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Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia
Sponsor: Dr Cipto Mangunkusumo General Hospital
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.
Official title: Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia: A Double-blind Randomized Controlled Trial
Key Details
Gender
All
Age Range
30 Days - 90 Days
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-09-01
Completion Date
2028-12
Last Updated
2026-09-09
Healthy Volunteers
No
Interventions
Umbilical Cord-Mesenchymal Stem Cells (UC-MSC)
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
Standard surgical resection of extrahepatic biliary remnants with a Roux-en-Y portoenterostomy to restore bile drainage in biliary atresia patients
Locations (1)
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia