous mononuclear bone marrow cells in patients with
      end-stage ischemic heart disease is safe, can promote neovascularization, and can improve
      perfusion and myocardial contractility. The primary object of this study will be to evaluate
      the safety of autologous-bone-marrow mononuclear cell injections. The secondary endpoint of
      the study is to assess the efficacy of autologous bone marrow cells in improving cardiac
      contractile function and functional outcome. The efficacy will be assessed on the basis of
      the treadmill Max VO2 (maximum volume oxygen uptake). Secondarily the efficacy will be
      assessed on the basis of clinical status and imaging rests, with follow-up extending to 1
      year after enrollment.A maximum of 30 patients will be enrolled in the study. At the end of
      the 6-month visit. after the required angiogram with mapping and non-invasive testing is
      complete, the patients will be told whether they were in the control or the active group
      (stem cell therapy). Those in the control group will be told before final invasive testing,
      and those who consent may cross over to the active therapy arm and undergo the cell injection
      procedure (control, then stem cell therapy. In these patients, the foll-up angiogram and
      mapping procedure will also serve as the baseline procedure required for cell injection. Bone
      marrow mononuclear cells will be injected in an identical fashion, according to the same
      criteria described for the original treatment group, and these patients will have identical
      follow-up visits starting again at the baseline time-point and extending for up to 1 year.
    

Intervention name(s): Intramyocardial Injection of stem cells via NOGA Mapping; Control, then Stem Cell Therapy
Intervention type(s): Device; Other
Intervention description(s): Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping to deliver cells in the active arm of the protocol.; Subject is randomized to receive a NOGA mapping and no injections (sham treatment)at time of active enrollment and treatment then offered stem cell therapy at 6 months.
Other intervention name(s): NOGA Star catheter and Myostar Injection.; cross-over
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Autologous; Cardiac; Stem Cell; Transplant