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

B2278 is a human umbilical cord mesenchymal stem cell (HucMSCs) injection derived from the umbilical cord. It has the advantages of stronger immune regulation, stronger expansion capacity, lower immunogenicity, and greater accessibility. The preliminary research results indicated that the B2278 injection promote the polarization of macrophages towards a reparative state through paracrine action, directly promote angiogenesis and inhibited inflammatory responses, thereby exerting effects on myocardial repair and treatment of heart failure, and it is also safe and well-tolerated. This trial is a multi-center I/II phase clinical trial of the human umbilical cord mesenchymal stem cell injection solution, aiming to explore the dosage and regimen for the intramyocardial injection of B2278 in combination with coronary artery bypass grafting surgery for the treatment of chronic heart failure caused by chronic ischemic cardiomyopathy, and to evaluate the safety, tolerance and efficacy of allogeneic intramyocardial injection of the human umbilical cord mesenchymal stem cell injection solution in patients with chronic ischemic heart failure.

NCT Number	NCT07265349
Lead Sponsor	Tasly Pharmaceutical Group Co., Ltd Collaborators: Ruijin Hospital
Conditions	Coronary Artery Bypass Grafting (CABG), Chronic Heart Failure, Chronic Ischemic Cardiomyopathy
Enrollment	51 participants
Start Date	2025-12-26
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-09