Heart Failure Clinical Trial
Official title:
Implantation of Autologous CD133+ Stem Cells in Patients Undergoing CABG
Following myocardial infarct, cellular therapy is a potential approach to repopulate the injured myocardium, to treat heart failure and restore cardiac function. The purpose of this study is to assess the safety, feasibility and efficacy of intramyocardial delivery of selected autologous CD133+ bone marrow stem cells at the time of coronary artery bypass grafting in patients with chronic ischemic cardiomyopathy.
CD133+ are well characterized distinct early progenitor group of stem cells that possess
high engraftment, pluripotent and angiogenic capacity and proved to be valuable for cardiac
repair by promoting neovascularization, inhibition of apoptosis and cardiomyogenesis.
The investigators proposed research protocol involves patients with chronic ischemic heart
disease and left ventricular dysfunction undergoing coronary artery bypass grafting (CABG).
In this phase II clinical trial, prospective, randomized, 2 arm, double-blind,
placebo-controlled study, the investigators will assess the safety, feasibility and
functional effect of intra-myocardial injection of highly selected autologous CD133+ bone
marrow stem cells to placebo.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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