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  • PRESERVE AMI Trial

  • Principal Investigator:  Paul Gordon, MD
    Sponsored by:  Amorcyte, LLC
     
    A prospective randomized double blinded placebo-controlled Phase II trial of intra-coronary infusion of AMR001, a bone marrow derived autologous CD34+ selected cell product in patients with acute myocardial infarction. 

    Eligibility:
    • Patients who have had an myocardial infarction and have suffered damage to the heart muscle
     
    Participation Includes:
    • Standard blood tests
    • Clinic visits 
    • Phone call follow ups
    • Mini bone marrow harvest and infusion
    • Stem cells
    • Participation in this study will be 3 years
     
    Pre-clinical and clinical data clearly demonstrate that following a myocardial infarction the acute loss of myocardial muscle cells and the accompanying peri-infarct zone hypo-perfusion result in a cascade of events causing an immediate decrement in cardiac function that has the potential to persist long term. Despite revascularization of the infarct related artery circulation and appropriate medical management to minimize ventricular wall stresses, a significant percentage of subjects experience adverse ventricular remodeling, permanent cardiac dysfunction and consequently remain at an increased life-time risk of experiencing adverse cardiac events, including death.
     
    The primary objective of the study is to determine safety and the effect of intracoronary infusion of AMR-001 on myocardial perfusion using the resting total severity score (RTSS), measured by gated SPECT MPI at baseline and six months, in subjects with STEMI.
     
    This will be a multi-center, randomized, double blind, placebo-controlled clinical trial to evaluate the efficacy and safety of IRA infusion of AMR-001 after STEMI in subjects with ejection fraction ≤48%, as determined by CMR 96 hours or more post stent placement. 160 subjects, 18 years of age or older, will be randomized 1:1 to treatment and controls, up to 80 in the treatment group and up to 80 in the control group.
     

    Contact Information:
    Cardiovascular Research
    The Miriam Hospital
    Lori-Ann DeSimone, RN
    401-793-4105