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

• Time from randomization to cardiac death [ Time Frame: for an average of 3 years ] [ Designated as safety issue: No ]
• time from randomization to cardiovascular rehospitalisation [ Time Frame: for an average of 3 years ] [ Designated as safety issue: No ]
  time from randomization to cardiovascular rehospitalisation for recurrent MI, coronary revascularisation procedures, heart failure, Implantation of ICD.CRT device, stroke, syncope or Arrhythmias
• incidence and severity of adverse events [ Time Frame: for an average of 3 years ] [ Designated as safety issue: Yes ]
• bleeding by BARC definition [ Time Frame: for an average of 3 years ] [ Designated as safety issue: Yes ]

This is a multinational, multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a single intracoronary infusion of autologous bone marrow-derived mononuclear cells is safe and reduces all-cause mortality in patients with reduced left ventricular ejection fraction(</=45%) after successful reperfusion for acute myocardial infarction when compared to a control group of patients undergoing best medical care.

• Myocardial Infarction
• Death

• No Intervention: standard care
  optimal standard care post myocardial infarction
• Experimental: Intracoronary Reinfusion of Cells
  Bone marrow-derived progenitor cells aspiration and Intracoronary reinfusion of the cells
  Intervention: Procedure: Bone Marrow aspiration and intracoronary reinfusion

Inclusion Criteria:

• men and women of any ethnic origin aged≥18years
• patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI
• Patients with acute ST-elevation myocardial infarction as defined by the universal definition 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 onset followed by successful percutaneous coronary intervention (PCI) within 24 hours after thrombolysis
• Left ventricular ejection fraction ≤ 45% with significant regional wall motion abnormality assessed by quantitative echocardiography (central, independent core lab analysis) 3 to 6 days after reperfusion therapy
• Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion

Exclusion Criteria:

• Participation in another clinical trial within 30 days prior randomisation
• Previously received stem/progenitor cell therapy
• Pregnant or nursing women
• Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
• Necessity to revascularise additional vessels, outside the target coronary artery at the time of progenitor cell infusion (additional revascularisations before, e.g. at the time of acute PCI, are permitted)
• 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 diarrhea within 4 weeks prior screening
• History of 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 uncontrolled neoplastic disease