Implantation of a Novel Allogeneic Mesenchymal Precursor Cell Type in Patients with Ischemic Cardiomyopathy Undergoing Coronary Artery Bypass Grafting: an Open Label Phase IIa Trial
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Heart failure is a life-limiting condition affecting over 40 million patients worldwide. Ischemic cardiomyopathy (ICM) is the most common cause. This study 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 %). The phase IIa safety study was designed to enroll 11 patients. Preoperative scintigraphy imaging (SPECT) was used to identify hibernating myocardium not suitable for conventional myocardial revascularization for iMP implantation. iMP cells were implanted intramyocardially in predefined viable peri-infarct areas that showed poor perfusion, which could not be grafted due to poor target vessel quality. Postoperatively, SPECT was then used to identify changes in scar area. Intramyocardial implantation of iMP cells with CABG was safe with preliminary evidence of efficacy of improved myocardial contractility and perfusion of nonrevascularized territories resulting in a significant reduction in left ventricular scar area at 12 months after treatment. Clinical improvement was associated with a significant improvement in quality of life at 6 months posttreatment in all patients. The results suggest the potential for in situ myocardial regeneration in ischemic heart failure by delivery of iMP cells.
KeywordsIschemic cardiomyopathy Coronary artery bypass grafting Stem cells Allogeneic Mesenchymal Heart failure
Coronary artery bypass grafting
Institutional review board
Limulus amebocyte lysate
Left ventricular ejection fraction
Major adverse cardiac and cerebrovascular events
Major histocompatibility class
Minnesota Living with Heart Failure Questionnaire
Mesenchymal stem cells
New York Heart Association
Polymerase chain reaction
Single photon emission computed tomography
Tissue inhibitor of matrix metalloproteinase
We would like to thank the molecular biologist Dr Nancy Piouka for her valuable contribution in the preparation and handling of the iMP cells.
Compliance with Ethical Standards
Sources of Funding
This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
AR, MJE, and SS hold shares in Cell Therapy Limited.
Informed consent was obtained from all individual participants included in the study.
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