Clinical Outcomes of Early Kasai Surgery With Umbilical Cord MSCs in Biliary Atresia

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.

NCT Number	NCT07011199
Lead Sponsor	Universitas Diponegoro
Conditions	Biliary Atresia, Kasai Portoenterostomy, Mesenchymal Stem Cell Transplantation, Liver Function Disorders, Liver Fibrosis, Survival Rate
Enrollment	14 participants
Start Date	2025-06-17
Primary Completion	2026-04-17 (estimated)
Study Completion	2026-04-17 (estimated)
Updated on ClinicalTrials.gov	2025-06-08