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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Intramyocardial implantation of a novel mesenchymal precursor cell type (iMP).
AHEPA University Hospital
Thessaloniki, Greece
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.
Time frame: 12 months
Hypersensitivity
Hypersensitivity reaction (fever, urticaria, hemolytic anemia, hypotension, immune thrombocytopenia)
Time frame: 12 months
Scar reduction
Myocardial scar size reduction assessed with SPECT
Time frame: 4 months
Scar reduction
Myocardial scar size reduction assess with SPECT
Time frame: 12 months
LVEF
Left ventricular ejection fraction
Time frame: 12 months
Change in quality of life
Quality of life evaluated with MLHFQ
Time frame: 12 months
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