REPAIR-AMI: Intracoronary Progenitor Cells in Acute Myocardial Infarction (AMI)

• The study is a double-blind, placebo-controlled, randomized, multicenter trial.
• Patients after an acute myocardial infarction, undergoing successful reperfusion therapy are included.
• All patients undergo bone marrow aspiration 3 to 6 days after the infarction.
• After cell processing, enriched bone marrow-derived progenitor cells or placebo medium is infused direct into the infarct related artery during stop-flow. In addition, a left ventricular angiography is performed.
• After 4 months left ventricular angiography is repeated. The primary endpoint is the difference in change of left ventricular ejection fraction between the two groups.

Inclusion criteria

• Patients with acute myocardial infarction (ST elevation in at least 2 leads >= 0.2 mV in V1,V2 or V3 or >= 0.1 mV in other leads), treated by one of the following procedures

• Either acute PCI with stent implantation within 24 hours after symptom onset or
• treatment with thrombolysis within 12 hours of symptom onset followed by PCI with stent implantation within 24 hours after thrombolysis.
• Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow >= 2).
• At the time of inclusion patient does no longer require i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
• Significant regional wall motion abnormality in LV angiogram at the time of acute PCI (ejection fraction <= 45% on visual estimation).
• Maximal CK elevation >= 400 U/l (measured at 37° C) with significant MB fraction > 6%
• Age 18 - 80 Years
• Written informed consent

Exclusion criteria

• Regional wall motion abnormality outside the area involved in the index acute myocardial infarction.
• Need to revascularize additional vessels, outside the infarct artery.
• Arteriovenous malformations or aneurysms
• Active infection (CRP > 10 mg/dl) now, or fever or diarrhea within last 4 weeks.
• Chronic inflammatory disease
• HIV infection or active hepatitis
• Neoplastic disease without documented remission within the past 5 years.
• Cerebrovascular insult within 3 months
• Impaired renal function (creatinine > 2 mg/dl) at the time of cell therapy
• Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1,5)
• Anemia (hemoglobin < 8.5 mg/dl)
• Platelet count < 100.000/µl
• Hypersplenism
• Known allergy or intolerance to clopidogrel, heparin or abciximab.
• History of bleeding disorder
• Gastrointestinal bleeding within 3 months
• Major surgical procedure or traumata within 2 months
• Uncontrolled hypertension
• Pregnancy
• Mental retardation
• Previously performed stem / progenitor cell therapy
• Participation in another clinical trial within the last 30 days.