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

NCT07265349 | Recruiting Phase 1

• 1 other identifier: TASLY-BM-B2278-HF-I/Ⅱ
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• The changes in left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), and left ventricular end-systolic volume (LVESV) on CMR compared to the baseline.

  6 months

• The changes from baseline of LVEF, left ventricular end-systolic diameter (LVESD), left ventricular end-diastolic diameter (LVEDD), LVEDV, LVESV on UCG

  28 days, 3 months and 6 months

• The proportion of participants with improved LVEF (the proportion of participants whose LVEF increased by ≥10% compared to the baseline and whose LVEF was >40% based on CMR and/or UCG);

  3 months and 6 months

• The distribution of the New York Heart Association (NYHA) cardiac function classification

  28 days, 3 months and 6 months

• The proportion of participants with NYHA classification ≤ II level

  28 days, 3months and 6months

Other Outcomes (3)

• The change in troponin I (TnI) compared to the baseline

  28 days, 3 months and 6months

• The changes from the baseline of high-sensitivity C-reactive protein (hs-CRP), TNF-α, IL-1, and IL-6

  28 days, 3 months and 6 months

• The changes in perfusion and metabolism of ischemic myocardium during the injection stage as measured by myocardial nuclear imaging (SPECT + PET) compared to the baseline (applicable only to those who have undergone nuclear imaging for determination)

  6 months

Study Arms (4)

CABG combined with low-dose B2278

EXPERIMENTAL

CABG combined with B2278 at a dose of 1.0×10\^7 cells per patient, intramyocardial injection into the epicardium

Drug: Mesenchymal stem cells(HucMSCs)

CABG combined with midium-dose B2278

EXPERIMENTAL

CABG combined with B2278 at a dose of 5.0×10\^7 cells per patient, intramyocardial injection into the epicardium

Drug: Mesenchymal stem cells(HucMSCs)

CABG combined with high-dose B2278

EXPERIMENTAL

CABG combined with B2278 at a dose of 2.0×10\^8 cells per patient, intramyocardial injection into the epicardium

Drug: Mesenchymal stem cells(HucMSCs)

Only CABG

EXPERIMENTAL

Only CABG surgery

Procedure: CABG

Interventions

CABG PROCEDURE

only CABG

Only CABG

Mesenchymal stem cells(HucMSCs) DRUG

B2278 is mesenchymal stem cells derived from human umbilical cord.

CABG combined with high-dose B2278; CABG combined with low-dose B2278; CABG combined with midium-dose B2278

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Age from 18 to 80 years, both genders are eligible ;
• \) Clinically judged to be suitable for CABG treatment due to chronic ischemic cardiomyopathy;
• \) LVEF (left ventricular ejection fraction) is ≤ 40% as indicated by echocardiography (modified Simpson method) or cardiac magnetic resonance (CMR);
• \) NYHA (New York Heart Association) cardiac function classification of grade II-IV;
• \) Patients or their legal guardians agreed to participate in this trial and signed the informed consent form.

You may not qualify if:

• \) Severe left ventricular dysfunction, with LVEF ≤ 20% (based on the UCG or CMR examination results during the screening period);
• \) 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);
• \) 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；
• \) Acute ST-segment elevation myocardial infarction or stroke event within 1 month before enrollment；
• \) Uncontrolled malignant arrhythmia;
• )have undergone or are awaiting heart transplantation or implantation of a left ventricular assist device (LVAD).

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead
• Shanghai Jiao Tong University School of Medicine, Ruijin Hospital: collaborator

Study Sites (4)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 20000, China

RECRUITING

Changhai Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Central Study Contacts

Qiang Zhao

CONTACT

86+13701695256; Zq11607@rjb.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 4, 2025
• Study Start: December 26, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

CN (4)