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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Coronary Artery Disease, Ischemic Cardiomyopathy

Intervention / Treatment
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* Procedure: Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Stem cells implantation<br>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. | Procedure: Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).<br>* Intramyocardial implantation of a novel mesenchymal precursor cell type (iMP).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iMP-related adverse events | 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. | 12 months | 
| Hypersensitivity | Hypersensitivity reaction (fever, urticaria, hemolytic anemia, hypotension, immune thrombocytopenia) | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, heart failure, stem cells implantation