AutoLogous Human CArdiac-Derived Stem Cell to Treat Ischemic cArdiomyopathy (ALCADIA)
Condition: Congestive Heart Failure; Ischemic Cardiomyopathy; Ventricular Dysfunction
MeSH terms: Heart Failure; Cardiomyopathies; Ventricular Dysfunction; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to evaluate the safety and efficacy on the transplantation of
      autologous human cardiac-derived stem cells (hCSCs) with the controlled release of basic
      fibroblast growth factor (bFGF) to severe refractory heart failure patients with chronic
      ischemic cardiomyopathy concordance with reduced left ventricular dysfunction (15%≦LVEF≦35%).
    

Detailed description: 
      Autologous human stem or progenitor cells of different lineage have been subjected to
      clinical trials in the past to treat patients with ischemic cardiomyopathy. Although human
      stem or progenitor cells transplantation had functional benefits in the recovery in
      experimental myocardial infarction, the major barrier limiting its clinical application is
      the death of the most of the transplanted cells and poor cardiac differentiation in the host
      environment. Using the identical technique as clonally cell isolation from experimental
      animals, we generated human cardiac-derived stem cell (hCSC) enriched Es-marker genes with
      mesenchymal features. hCSCs included in cell populations accelerating proliferation in the
      presence of basic fibroblast growth factor (bFGF) on plastic plates are generated from human
      heart tissues through endomyocardial biopsy. Giving a patient their own hCSCs is an
      investigational procedure that has been approved by the committee of the Ministry of Health,
      Labour, and Welfare of Japan for this study. hCSCs have excellent potential to proliferate
      and regenerate to cardiomyocyte compared with other cells, e.g. myoblasts, bone marrow
      mononuclear cells and bone marrow stem cells, already evaluated in preliminary experiments on
      the repair of injured heart muscle. bFGF possesses properties to promote stem cell
      proliferation, and formation of sufficient microvascular network created by bFGF is critical
      for long-term survival of transplanted donor cells. This will be the first trial on the use
      of autologous hCSCs for the treatment of refractory heart failure with chronic ischemic
      cardiomyopathy. This trial is translational pilot study for looking into the safety and
      efficacy on the use of autologous hCSCs with the controlled release of bFGF using a gelatin
      hydrogel sheet.
    

Intervention name(s): human cardiac stem cells
Intervention type(s): Procedure
Intervention description(s): Single intramyocardial Injection of autologous hCSCs : 20 cites of infarcted myocardium Implantation of gelatin hydrogel sheet incorporating bFGF: 200 microgram. CABG surgery.
Other intervention name(s): human cardiac stem cell (hCSC); human recombinant basic fibroblast growth factor (bFGF); coronary artery bypass grafting (CABG)
Intervention MeSH terms: Mitogens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ischemic cardiomyopathy (ICM)