NCT01569178CompletedPhase 3
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 London33 sites in 10 countries375 target enrollmentStarted: September 1, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 375
- Locations
- 33
- Primary Endpoint
- Time from randomization to all-cause death
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
The advanced therapy treatment product used in this trial is open label, hence no masking
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
standard care
No Intervention
optimal standard care post myocardial infarction
Intracoronary Reinfusion of Cells
Experimental
Bone marrow-derived progenitor cells aspiration and Intracoronary reinfusion of the cells
Intervention: Bone Marrow aspiration and intracoronary reinfusion (Procedure)
Outcomes
Primary Outcomes
Time from randomization to all-cause death
Time Frame: for an average of 3 years
Secondary Outcomes
- Time from randomization to cardiac death(for an average of 3 years)
- time from randomization to cardiovascular rehospitalisation(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)
Investigators
Anthony Mathur
Clinical Director
Queen Mary University of London
Study Sites (33)
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