The goal of this clinical trial with historical control is to evaluate whether umbilical cord-derived mesenchymal stem cell (UC-MSC) therapy can improve clinical outcomes in infants with biliary atresia undergoing Kasai surgery before 90 days of age. The main questions it aims to answer are: Does UC-MSC therapy improve liver function parameters (bilirubin, albumin, liver enzymes, coagulation profile)? Does UC-MSC therapy reduce complications such as anemia, ascites, jaundice, and improve PELD scores? Does UC-MSC therapy improve overall survival compared to standard Kasai surgery alone? Researchers will compare the group receiving UC-MSC in 2025-2027 with a historical control group of patients who previously underwent Kasai surgery without UC-MSC therapy. Participants will: Undergo preoperative evaluation, including laboratory and imaging tests. Receive Kasai surgery combined with intraoperative trans-portal vein injection of 20 million UC-MSCs. Be monitored postoperatively through serial laboratory tests, imaging (Fibroscan), and clinical assessments at scheduled intervals. Be followed up for potential serious adverse events and survival outcomes.
Age range
0 Days – 90 Days
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Serum Albumin Level
Timeframe: Baseline (Pre-op), 4 weeks, 6 weeks, 12 weeks, 24 weeks, and 12 months post-operation
Total Bilirubin Level
Timeframe: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Gamma Glutamyl Transferase (GGT)
Timeframe: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Alanine Aminotransferase (ALT)
Timeframe: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Aspartate Aminotransferase (AST)
Timeframe: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Prothrombin Time (PT), aPTT, INR
Timeframe: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Alpha Fetoprotein (AFP)
Timeframe: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Alkaline Phosphatase (ALP)
Timeframe: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Lactate Dehydrogenase (LDH)
Timeframe: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months