Safety Study of AMI MultiStem® to Treat Heart Attacks

Exclusion Criteria

• •Prior cardiovascular history
• •Mechanical complications of the index acute myocardial infarction including but not limited to rupture of the mitral valve with resultant development of mitral regurgitation, rupture of the left ventricular free wall and rupture of the interventricular septum
• •Pregnant or lactating
• •Known allergy to contrast agents
• •Known allergy or religious objections to bovine or porcine products
• •History of malignancy of any type except non-melanoma skin cancer
• •Presence of major hematological conditions or laboratory abnormalities (low hemoglobin (\<10 gm/dl), - WBC (\<3,000 cells/mm2) or platelet count (\<100,000 cells/mm3))
• •Prothrombin time (PT) \> 1x ULN
• •Partial thromboplastin time (PTT) \> 1x ULN
• •Presence of chronic systemic inflammatory disorders that requires ongoing therapy
• •Previous autologous, allogeneic bone marrow or peripheral stem cell transplant
• •Prior solid organ transplantation
• •Immune system compromise including but not limited to history of human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C (HCV) infection.
• •Prior participation in any other study involving investigational pharmacological agents(s), devices or marketed products within 30 days prior to planned AMI MultiStem® administration
• •Life expectancy of six months or less
• •Current alcohol or substance abuse
• •Ongoing systemic infection
• •Renal function: Serum creatinine \>2 mg/dL or creatinine clearance ≤50 mL/min
• •Hepatic function: Screening ALT and AST ≥3x upper limit of normal for the laboratory or total bilirubin ≥2.0 mg/dL (exception: acceptable if patient is identified with pre existing condition e.g. Gilbert's disease that will contribute to baseline elevations of bilirubin)
• •Other serious medical or psychiatric illness that, in the investigator's opinion, would not permit the patient to be managed according to the protocol.