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Not yet recruiting NCT07011199

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

Phase I Interventional Biliary Atresia Kasai Portoenterostomy Mesenchymal Stem Cell Transplantation Liver Function Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs), Kasai Portoenterostomy.
Who it may be relevant to
Registry conditions: Biliary Atresia, Kasai Portoenterostomy, Mesenchymal Stem Cell Transplantation, Liver Function Disorders. Basic parameters: 0 Days — 90 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Clinical Outcomes in Biliary Atresia Patients Undergoing Kasai Surgery Before 90 Days of Age With Umbilical Cord-Derived Mesenchymal Stem Cell Therapy

Overview

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.

Interventions

  • Biological Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)
    Intraoperative trans-portal vein injection of 20 million mesenchymal stem cells derived from umbilical cord tissue, suspended in 5 mL autologous plasma.
  • Procedure Kasai Portoenterostomy
    Surgical procedure to create a portoenterostomy for biliary drainage in infants with biliary atresia.

Primary outcome measures

  • Serum Albumin Level [Time frame: Baseline (Pre-op), 4 weeks, 6 weeks, 12 weeks, 24 weeks, and 12 months post-operation]
  • Total Bilirubin Level [Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
  • Gamma Glutamyl Transferase (GGT) [Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
  • Alanine Aminotransferase (ALT) [Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
  • Aspartate Aminotransferase (AST) [Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
  • Prothrombin Time (PT), aPTT, INR [Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
  • Alpha Fetoprotein (AFP) [Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
  • Alkaline Phosphatase (ALP) [Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
  • Lactate Dehydrogenase (LDH) [Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
Secondary outcome measures (5)
  • Anemia Status [Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
  • Ascites [Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
  • Jaundice Status [Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
  • Pediatric End-Stage Liver Disease (PELD) Score [Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
  • Overall Survival (OS) [Time frame: From the surgery date up to the end of the study (12 months maximum follow-up)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • Dr. Kariadi General Hospital Medical Center — Semarang

Identifiers

NCT: NCT07011199 · No.16373/EC/KEPK-RSDK/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗