- Trial ID:
- Richard Schatz
- 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).
- 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.
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.
- 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).
- Tom Moss, MD