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.
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;
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；
Parallel
Mesenchymal stem cells(HucMSCs)
DrugB2278 is mesenchymal stem cells derived from human umbilical cord.
CABG
Procedure/Surgeryonly CABG
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.
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.
The changes from baseline of LVEF, left ventricular end-systolic diameter (LVESD), left ventricular end-diastolic diameter (LVEDD), LVEDV, LVESV on UCG
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);
The distribution of the New York Heart Association (NYHA) cardiac function classification
The change in troponin I (TnI) compared to the baseline
The changes from the baseline of high-sensitivity C-reactive protein (hs-CRP), TNF-α, IL-1, and IL-6
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)
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Tasly Pharmaceutical Group Co., Ltd
Lead sponsor
Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
Collaborator
