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

AHEPA University Hospital

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease; Ischemic Cardiomyopathy

Treatments: Procedure: Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).

Study type: Interventional

Funder types: Other

Identifiers

NCT01753440

AHEPA_CTL_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Stem cells implantation

Other group

Description:

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.

Treatment:

Procedure: Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).