Myocardial Infarction with reduced Left Ventricular ejection fraction MedDRA version: 14.1 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: autologous bone marrow derived progenitor cells
Product Code: t2c001
Pharmaceutical Form: Suspension for infusion
Sponsors
Queen Mary University London
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 1200
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 randomisation with a minimum of 2 years follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time from randomisation to cardiac death Time from randomisation to cardiovascular death or rehospitalisation due to heart failure Time from randomisation to cardiovascular rehospitalisation for: Recurrent myocardial infarction Coronary revascularization procedures Heart Failure Unplanned implantation of implantable cardioverter defibrillator (ICD)/cardiac resynchronisation therapy (CRT) device after the initial hospitalisation discharge Stroke Safety endpoints are: Incidence of adverse events Incidence of bleeding by bleeding academic research consortium (BARC) definitions Incidence of syncopes Incidence of arrhythmias (atrial fibrillation/ventricular tachycardia) 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 randomisation with a minimum of 2 years follow up. | — |
Countries
Belgium, Czech Republic, Denmark, Finland, Germany, Italy, Netherlands, Spain, United Kingdom
Contacts
Public ContactSheik Dowlut
Queen Mary University London
Outcome results
None listed