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RECRUITING Phase 1 ClinicalTrials.gov

Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia

Sponsor: Dr Cipto Mangunkusumo General Hospital • ClinicalTrials.gov ID: NCT07797673

Registry updated: 2026-09-09
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Description

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.

Interventions

  • Umbilical Cord-Mesenchymal Stem Cells (UC-MSC) (Biological)
    Intraoperative intraparenchymal injection of umbilical cord-derived mesenchymal stem cells (UC-MSCs) at a dose of 10\^5cells/kg, administered via a 1 mL syringe containing UC-MSCs at a concentration of 10\^5 cells/0.1mL in 0.9% NaCl, distributed across hepatic segments 3, 4, 5, and 6 in both liver lobes
  • Kasai Portoenterostomy (Procedure)
    Standard surgical resection of extrahepatic biliary remnants with a Roux-en-Y portoenterostomy to restore bile drainage in biliary atresia patients

Eligibility criteria

Inclusion Criteria: * Pediatric patients aged 30 to 90 days. * Suspected biliary atresia based on clinical evaluation and diagnostic workup. * Biliary atresia diagnosis confirmed by intraoperative cholangiography. * Undergoing Kasai portoenterostomy at Cipto Mangunkusumo Hospital. * Written informed consent provided by a parent or legally authorized representative. Exclusion Criteria: * Presence of congenital heart disease. * Diagnosis of Down syndrome. * Diagnoses other than biliary atresia confirmed by intraoperative cholangiography (e.g., choledochal cyst) Drop-out Criteria: \- Subjects will be dropped from the study if they develop postoperative anastomotic leakage

Conditions

Biliary Atresia Kasai Operation Liver Fibrosis Stem Cell Liver Function Failure

Locations

  • Cipto Mangunkusumo Hospital — Jakarta Pusat, DKI Jakarta, Indonesia
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record