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

A Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Intramyocardial Injection of Human Umbilical Cord Mesenchymal Stem Cells (HucMSCs) Combined With Coronary Artery Bypass Grafting in the Treatment of Chronic Heart Failure Caused by Chronic Ischemic Cardiomyopathy

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Heart Failure; Chronic Ischemic Cardiomyopathy; Coronary Artery Bypass Grafting (CABG)
• Intervention / Treatment: Drug: Mesenchymal stem cells(HucMSCs); Procedure: CABG

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Qiang Zhao; Phone Number: 86+13701695256; Email: Zq11607@rjb.com.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Shanghai General Hospital
      • Contact: Fanglin Lu; Phone Number: 86+13901649602; Email: drlufanglin@yeah.net
      • Principal Investigator: Fanglin Lu
    • Shanghai, Shanghai Municipality, China, 20000
      • Recruiting
      • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Principal Investigator: Qiang Zhao
      • Contact: Qiang Zhao; Phone Number: 86+13701695256; Email: Zq11607@rjb.com.cn
    • Shanghai, Shanghai Municipality, China
      • Not yet recruiting
      • Changhai Hospital
      • Contact: Lin Han; Phone Number: 86+13601914266; Email: sh_hanlin@163.com
      • Principal Investigator: Lin Han
    • Shanghai, Shanghai Municipality, China
      • Not yet recruiting
      • Shanghai Chest Hospital
      • Principal Investigator: Dan Zhu
      • Contact: Dan Zhu; Phone Number: 86+13671573807; Email: zhudanmd@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CABG combined with low-dose B2278; 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); B2278 is mesenchymal stem cells derived from human umbilical cord.
Experimental: CABG combined with midium-dose B2278; 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); B2278 is mesenchymal stem cells derived from human umbilical cord.
Experimental: CABG combined with high-dose B2278; 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); B2278 is mesenchymal stem cells derived from human umbilical cord.
Experimental: Only CABG; Only CABG surgery	Procedure: CABG; only CABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
The changes in the 6-minute walk test (6MWT) results compared to the baseline	28 days, 3 months and 6months
The changes in the Minnesota Heart Failure Quality of Life Questionnaire (MLHFQ) from the baseline	28 days, 3months and 6months
The change in the result of amino-terminal pro-brain natriuretic peptide (NT-proBNP) compared to the baseline	28 days, 3months and 6months
The proportion of participants whose heart failure worsened (requiring hospitalization or emergency treatment due to the aggravation of heart failure symptoms and signs)	3 months and 6months

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: TASLY-BM-B2278-HF-I/Ⅱ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No