Study on the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Implantation Combined With Bypass Grafting in Patients With Coronary Artery Disease and Ischemic Cardiomyopathy.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- AHEPA University Hospital
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- iMP-related adverse events
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed Description
This study aims to investigates in situ cardiac regeneration utilizing precision delivery of a novel mesenchymal precursor cell type (iMP) during coronary artery bypass surgery (CABG) in patients with ischemic cardiomyopathy (LVEF \< 40 %). Preoperative scintigraphy imaging (SPECT) will be used to identify hibernating myocardium not suitable for conventional myocardial revascularization for iMP implantation. iMP cells will be implanted intramyocardially in predefined viable peri-infarct areas that show poor perfusion, which could not be grafted due to poor target vessel quality. Postoperatively, SPECT will be used to identify changes in scar area.
Investigators
Kyriakos Anastasiadis
Professor Kyriakos Anastasiadis
AHEPA University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
iMP-related adverse events
Time Frame: 12 months
Major adverse cardiac and cerebrovascular events including death, postoperative myocardial infarction, need for revascularization, stroke, hospitalization for worsening heart failure, myocardial rupture, infectious myocarditis, or sustained ventricular arrhythmias.
Hypersensitivity
Time Frame: 12 months
Hypersensitivity reaction (fever, urticaria, hemolytic anemia, hypotension, immune thrombocytopenia)
Secondary Outcomes
- Change in quality of life(12 months)
- LVEF(12 months)
- Scar reduction(12 months)