Mesenchymal stem cells(HucMSCs)
DrugB2278 is mesenchymal stem cells derived from human umbilical cord.
NCT Number: NCT07265349
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 1 / Phase 2
Changhai Hospital, Shanghai, Shanghai Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Major exclusion Criteria:
B2278 is mesenchymal stem cells derived from human umbilical cord.
only CABG
Time frame: 6 months
Time frame: 6 months
Time frame: 28 days, 3 months and 6 months
Time frame: 3 months and 6 months
Time frame: 28 days, 3 months and 6 months
Time frame: 28 days, 3months and 6months
Time frame: 28 days, 3 months and 6months
Time frame: 28 days, 3months and 6months
Time frame: 28 days, 3months and 6months
Time frame: 3 months and 6months
Time frame: 28 days, 3 months and 6months
Time frame: 28 days, 3 months and 6 months
Time frame: 6 months
Contact information is provided by the study sponsor or research team.
Tasly Pharmaceutical Group Co., Ltd
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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