RecruitingPhase 1Phase 2NCT07265349

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

A Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Intramyocardial Injection of Human Umbilical Cord Mesenchymal Stem Cells (HucMSCs) Combined With Coronary Artery Bypass Grafting in the Treatment of Chronic Heart Failure Caused by Chronic Ischemic Cardiomyopathy

Sponsor

Tasly Pharmaceutical Group Co., Ltd

Enrollment

51 participants

Start Date

Dec 26, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Heart Failure Coronary Artery Bypass Grafting (CABG)Chronic Ischemic Cardiomyopathy

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial is testing whether injecting a type of stem cell (called umbilical cord mesenchymal stem cells, or HucMSCs) directly into the heart muscle during bypass surgery can help improve heart function in people with chronic heart failure caused by reduced blood supply to the heart. **You may be eligible if...** - You are between 18 and 80 years old - You are scheduled for coronary artery bypass graft (CABG) surgery due to chronic ischemic heart disease - Your heart pumps at 40% or less of its normal capacity (low ejection fraction) - You have moderate to severe heart failure symptoms (NYHA class II–IV) **You may NOT be eligible if...** - Your heart function is extremely poor (ejection fraction 20% or below) - Your heart failure is not caused by blocked arteries (e.g., dilated cardiomyopathy) - You need additional procedures during bypass surgery (e.g., valve repair, aneurysm repair) - You had a heart attack or stroke in the past month - You have uncontrolled dangerous heart rhythms - You have previously had or are waiting for a heart transplant or ventricular assist device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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