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

Queen Mary University of London

Status and phase

Completed

Phase 3

Conditions

Death

Myocardial Infarction

Treatments

Procedure: Bone Marrow aspiration and intracoronary reinfusion

Study type

Interventional

Funder types

Other

Identifiers

NCT01569178

BAMI-01

Details and patient eligibility

About

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.

Enrollment

375 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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