The Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis Pilot Study (The POSEIDON-Pilot Study)
Condition: Stem Cell Transplantation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The technique of transplanting progenitor cells into a region of damaged myocardium, termed
      cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or
      repair necrotic, scarred, or dysfunctional myocardium. Ideally, graft cells should be readily
      available, easy to culture to ensure adequate quantities for transplantation, and able to
      survive in host myocardium; often a hostile environment of limited blood supply and
      immunorejection. Whether effective cellular regenerative strategies require that administered
      cells differentiate into adult cardiomyocytes and couple electromechanically with the
      surrounding myocardium is increasingly controversial, and recent evidence suggests that this
      may not be required for effective cardiac repair. Most importantly, transplantation of graft
      cells should improve cardiac function and prevent adverse ventricular remodeling. To date, a
      number of candidate cells have been transplanted in experimental models, including fetal and
      neonatal cardiomyocytes, embryonic stem cell-derived myocytes, tissue engineered contractile
      grafts, skeletal myoblasts, several cell types derived from adult bone marrow, and cardiac
      precursors residing within the heart itself. There has been substantial clinical development
      in the use of whole bone marrow and skeletal myoblast preparations in studies enrolling both
      post-infarction patients, and patients with chronic ischemic left ventricular dysfunction and
      heart failure. The effects of bone-marrow derived mesenchymal stem cells (MSCs) have also
      been studied clinically.

      Currently, bone marrow or bone marrow-derived cells represent highly promising modality for
      cardiac repair. The totality of evidence from trials investigating autologous whole bone
      marrow infusions into patients following myocardial infarction supports the safety of this
      approach. In terms of efficacy, increases in ejection fraction are reported in the majority
      of the trials.

      Chronic ischemic left ventricular dysfunction resulting from heart disease is a common and
      problematic condition; definitive therapy in the form of heart transplantation is available
      to only a tiny minority of eligible patients. Cellular cardiomyoplasty for chronic heart
      failure has been studied less than for acute MI, but represents a potentially important
      alternative for this disease.
    


Intervention name(s): Auto-hMSCs; Allo-hMSCs
Intervention type(s): Biological; Biological
Intervention description(s): Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.; Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Ischemic Left Ventricular