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

Phase 2

Completed

• Conditions: Ischemic Cardiomyopathy; Coronary Artery Disease
• Interventions: Procedure: Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).

• Registration Number: NCT01753440
• Lead Sponsor: AHEPA University Hospital

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-20
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem cells implantation	Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).	Patients with severe coronary artery disease and chronic ischemic cardiomyopathy with a LVEF ≤40% who are scheduled for elective CABG according to accepted guidelines. Additional criteria include the following: age \<75 years, history of myocardial infarction (not less than 14 days before the procedure), LVEF ≤40 % assessed with echocardiography, and a distinct area of dyskinetic or akinetic left ventricular myocardium corresponding with the infarct localization.

Primary Outcome Measures

Name	Time	Method
iMP-related adverse events	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	12 months	Hypersensitivity reaction (fever, urticaria, hemolytic anemia, hypotension, immune thrombocytopenia)

Secondary Outcome Measures

Name	Time	Method
LVEF	12 months	Left ventricular ejection fraction
Scar reduction	12 months	Myocardial scar size reduction assess with SPECT
Change in quality of life	12 months	Quality of life evaluated with MLHFQ

Trial Locations

Locations (1)

AHEPA University Hospital; 🇬🇷 Thessaloniki, Greece