Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia

Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia: A Double-blind Randomized Controlled Trial

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.

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