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

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.

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)

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.

Sponsors & Collaborators

• Universitas Diponegoro

  lead OTHER

Principal Investigators

• Avriana Pety Wardani, MD, Sp.BA · Dr. Kariadi General Hospital Medical Center

• Erik Prabowo, Dr, MD, M.Si.Med, Sp.B-KBD · Dr. Kariadi General Hospital Medical Center

• Kevin Christian Tjandra, MD · Universitas Diponegoro

• Danendra Rakha Putra Respati, MD · Universitas Diponegoro

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

0 Days

Max Age

90 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-17

Primary Completion

2026-04-17

Completion

2026-04-17

Countries

• Indonesia

Study Locations