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Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia

NCT07797673 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-09-01

No results posted yet for this study

Summary

Biliary atresia is a progressive liver disease in infants where liver transplantation is often the only long-term option once cirrhosis develops. However, organ shortages, high costs, risks of graft rejection, and the need for lifelong immunosuppression make transplantation difficult for many families. This double-blind randomized clinical trial evaluates whether injecting umbilical cord-mesenchymal stem cells directly into the liver during Kasai portoenterostomy is safe and effective as an additional treatment. Umbilical cord stem cells have strong anti-inflammatory and anti-fibrotic properties, and they carry a low risk of immune rejection. Patients undergoing the Kasai procedure are randomly assigned to receive either direct intrahepatic stem cell injections or a placebo. Participants are followed for 180 days post-surgery to monitor safety, liver function, and changes in liver stiffness.

Conditions

  • Biliary Atresia
  • Kasai Operation
  • Liver Fibrosis
  • Stem Cell
  • Liver Function Failure

Interventions

BIOLOGICAL

Umbilical Cord-Mesenchymal Stem Cells (UC-MSC)

Intraoperative direct intraparenchymal injections of umbilical cord-mesenchymal stem cells at a dose of 10\^5 cells/kg in 0.5 mL of 0.9% normal saline, distributed across hepatic segments 3, 4, 5, and 6 in both liver lobes

PROCEDURE

Kasai Portoenterostomy

Standard surgical resection of extrahepatic biliary remnants with a Roux-en-Y portoenterostomy to restore bile drainage in biliary atresia patients

Sponsors & Collaborators

  • PT. Kimia Farma (Persero) Tbk

    collaborator INDUSTRY

  • Dr Cipto Mangunkusumo General Hospital

    lead OTHER

Principal Investigators

  • Radiana Dhewayani Antarianto, MD, M.Biomed, PhD · University of Indonesia, Cipto Mangunkusumo Hospital

  • Fatima Safira Alatas, MD, PhD · University of Indonesia, Cipto Mangunkusumo Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Days
Max Age
90 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-09-30
Completion
2028-12-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07797673 on ClinicalTrials.gov