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

Phase 1

Not yet recruiting

• Conditions: Biliary Atresia; Kasai Portoenterostomy; Mesenchymal Stem Cell Transplantation; Liver Function Disorders; Liver Fibrosis; Survival Rate
• Interventions: Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs); Procedure: Kasai Portoenterostomy

• Registration Number: NCT07011199
• Lead Sponsor: Universitas Diponegoro

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-30
• Study First Submitted QC: 2025-05-30
• Last Update Submitted: 2025-05-30
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Study Start: 2025-06-17
• Primary Completion: 2026-04-17
• Study Completion: 2026-04-17

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Infants diagnosed with biliary atresia confirmed by intraoperative findings.
• Underwent Kasai portoenterostomy at an age less than 90 days.
• Parents or legal guardians have provided informed consent to participate in the study and follow all study procedures.

Exclusion Criteria

• Infants with severe malnutrition.
• Infants with major congenital anomalies other than biliary atresia.
• Infants with positive tumor markers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention Group (UC-MSC Group)	Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)	Participants in this group are infants diagnosed with biliary atresia who undergo Kasai portoenterostomy before 90 days of age. During the operation, they receive intraoperative trans-portal vein injection of umbilical cord-derived mesenchymal stem cells (UC-MSCs) at a dose of 20 million cells diluted in 5 mL autologous plasma.
Intervention Group (UC-MSC Group)	Kasai Portoenterostomy	Participants in this group are infants diagnosed with biliary atresia who undergo Kasai portoenterostomy before 90 days of age. During the operation, they receive intraoperative trans-portal vein injection of umbilical cord-derived mesenchymal stem cells (UC-MSCs) at a dose of 20 million cells diluted in 5 mL autologous plasma.
Control Group (Historical Control Group)	Kasai Portoenterostomy	Participants in this group are historical patients who previously underwent Kasai portoenterostomy before 90 days of age at the same institution but did not receive UC-MSC therapy. Data for this group is collected retrospectively.

Primary Outcome Measures

Name	Time	Method
Lactate Dehydrogenase (LDH)	Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months	Tissue injury marker
Alkaline Phosphatase (ALP)	Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months	Liver and bone function marker
Prothrombin Time (PT), aPTT, INR	Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months	Coagulation parameters
Alpha Fetoprotein (AFP)	Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months	Tumor marker
Serum Albumin Level	Baseline (Pre-op), 4 weeks, 6 weeks, 12 weeks, 24 weeks, and 12 months post-operation	Measurement of serum albumin as marker of liver synthetic function
Total Bilirubin Level	Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months	Measurement of bilirubin levels (total, direct, indirect)
Gamma Glutamyl Transferase (GGT)	Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months	Measurement of liver enzyme levels
Aspartate Aminotransferase (AST)	Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months	Liver injury marker
Alanine Aminotransferase (ALT)	Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months	Liver injury marker

Secondary Outcome Measures

Name	Time	Method
Jaundice Status	Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months	Clinical and laboratory bilirubin assessment
Anemia Status	Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months	Clinical and laboratory evaluation of anemia
Ascites	Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months	Clinical evaluation via physical exam and ultrasound
Pediatric End-Stage Liver Disease (PELD) Score	Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months	Disease severity scoring system
Overall Survival (OS)	From the surgery date up to the end of the study (12 months maximum follow-up)	Survival rate since intervention

Trial Locations

Locations (1)

Dr. Kariadi General Hospital Medical Center; 🇮🇩 Semarang, Central Java, Indonesia