A Study of Allogeneic Low Oxygen Mesenchymal Bone Marrow Cells in Subjects With Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety, tolerability and preliminary efficacy of
      human allogeneic ischemia tolerant mesenchymal bone marrow cells (aLoOxMBMC) administered
      intravenously to subjects with Acute Myocardial Infarction (STEMI, non STEMI).
    

Detailed description: 
      Cardiovascular disease (CVD) remains a leading cause of morbidity and mortality despite
      continuing advances in various treatment options. In developed countries, ischemic heart
      disease causes more than 50% of all cardiovascular deaths.

      Stem cell transplantation has the potential to repair and improve cardiac function, thus
      helping to significantly decrease morbidity and mortality rates. Preclinical data from a
      variety of animal studies demonstrated the capacity for skeletal myoblasts to engraft, form
      myotubules, and enhance cardiac function after transplantation into infarcted myocardium. The
      underlying sequela of the post infarcted left ventricle often includes massive damage to the
      cardiomyocyte. The left ventricle remodeling (dilation) and dysfunction is thought to be
      irreversible. The development of treatments that will regenerate its musculature and vascular
      components is now considered a main therapeutic challenge. Preliminary human studies focusing
      on subjects with ischemic heart disease have demonstrated successful myoblast transplantation
      into the post infarction scar. Another study demonstrated the benefits of stem cell therapy
      on ventricular function and profusion.

      Allogeneic mesenchymal stem cells have been used in a number of clinical trials for different
      indications. These clinical trials showed excellent safety, reduction in arrhythmias,
      improvement in functional status and increased ejection fraction.

      The hMSCs are able to:

        1. Prevent reperfusion injury;

        2. Prevent excessive fibrosis;

        3. Reestablish function of hibernating cardiomyocytes in peripheral zone area.

        4. Reestablish angiogenesis/vasculogenesis;

        5. Preserve wall motion (prevent arrhythmia and functional contractile deterioration);

        6. Prevent post infarct ventricular remodeling and left ventricular dilation. It is well
           accepted that dilated cardiomyopathy mortality rates are 50% within 5 years of
           diagnosis;

        7. Limit infarct size. If we can preserve and restore cardiac function as measured by
           ejection fraction and LVESV preserving left ventricular integrity would increase subject
           quality of life as well as longevity.
    

Intervention name(s): Stem cells; Placebo
Intervention type(s): Biological; Other
Intervention description(s): human Allogeneic Low Oxygen mesenchymal stem cells; Ischemia tolerant; Lactated Ringer's Solution
Other intervention name(s): Allogeneic Low Oxygen mesenchymal stem cells
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: AMI, hBMMSCs, stem cells,