EUCTR2012-001495-11-BEActive, not recruitingPhase 1
The effect of intracoronary reinfusion of bone marrow-derived mononuclear cells (BMMNC) on all causemortality in acute myocardial infarction - BAMI
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Queen Mary University London
- Enrollment
- 375
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Signed and dated informed consent
- •2. Men and women of any ethnic origin aged = 18 years
- •3. Patients with acute ST-elevation (including new LBBB) myocardial infarction as defined by the universal definition of AMI.
- •4. 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
- •5. 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
- •6. Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1800
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1200
Exclusion Criteria
- •1. Participation in another clinical trial within 30 days prior to randomisation
- •2. Previously received stem/progenitor cell therapy
- •3. Pregnant or nursing women
- •4. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
- •5. Necessity to revascularise additional vessels, outside the target coronary artery at the time of BM-MNC infusion (additional revascularisations after primary PCI and before M-MNC cell infusion are allowed), unless clnically indicated and according to latest guidelines, this decision should be made at the time of the index procedure and explicitly stated at the time
- •6. Cardiogenic shock requiring mechanical support
- •7. Platelet count <100,000/µl, or hemoglobin <8.5 g/dl
- •8. Impaired renal function, i.e. serum creatinine >2.5 mg/dl
- •9. Persistent fever or diarrhea not responsive to treatment within 4 weeks prior screening
- •10. Clinically significant bleeding within 3 months prior screening
- •11. Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg)
- •12. Life expectancy of less than 2 years from any non-cardiac cause or neoplastic disease
Investigators
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