Clinical Study Protocol: Amorcyte Study-002 Title: A Prospective Randomized Double Blinded Placebo Controlled Phase II Trial of Intra-coronary Infusion of AMR-001, a Bone Marrow Derived Autologous CD34+ Selected Cell Product, in Patients with Acute Myocardial Infarction.[Protocol:002]

Trial ID:
Richard Schatz
This study will assess the safety and efficacy of intracoronary artery administered autologous bone marrow derived stem cells in subjects post...

Inclusion Criteria:

  • 1. Age 18 years or older.
  • 2. Acute ST elevation myocardial infarction meeting ACC/AHA criteria, with symptoms of chest pain within 3 days of admission. Criteria include (ST elevation > 1mm in limb leads or 2 mm in two or more precordial leads, and increased levels of troponin, CPK MB or both).
    • Chest pain syndrome can extend to more than 3 days prior to admission if its course is consistent with transient/intermittent ischemia rather than symptoms that are continuous suggesting ongoing infarction extending beyond 3 days.

  • 3. Successful stent placement and reperfusion within 3 days of chest pain onset and with TIMI Flow score of 2 or 3 and infarct related artery (IRA) with <20% stenosis after revascularization.
  • 4. Wall motion abnormality associated with the target lesion
  • 5. NYHA heart failure class I, II or III.
  • 6. Study entry LVEF <48% determined by CMR no sooner than 96 hours from stent placement.
  • 7. Able to provide informed written consent and willing to participate in all required study follow-up assessments.
  • 8. Subjects must have an INR ≤ 2.0 within 2 days of the bone marrow collection.
  • 9. Subjects must have a Hgb ≥ 10 grams/dL, WBC ≥ 3500 cells/mm3, a platelet count ≥ 100,000 cells/mm3, serum creatinine ≤ 2.5, and total bilirubin ≤ 2.0 within 7 days of the bone marrow collection or by end of screening phase.
  • 10. Expected survival of at least one year.
  • 11. Females of child bearing potential agree to use birth control (barrier method accepted) for one month post bone marrow harvest.

    • 1. Continuous/ongoing chest pain - unremitting and unresponsive to nitroglycerin or rest - persisting 4 or more days before stent placement. If the chest pain syndrome is transient and/or intermittent - even if it began more than 3 days prior to admission - the patient is not excluded.
    • 2. Subjects in cardiogenic shock (systolic pressure < 80mm/Hg, on vasopressors, or intra-aortic counterpulsation) at the time of consenting. Subjects who recover from cardiogenic shock by the time of consenting are eligible.
    • 3. Subjects unable to receive antiplatelet agents (e.g. aspirin, clopidogrel, ticlopidine, prasugrel, etc).
    • 4. Subjects receiving warfarin who have an INR >2 or with major bleeding requiring active transfusion support.
    • 5. Subjects who require continuous anticoagulation during the time when the bone marrow harvest is scheduled, as heparin must be discontinued for 4 hours prior to and 24 hours after bone marrow harvest procedure. (See Appendix VII.)
    • 6. Subjects with severe cardiac valvular disease expected to undergo surgery within 1 year.
    • 7. Subjects with known severe immunodeficiency states (AIDS).
    • 8. Cirrhosis requiring active medical management.
    • 9. Malignancy requiring active treatment (except basal cell skin cancer).
  • 10. Subjects with documented active alcohol and /or other substance abuse.
  • 11. Females of child bearing potential unless a pregnancy test is negative within 7 days of the mini-bone marrow harvest.
  • 12. Re-occlusion of the IRA prior to the infusion procedure.
  • 13. Planned revascularization intervention during the next 6 months (A second PCI can be performed if done prior to qualifying CMR at least 96 hours post primary PCI).
  • 14. Participation in an ongoing investigational trial.
  • 15. Active or suspected bacterial infection requiring systemic intravenous antibiotics.
  • Why isn't this trial accepting new patients?

    The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting

    How else can Scripps help me?

    We have a broad range of physician expertise and specialized medical services available. You can find a doctor online, call 1-800-SCRIPPS (1-800-727-4777) for personal help, or see related Scripps services.

    How can I find trials that are accepting new participants?

    For more information, see a list of trials that are recruiting, or call the clinical research office at 800-995-4200 for help.