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

Phase 1

• Conditions: Myocardial Infarction with reduced Left Ventricular ejection fraction; MedDRA version: 14.1Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001495-11-IT
• Lead Sponsor: Queen Mary University London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-15
• Study Completion: 2019-11-27
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

1. Signed and dated informed consent
2. Men and women of any ethnic origin aged = 18 years
3. Patients with acute STelevation
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 BMMNC
infusion
(additional revascularisations after primary PCI and before BMMNC
cell infusion are allowed)
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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to assess if the administration of a single injection of patient's own bone marrow derived stem cells into their coronary arteries will reduce all cause mortality.;Secondary Objective: Looking at the time from randomisation to cardiac and cardiovascular events including cardiac death.;Primary end point(s): Time from Randomisation to all-cause-death;Timepoint(s) of evaluation of this end point: The outcome will be assessed at 30 days and every 3 months until the end of the study or up to two years after<br>randomisation with a minimum of 2 years follow up.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time from randomisation to cardiac death<br>Time from randomisation to cardiovascular death or rehospitalisation due to heart failure<br>Time from randomisation to cardiovascular rehospitalisation for:<br>Recurrent myocardial infarction<br>Coronary revascularization procedures<br>Heart Failure<br>Unplanned implantation of implantable cardioverter defibrillator (ICD)/cardiac resynchronisation therapy (CRT)<br>device after the initial hospitalisation discharge<br>Stroke<br>Safety endpoints are:<br>Incidence of adverse events<br>Incidence of bleeding by bleeding academic research consortium (BARC) definitions Incidence of syncopes<br>Incidence of arrhythmias (atrial fibrillation/ventricular tachycardia)<br>Incidence of neoplastic diseases;Timepoint(s) of evaluation of this end point: The outcome will be assessed at 30 days and every 3 months until the end of the study or up to two years after<br>randomisation with a minimum of 2 years follow up.