Abstract 4141104: Safety and Therapeutic Potential of Allogeneic Adipose-Derived Stem Cell Spray Transplantation in Ischemic Cardiomyopathy: A Phase I Clinical Trial

Background: Ischemic cardiomyopathy, characterized by an imbalance in myocardial blood supply due to coronary artery atherosclerosis, presents a formidable health challenge. Although coronary artery bypass grafting (CABG) can enhance long-term survival, a subset of patients does not exhibit significant improvement in cardiac function post-surgery. This study investigated the safety and therapeutic potential of allogeneic adipose-derived stem cell (ADSC) spray transplantation combined with CABG in ischemic cardiomyopathy. Methods: This single-center, double-blind, randomized clinical trial included six eligible patients with ischemic cardiomyopathy who underwent CABG. The ADSCs, suspended in fibrin glue, were sprayed directly onto the heart during surgery. Primary endpoints encompassed adverse events, late gadolinium-enhanced magnetic resonance imaging (LGE-MRI) volume changes, and feasibility. Secondary endpoints included alterations in left ventricular function, exercise tolerance, and heart failure symptoms. Results: All patients underwent surgery successfully without complications. ADSC spray transplantation, evidenced by a reduced LGE-MRI volume, exhibited potential therapeutic benefits by improving left ventricular function and exercise tolerance in the ADSC group compared to the placebo group (Figures 1 and 2). Adverse events were minimal and primarily associated with the CABG procedure. Conclusions: This study establishes the safety and feasibility of ADSC spray transplantation combined with CABG for the treatment of ischemic cardiomyopathy. The observed improvements in LGE-MRI volume and cardiac function suggest a potential therapeutic effect, warranting further investigation in larger phase II and III clinical trials. This novel approach holds promise as a clinically viable treatment strategy to enhance revascularization outcomes in patients with ischemic cardiomyopathy. Registration: https://clinicaltrials.gov/study/NCT04695522 https://jrct.niph.go.jp/en-latest-detail/jRCT2053190103