Actively Recruiting
A Phase I/II Clinical Trial of Intramyocardial Injection of HucMSCs for the Treatment of Chronic Heart Failure
Led by Tasly Pharmaceutical Group Co., Ltd · Updated on 2026-01-09
51
Participants Needed
4
Research Sites
83 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
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.
CONDITIONS
Official 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
- Clinically suitable for coronary artery bypass grafting (CABG) due to chronic ischemic cardiomyopathy
- Left ventricular ejection fraction (LVEF) of 40% or less measured by echocardiography or cardiac magnetic resonance
- New York Heart Association (NYHA) cardiac function classification of grade II to IV
- Signed informed consent by patient or legal guardian
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 over 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, or intracardiac mass/thrombus/neoplasm
- Acute ST-segment elevation myocardial infarction or stroke within 1 month before enrollment
- Uncontrolled malignant arrhythmia
- Previous or planned heart transplantation or left ventricular assist device (LVAD) implantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 20000
Actively Recruiting
2
Changhai Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
3
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
4
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Q
Qiang Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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