Combination Stem Cell (MESENDO) Therapy for Utilization and Rescue of Infarcted Myocardium
Condition: Coronary Artery Disease; Coronary Arteriosclerosis; Coronary Atherosclerosis; Coronary Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis; Arteriosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to determine if the transplant of a combination of stem
      cells, obtained from the bone marrow of the same patient, is effective for utilization and
      rescue of infarcted myocardium. End points will be the assessment of development of mature
      and stable new blood vessels as well as improvement in cardiac function.

      This, Phase I, single center, prospective, non-randomized, open-label study will evaluate the
      safety and feasibility of use of the proposed combination of autologous stem cells. Potential
      subjects who fulfill clinical and laboratory entry criteria at screening will undergo a
      process of bone marrow aspiration for preparation of the two types of bone marrow-derived
      stem /progenitor cells to use. The two bone marrow-derived cell types will be mixed and
      implanted to patients approximately 2 weeks after bone marrow aspiration. After transplant,
      patients will be have a 3 month follow-up to evaluate safety as well as functional heart
      improvement by analysis of symptoms, myocardial perfusion SPECT, and echocardiography.

      Study population will include adult male and female subjects, ages 18-70, presenting with
      acute myocardial infarction and subjects who have had a recent (within 12 months) myocardial
      infarction and will undergo coronary artery bypass grafting.

      Patients will be divided in two groups:

        -  the first group will enroll patients with acute myocardial infarction whom percutaneous
           coronary intervention restored myocardial flow after 4 hours or greater of the
           initiation of symptoms,

        -  the second group will enroll patients who are candidates for coronary artery bypass
           surgery and had a myocardial infarction in the past 12 months.

      Patients will receive the cell mixture by intracoronary or intramyocardial infusion,
      respectively.

      The rationale of this clinical study is based on the observation that most attempts using
      adult stem cells for myocardial regeneration have utilized a source of bone marrow derived
      progenitor cells with the potential to generate new blood vessel and thus contribute to the
      revascularization of the ischemic tissue. This therapy seems to be adequate but not
      sufficient, since it lacks a source of stem cells capable of differentiating and maturing
      into cardiac muscle cells, thus contributing to the recovery of local contractility. The
      proposed combination stem/progenitor cell therapy to be used in this protocol is aimed at
      contributing cell types capable of regenerating both blood vessels and muscle tissues damaged
      after MI.
    


Intervention name(s): MESENDO; MESENDO
Intervention type(s): Biological; Biological
Intervention description(s): Intracoronary transplantation of autologous stem cells via balloon catheter; Intracardiac transplantation of autologous stem cells via direct injection
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myocardial Infarction; Heart Attack; Coronary Artery Bypass Grafting