NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial Infarction

Exclusion Criteria

• •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.