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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01753440

Enrollment

Registered

2012-12-20

Start date

2012-11-30

Completion date

2014-12-31

Last updated

2019-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Ischemic Cardiomyopathy

Keywords

coronary artery disease, heart failure, stem cells implantation

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.

Interventions

PROCEDUREIntramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Scar reduction	4 months	Myocardial scar size reduction assessed with SPECT
LVEF	12 months	Left ventricular ejection fraction
Change in quality of life	12 months	Quality of life evaluated with MLHFQ

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026