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

Study Overview
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Brief Summary
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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.

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

Conditions
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Myocardial Infarction, Death

Intervention / Treatment
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* Procedure: Bone Marrow aspiration and intracoronary reinfusion


Participation Criteria
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Eligibility Criteria
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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 universal definition of AMI (including new LBBB) 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) 2 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 unless non interventional trials or trials where patients are randomised to only standard care and 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 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 after primary PCI and before BM-MNC cell infusion are allowed), unless clinically indicated and according to latest guidelines. This decision should be made at the time of the index procedure 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 uncontrolled neoplastic disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard care<br>optimal standard care post myocardial infarction | |
| Experimental: Intracoronary Reinfusion of Cells<br>Bone marrow-derived progenitor cells aspiration and Intracoronary reinfusion of the cells | Procedure: Bone Marrow aspiration and intracoronary reinfusion<br>* Bone marrow-derived progenitor cells are obtained from 50ml bone marrow aspirated under local anaesthesia from the iliac crest. Intracoronary infusion of the cells is performed via conventional percutaneous intracoronary intervention techniques using an over-the-wire balloon technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from randomization to all-cause death |  | for an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from randomization to cardiac death |  | for an average of 3 years | 
| time from randomization to cardiovascular rehospitalisation | time from randomization to cardiovascular rehospitalisation for recurrent MI, coronary revascularisation procedures, heart failure, Implantation of ICD.CRT device, stroke, syncope or Arrhythmias | for an average of 3 years | 
| incidence and severity of adverse events |  | for an average of 3 years | 
| bleeding by BARC definition |  | for an average of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stem cells, acute myocardial infarction, heart failure, heart attack, bone marrow, intracoronary reinfusion, bone marrow derived mononuclear cells, Left ventricular function improvement, mortality