A Phase I/II Clinical Trial of Intramyocardial Injection of HucMSCs for the Treatment of Chronic Heart Failure
NCT ID: NCT07265349
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
51 participants
INTERVENTIONAL
2025-12-26
2027-08-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Mesenchymal stem cells(HucMSCs)
B2278 is mesenchymal stem cells derived from human umbilical cord.
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
Mesenchymal stem cells(HucMSCs)
B2278 is mesenchymal stem cells derived from human umbilical cord.
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
Mesenchymal stem cells(HucMSCs)
B2278 is mesenchymal stem cells derived from human umbilical cord.
Only CABG
Only CABG surgery
CABG
only CABG
Interventions
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Mesenchymal stem cells(HucMSCs)
B2278 is mesenchymal stem cells derived from human umbilical cord.
CABG
only CABG
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
UNKNOWN
Tasly Pharmaceutical Group Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TASLY-BM-B2278-HF-I/Ⅱ
Identifier Type: -
Identifier Source: org_study_id
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