NCT07265349 A Phase I/II Clinical Trial of Intramyocardial Injection of HucMSCs for the Treatment of Chronic Heart Failure
| NCT ID | NCT07265349 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Tasly Pharmaceutical Group Co., Ltd |
| Condition | Coronary Artery Bypass Grafting (CABG) |
| Study Type | INTERVENTIONAL |
| Enrollment | 51 participants |
| Start Date | 2025-12-26 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 51 participants in total. It began in 2025-12-26 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 1\) Age from 18 to 80 years, both genders are eligible ; * 2\) Clinically judged to be suitable for CABG treatment due to chronic ischemic cardiomyopathy; * 3\) LVEF (left ventricular ejection fraction) is ≤ 40% as indicated by echocardiography (modified Simpson method) or cardiac magnetic resonance (CMR); * 4\) NYHA (New York Heart Association) cardiac function classification of grade II-IV; * 5\) Patients or their legal guardians agreed to participate in this trial and signed the informed consent form. Major exclusion Criteria: * 1\) Severe left ventricular dysfunction, with LVEF ≤ 20% (based on the UCG or CMR examination results during the screening period); * 2\) Non-ischemic chronic left heart dysfunction, including but not limited to acute left heart dysfunction, dilated cardiomyopathy, severe right heart dysfunction (such as bilateral lower extremity edema accompanied by jugular vein distension, liver enlargement, etc.) or severe pulmonary hypertension (PASP \> 70 mmHg); * 3\) Clinically determined that other surgical procedures need to be performed simultaneously during CABG surgery, including but not limited to congenital heart disease requiring concurrent surgical intervention, heart valve disease, ventricular aneurysm, ventricular septal perforation, papillary muscle dysfunction, aortic dissection, intracardiac mass, thrombus or neoplasm； * 4\) Acute ST-segment elevation myocardial infarction or stroke event within 1 month before enrollment； * 5\) Uncontrolled malignant arrhythmia; * 6)have undergone or are awaiting heart transplantation or implantation of a left ventricular assist device (LVAD).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07265349 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Coronary Artery Bypass Grafting (CABG). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07265349 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07265349 currently recruiting?
Yes, NCT07265349 is actively recruiting participants. Contact the research team at Zq11607@rjb.com.cn for enrollment information.
Where is the NCT07265349 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China, Shanghai, China, Shanghai, China.
Who is sponsoring the NCT07265349 clinical trial?
NCT07265349 is sponsored by Tasly Pharmaceutical Group Co., Ltd. The trial plans to enroll 51 participants.