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NCT Number: NCT07011199

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.

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Key information

Conditions

Biliary Atresia Bile Duct Diseases Biliary Tract Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Fibrosis Kasai Portoenterostomy Liver Cirrhosis Liver Diseases Liver Fibrosis Liver Function Disorders Mesenchymal Stem Cell Transplantation Pathologic Processes Pathological Conditions, Signs and Symptoms Survival Rate

Age range

0 day–90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dr. Kariadi General Hospital Medical Center

Semarang, Central Java, 50244, Indonesia

Location contact

Avriana Pety Wardani, MD, Sp.BA

CONTACT

[email protected]

+62 81229515791

Avriana Pety Wardani, MD, Sp.BA

PRINCIPAL_INVESTIGATOR

Danendra Rakha Putra Respati, MD

SUB_INVESTIGATOR

Erik Prabowo, Dr, MD, M.Si.Med, Sp.B-KBD

SUB_INVESTIGATOR

Kevin Christian Tjandra, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)

Biological

Intraoperative trans-portal vein injection of 20 million mesenchymal stem cells derived from umbilical cord tissue, suspended in 5 mL autologous plasma.

Kasai portoenterostomy

Procedure

Surgical procedure to create a portoenterostomy for biliary drainage in infants with biliary atresia.

Primary outcomes

  1. Serum Albumin Level

    Time frame: 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

  2. Total Bilirubin Level

    Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months

    Measurement of bilirubin levels (total, direct, indirect)

  3. Gamma Glutamyl Transferase (GGT)

    Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months

    Measurement of liver enzyme levels

  4. Alanine Aminotransferase (ALT)

    Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months

    Liver injury marker

  5. Aspartate Aminotransferase (AST)

    Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months

    Liver injury marker

  6. Prothrombin Time (PT), aPTT, INR

    Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months

    Coagulation parameters

  7. Alpha Fetoprotein (AFP)

    Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months

    Tumor marker

  8. Alkaline Phosphatase (ALP)

    Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months

    Liver and bone function marker

  9. Lactate Dehydrogenase (LDH)

    Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months

    Tissue injury marker

Secondary outcomes

  1. Anemia Status

    Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months

    Clinical and laboratory evaluation of anemia

  2. Ascites

    Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months

    Clinical evaluation via physical exam and ultrasound

  3. Jaundice Status

    Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months

    Clinical and laboratory bilirubin assessment

  4. Pediatric End-Stage Liver Disease (PELD) Score

    Time frame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months

    Disease severity scoring system

  5. Overall Survival (OS)

    Time frame: From the surgery date up to the end of the study (12 months maximum follow-up)

    Survival rate since intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Avriana Pety Wardani, MD, Sp. BA

CONTACT

[email protected]

+62 81229515791

Kevin Christian Tjandra, MD

CONTACT

[email protected]

+62 87700771775

Sponsors and collaborators

Lead sponsor

Universitas Diponegoro

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2025
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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