Death, Myocardial Infarction
Conditions
Keywords
stem cells, acute myocardial infarction, heart failure, heart attack, bone marrow, intracoronary reinfusion, bone marrow derived mononuclear cells, Left ventricular function improvement, mortality
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.
Interventions
PROCEDUREBone Marrow aspiration and intracoronary reinfusion
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
Sponsors
Queen Mary University of London
Study design
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
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomization to all-cause death | for an average of 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from randomization to cardiac death | for an average of 3 years | — |
| time from randomization to cardiovascular rehospitalisation | for an average of 3 years | 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 | for an average of 3 years | — |
| bleeding by BARC definition | for an average of 3 years | — |
Countries
Belgium, Czechia, Denmark, Finland, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Outcome results
None listed