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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
B2278 is mesenchymal stem cells derived from human umbilical cord.
only CABG
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGChanghai Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGShanghai Chest Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGShanghai General Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGIn 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.
Time frame: 6 months
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.
Time frame: 6 months
The changes from baseline of LVEF, left ventricular end-systolic diameter (LVESD), left ventricular end-diastolic diameter (LVEDD), LVEDV, LVESV on UCG
Time frame: 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);
Time frame: 3 months and 6 months
The distribution of the New York Heart Association (NYHA) cardiac function classification
Time frame: 28 days, 3 months and 6 months
The proportion of participants with NYHA classification ≤ II level
Time frame: 28 days, 3months and 6months
The changes in the 6-minute walk test (6MWT) results compared to the baseline
Time frame: 28 days, 3 months and 6months
The changes in the Minnesota Heart Failure Quality of Life Questionnaire (MLHFQ) from the baseline
Time frame: 28 days, 3months and 6months
The change in the result of amino-terminal pro-brain natriuretic peptide (NT-proBNP) compared to the baseline
Time frame: 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)
Time frame: 3 months and 6months
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