CompletedPhase 2

Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy

Greece11 participantsStarted 2012-11

Plain-language summary

The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of a novel mesenchymal precursor cell type (iMP) in patients with ischemic cardiomyopathy at the time of coronary artery bypass grafting.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age from 18 to 75 years * Severe coronary artery disease amenable to surgical revascularization according to current guidelines * History of acute myocardial infarction at least 14 days previously * Left ventricular ejection fraction (LVEF) ≤ 40% as assessed with echocardiography * Distinct area of dyskinetic or akinetic left ventricular myocardium corresponding with the infarct localization * Patient's informed consent obtained Exclusion Criteria: * Emergency operation * Debilitating chronic disease (eg. malignancy or terminal renal failure) * Concomitant valve surgery * Previous cardiac surgery * Malignant ventricular arrhythmias * Haematologic disease * Woman in reproductive age * Severe psychiatric illness

What they're measuring

iMP-related adverse events

Timeframe: 12 months

Hypersensitivity

Timeframe: 12 months

Trial details

NCT IDNCT01753440

SponsorAHEPA University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09

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