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

Tasly Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

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

Treatments: Procedure: CABG; Drug: Mesenchymal stem cells(HucMSCs)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07265349

TASLY-BM-B2278-HF-I/Ⅱ

Details and patient eligibility

About

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.

Enrollment: 51 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 4 patient groups

CABG combined with low-dose B2278

Experimental group

Description:

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

Treatment:

Drug: Mesenchymal stem cells(HucMSCs)

CABG combined with midium-dose B2278

Experimental group

Description:

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

Treatment:

Drug: Mesenchymal stem cells(HucMSCs)

CABG combined with high-dose B2278

Experimental group

Description:

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

Treatment:

Drug: Mesenchymal stem cells(HucMSCs)

Only CABG

Experimental group

Description:

Only CABG surgery

Treatment:

Procedure: CABG