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.
• 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.