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

NCT07265349 · tracked via the Priya Life Science China tracker

Sponsor

Tasly Pharmaceutical Group Co., Ltd

Phase

Phase 1/2

Started

2025-12-26

Last updated

2026-01-09

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Mesenchymal stem cells(HucMSCs)CABG

Mesenchymal stem cells(HucMSCs): B2278 is mesenchymal stem cells derived from human umbilical cord.

CABG: only CABG

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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).

Primary outcome measure(s)

In phase I, primary outcome will be measured with safety events including DLT, AE, SAE, TEAE, and MACE. In phase II, primary outcome will be measured with the change in LVEF based on CMR detection after 6 months of administration. — 6 months

Trial sites (4)

Facility	City	Region	Status
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai Municipality	Recruiting
Changhai Hospital	Shanghai	Shanghai Municipality	Not Yet Recruiting
Shanghai Chest Hospital	Shanghai	Shanghai Municipality	Not Yet Recruiting
Shanghai General Hospital	Shanghai	Shanghai Municipality	Recruiting

More Tasly Pharmaceutical Group Co., Ltd trials in China

Efficacy and Safety of Changkang Granules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver qi Affecting the Spleen Pattern) Starting soon

A Study of the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold Recruiting

Efficacy and Safety of Xiangjurupining Capsule for Hyperplasia of Mammary Glands Recruiting

TSL2109 Capsules in Advanced Solid Tumor Patients: Safety, Tolerability, PK and Preliminary Efficacy Recruiting

Phase III Trial of Susu Zhike Granules in Children With Cold-cough Syndrome for Acute Cough Treatment Starting soon

Other trials for the same condition

Precision Subtyping and Prognostic Study of Heart Failure Based on Multi-Omics Integration and Clinical Indicators: A Prospective Single-Center Cohort Study Starting soon

Fecal Microbiota Transplantation for Elderly Patients With HFpEF: A Randomized Controlled Trial Starting soon

Vericiguat Use and Incident Atrial Fibrillation in Chronic Heart Failure Active, not recruiting

Yiqi Fumai Lyophilized Injection for Chronic Heart Failure Caused by Coronary Heart Disease Starting soon

Real-World Effectiveness and Costs of Yiqi Fumai Lyophilized Injection in Coronary Heart Disease-Related Chronic Heart Failure Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07265349 on ClinicalTrials.gov ↗ ← All trials in China