Last updated on February 2010

Safety Study of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Recent Acute Myocardial Infarction


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Myocardial Infarction
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Age 18 years or older.
    An ST-elevation MI (STEMI) within 2 to 10 days of study enrollment. The STEMI must be
    documented by ECG with ST-segment elevation >1 mm in at least 2 contiguous precordial
    leads or in at least 2 adjacent limb leads. If there is a history of a previous AMI
    prior to the qualifying MI, then there must be a documented EF ≥ 50% by 2D
    echocardiogram within 12 months of enrollment.
    Successful percutaneous revascularization with Thrombolysis in Myocardial Infarction
    (TIMI)-3 flow of the infarct-related artery.
    A baseline 2D echocardiogram with EF ≥ 30 and ≤ 50% following PCI.
    Creatinine level ≤ 1.5mg/dL within 24 hours of study procedure.
    Hematocrit ≥ 30% within 24 hours of study procedure.
    White Blood Cell count < 20k/mm3 within 24 hours of study procedure.
    Platelet count ≥ 100k/mm3 within 24 hours of study procedure.
    INR ≤ 1.7 within 24 hours of study procedure.
    Total bilirubin <3 mg/dL, albumin >2.8 g/dL, aspartate aminotransferase(AST) ≤ 2.5x
    the upper limit of normal, gamma glutamyltranspeptidase (GGT) ≤ 1.5 x the upper limit
    of normal.
    If the subject or partner is of childbearing potential, he or she must be willing to
    use adequate contraception (hormonal or barrier method or abstinence) from the time
    of screening and for a period of at least 16 weeks after surgery.
    Female subjects of childbearing potential must have a negative serum pregnancy test
    at screening (within 2 weeks of enrollment) and a negative serum or urine pregnancy
    test on the day of cell implantation.
    Willing and able to understand, sign, and date the Informed Consent Form (ICF).
    Must be willing to return for required follow-up visits.
    Must be able to follow postoperative management program.

You may not be eligible for this study if the following are true:

  • Subject is hemodynamically unstable at Day 5 post-AMI as demonstrated by any of the
    following:
    Killip Class 4 indicative of cardiogenic shock.
    Requirement of intra-aortic balloon pump or IV inotropic support for the
    maintenance of mean arterial blood pressure ≥ 60 mmHg.
    Sustained ventricular tachycardia as demonstrated by QRS complexes wider than 120
    msec, lasting >30 secs, and >100 bpm occurring >48 hours following PCI without any
    identifiable, reversible cause (ie, electrolyte imbalance).
    Further revascularization planned for the next 30 days.
    Chronic atrial fibrillation.
    A wall thickness in the target region <8 mm as determined by 2D echocardiography(the
    target region is defined at the time of NOGA® mapping).
    An LV thrombus.
    Severe peripheral vascular disease precluding femoral artery access as determined at
    time of original catheterization.
    Aortic stenosis as determined as valve area less than 1 cm2 that prohibits catheter
    access to the LV.
    Echocardiographic evidence of hypertrophic cardiomyopathy indicating heart muscle
    thickness >15 mm.
    Human immunodeficiency virus (HIV)
    Serum glucose level ≥ 400 mg/dl within 24 hours of study procedure
    Serum glucose level 300-400 mg/dl and presence of urine ketones within 24 hours of
    tudy procedure.
    Claustrophobic, or with medical conditions or contradictions that impede performing
    baseline MRI study.
    An active uncontrolled infection.
    A prosthetic aortic valve.
    Presence of ≥ 20% anti-HLA antibody titers and/or having antibody specificities to
    donor HLA antigens.
    A current or prior history within the last 3 years of neoplasm (excluding basal cell)
    and/or any active neoplasm within the last 24 months.
    A known hypersensitivity to dimethyl sulfoxide (DMSO), murine and/or bovine products.
    Pregnancy or breastfeeding.
    Imprisoned at the time of enrollment.
    A treatment and/or an uncompleted follow-up treatment of any investigational therapy
    within 6 months before implantation surgery and intent to participate in any other
    investigational drug or cell therapy study during the 3-year follow-up period of this
    tudy.
    Active participation in other research therapy for cardiovascular
    repair/regeneration.
    A prior recipient of stem precursor cell therapy for cardiac repair.
    Any medical condition that would affect the investigator's ability to evaluate the
    ubject's condition or could compromise the subject's safety.
    Any condition that, in the judgment of the investigator, would prohibit the subject
    from participating in the study.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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