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

ConditionsBiliary AtresiaKasai PortoenterostomyMesenchymal Stem Cell TransplantationLiver Function DisordersLiver FibrosisSurvival Rate
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age0-90
SponsorUniversitas Diponegoro

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Infants with severe malnutrition.

Infants with major congenital anomalies other than biliary atresia.

Infants with positive tumor markers.

Trial design

Design model

Crossover

Treatments tested in this trial

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

    Biological/Vaccine

    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/Surgery

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

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: Intervention Group (UC-MSC Group)Experimental treatment 2 interventions
Group B: Control Group (Historical Control Group)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Serum Albumin Level

Measurement of serum albumin as marker of liver synthetic function

Time frame
Baseline (Pre-op), 4 weeks, 6 weeks, 12 weeks, 24 weeks, and 12 months post-operation
2

Total Bilirubin Level

Measurement of bilirubin levels (total, direct, indirect)

Time frame
Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
3

Gamma Glutamyl Transferase (GGT)

Measurement of liver enzyme levels

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

Alanine Aminotransferase (ALT)

Liver injury marker

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

Secondary outcomes

1

Anemia Status

Clinical and laboratory evaluation of anemia

Time frame
Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
2

Ascites

Clinical evaluation via physical exam and ultrasound

Time frame
Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
3

Jaundice Status

Clinical and laboratory bilirubin assessment

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

Pediatric End-Stage Liver Disease (PELD) Score

Disease severity scoring system

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitas Diponegoro

Lead sponsor

Dr. Kariadi General Hospital Medical Center

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: