Phase III Study of Intramyocardial Injection of Human Umbilical Cord Mesenchymal Stem Cells with Coronary Artery Bypass Surgery to Treat Chronic Heart Failure from Ischemic Cardiomyopathy

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a human umbilical cord mesenchymal stem cell injection called B2278 in combination with coronary artery bypass grafting CABG surgery for treating chronic heart failure caused by chronic ischemic cardiomyopathy. This multi-center Phase III clinical trial aims to find the best dose and treatment schedule for injecting B2278 directly into the heart muscle during surgery. Preliminary studies suggest B2278 may help repair the heart by reducing inflammation, promoting blood vessel growth, and regulating immune responses. Participants will undergo CABG surgery combined with different doses of B2278 injected into the epicardium, including low, medium, and high doses, or CABG surgery alone without B2278. The trial compares these four groups to explore the safety, tolerance, and heart function effects of adding B2278 to surgery. This approach focuses on direct heart treatment during CABG to address chronic heart failure caused by ischemic damage. During the study, participants will be monitored through various heart function tests such as cardiac magnetic resonance imaging and echocardiography at scheduled intervals up to six months after treatment. Researchers will assess safety events, heart pumping efficiency, heart size, walking ability, quality of life, and heart failure symptoms. Follow-up visits will include questionnaires, imaging, and blood tests to track changes and ensure participant safety throughout the trial period.

A Phase I/II Clinical Trial of Intramyocardial Injection of HucMSCs for the Treatment of Chronic Heart Failure