The effect of intracoronary reinfusion of bone marrow-derived mononuclear cells (BMMNC) on all causemortality in acute myocardial infarctio

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Signed and dated informed consent
2. Men and women of any ethnic origin aged >= 18 years
3. Patients with acute STelevation (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

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 BMMNC infusion (additional revascularisations after primary PCI and before BMMNC cell infusion are allowed), unless clinically indicated and according to latest guidelines. This decision should be madfe 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 noncardiac
cause or neoplastic disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Time from randomisation to all-cause death</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy endpoints:<br /><br>• Time from randomisation to cardiac death<br /><br>• Time from randomisation to cardiovascular death or<br /><br>rehospitalisation due to heart failure<br /><br>• Time from randomisation to cardiovascular<br /><br>rehospitalisation for:<br /><br>Recurrent MI<br /><br>Coronary revascularisation procedures<br /><br>Heart Failure<br /><br>Unplanned implantation of ICD/CRT device after the<br /><br>initial hospitalisation discharge<br /><br>Stroke<br /><br>Safety endpoints:<br /><br>• Incidence of adverse events<br /><br>• Incidence of bleeding by BARC definitions<br /><br>• Incidence of syncopes<br /><br>• Incidence of arrhythmias (A-fib/VT)<br /><br>• Incidence of neoplastic diseases</p><br>

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