RecruitingPhase 1NCT07797673

Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia

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


Sponsor

Dr Cipto Mangunkusumo General Hospital

Enrollment

40 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 30 DaysMax Age: 90 Days

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Kasai Portoenterostomy and a biological treatment called Umbilical Cord-Mesenchymal Stem Cells (UC-MSC) for people with biliary atresia, kasai operation, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 30 Days to 90 Days.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALUmbilical 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

PROCEDUREKasai 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

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NCT07797673


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