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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
14
Intraoperative trans-portal vein injection of 20 million mesenchymal stem cells derived from umbilical cord tissue, suspended in 5 mL autologous plasma.
Surgical procedure to create a portoenterostomy for biliary drainage in infants with biliary atresia.
Dr. Kariadi General Hospital Medical Center
Semarang, Central Java, Indonesia
Serum Albumin Level
Measurement of serum albumin as marker of liver synthetic function
Time frame: Baseline (Pre-op), 4 weeks, 6 weeks, 12 weeks, 24 weeks, and 12 months post-operation
Total Bilirubin Level
Measurement of bilirubin levels (total, direct, indirect)
Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Gamma Glutamyl Transferase (GGT)
Measurement of liver enzyme levels
Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Alanine Aminotransferase (ALT)
Liver injury marker
Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Aspartate Aminotransferase (AST)
Liver injury marker
Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Prothrombin Time (PT), aPTT, INR
Coagulation parameters
Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Alpha Fetoprotein (AFP)
Tumor marker
Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Alkaline Phosphatase (ALP)
Liver and bone function marker
Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Lactate Dehydrogenase (LDH)
Tissue injury marker
Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Anemia Status
Clinical and laboratory evaluation of anemia
Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Ascites
Clinical evaluation via physical exam and ultrasound
Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Jaundice Status
Clinical and laboratory bilirubin assessment
Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Pediatric End-Stage Liver Disease (PELD) Score
Disease severity scoring system
Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Overall Survival (OS)
Survival rate since intervention
Time frame: From the surgery date up to the end of the study (12 months maximum follow-up)
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