Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction

• 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:

  • Acute PCI with stent implantation for acute ST elevation MI for either denovo lesions or in-stent thrombosis
  • Treatment with thrombolysis followed by PCI with stent implantation.
• Acute PCI / stent implantation has been successful (residual stenosis visually \< 30% and TIMI flow ≥ 2).
• At the time of inclusion (≥ 1 day post PCI) patient does no longer require i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
• Significant regional wall motion abnormality on echocardiography at the time of acute PCI (ejection fraction ≤ 50% on visual estimation).
• Maximal cardiac troponin elevation ≥ 4 (measured at 37° C)
• 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 acutely revascularize additional vessels, outside the infarct artery.
• Arteriovenous malformations or aneurysms
• Active infection 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 g/dl)
• Platelet count \< 100,000/µl
• Hypersplenism
• History of bleeding disorder
• Gastrointestinal bleeding within 3 months
• Major surgical procedure or trauma within 2 months
• Uncontrolled hypertension
• Pregnancy
• Mental retardation
• Previously performed stem / mononuclear cell therapy
• Participation in another clinical trial within the last 30 days