BAMI. The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction

Inclusion Criteria:

• signed and dated informed consent form
• men and women of any ethnic origin aged≥18years
• patients with acute ST-elevation myocardial infarction as defined by the universaldefinition of AMI (including new LBBB)
• Patients with acute ST-elevation myocardial infarction as defined by the universaldefinition of AMI.
• Successful acute reperfusion therapy (residual stenosis visually <50% and TIMI flow ≥2) within 24 hours of symptom onset or thrombolysis within 12 hours of symptom onsetfollowed by successful percutaneous coronary intervention (PCI) within 24 hours afterthrombolysis
• Left ventricular ejection fraction ≤ 45% with significant regional wall motionabnormality assessed by quantitative echocardiography (central, independent core labanalysis) 2 to 6 days after reperfusion therapy
• Open coronary artery suitable for cell infusion supplying the target area of abnormalwall motion

Exclusion Criteria:

• Participation in another clinical trial within 30 days prior randomisation unless noninterventional trials or trials where patients are randomised to only standard careand this has been discussed and agreed with the CI/sponsor prior to consenting
• Previously received stem/progenitor cell therapy
• Pregnant or nursing women
• Mental condition rendering the patient unable to understand the nature, scope andpossible consequences of the study or to follow the protocol
• Necessity to revascularise additional vessels, outside the target coronary artery atthe time of progenitor cell infusion (additional revascularisations after primary PCIand before BM-MNC cell infusion are allowed), unless clinically indicated andaccording to latest guidelines. This decision should be made at the time of the indexprocedure and explicitly stated at that time.
• Cardiogenic shock requiring mechanical support
• Platelet count <100.000/µl, or hemoglobin <8.5 g/dl
• Impaired renal function, i.e. creatinine >2.5 mg/dl
• Fever or diarrhoea not responsive to treatment within 4 weeks prior screening
• Cliinically significant bleeding disorder within 3 months prior screening
• Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg)
• Life expectancy of less than two years from any non-cardiac cause or uncontrolledneoplastic disease