Actively Recruiting
A Phase III Clinical Trial to Evaluate the Safety and Efficacy of Intramyocardial Injection of Human Umbilical Cord Mesenchymal Stem Cells Combined With Coronary Artery Bypass Grafting in Chronic Ischemic Heart Failure
Led by Tasly Pharmaceutical Group Co., Ltd · Updated on 2026-01-09
51
Participants Needed
4
Research Sites
30 weeks
Total Duration
On this page
Sponsors
T
Tasly Pharmaceutical Group Co., Ltd
Lead Sponsor
S
Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
A Phase I/II Clinical Trial of Intramyocardial Injection of HucMSCs for the Treatment of Chronic Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 80 years, both genders are eligible
- Suitable for coronary artery bypass grafting (CABG) surgery due to chronic ischemic cardiomyopathy
- Left ventricular ejection fraction (LVEF) of 40% or less by echocardiography or cardiac magnetic resonance imaging
- New York Heart Association (NYHA) cardiac function classification grade II to IV
- Provided informed consent to participate in the trial
You will not qualify if you...
- Severe left ventricular dysfunction with LVEF of 20% or less
- Non-ischemic chronic left heart dysfunction, including acute left heart dysfunction, dilated cardiomyopathy, severe right heart dysfunction, or severe pulmonary hypertension (PASP > 70 mmHg)
- Need for additional surgical procedures during CABG, such as congenital heart disease repair, heart valve disease, ventricular aneurysm, ventricular septal perforation, papillary muscle dysfunction, aortic dissection, intracardiac mass, thrombus, or neoplasm
- Acute ST-segment elevation myocardial infarction or stroke within 1 month before enrollment
- Uncontrolled malignant arrhythmia
- History of or awaiting heart transplantation or left ventricular assist device (LVAD) implantation
Research Team
Q
Qiang Zhao
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here