Clinical Outcomes of Early Kasai Surgery With Umbilical Cord MSCs in Biliary Atresia

Launched by UNIVERSITAS DIPONEGORO · May 30, 2025

Keywords

ClinConnect Summary

This clinical trial is looking into a new treatment option for infants with biliary atresia, a condition that affects the liver and bile ducts. The researchers want to find out if using special cells from umbilical cord tissue, called umbilical cord-derived mesenchymal stem cells (UC-MSCs), can help improve liver function and overall health in babies who undergo a surgery called Kasai portoenterostomy before they turn 90 days old. They will compare the outcomes of infants receiving this new therapy with a group of babies who had the surgery in the past without the stem cell treatment.

To be eligible for the study, infants must be diagnosed with biliary atresia and have the surgery before they are 90 days old. Their parents or guardians will need to agree to participate in the study and follow the necessary procedures. During the trial, participants will receive the surgery and then a special injection of UC-MSCs. After the procedure, the infants will be carefully monitored through regular check-ups and tests to see how well they're doing and to ensure their safety. This study is not yet recruiting participants but aims to gather important information on whether this new treatment could improve survival rates and reduce complications for these young patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Infants diagnosed with biliary atresia confirmed by intraoperative findings.
• • Underwent Kasai portoenterostomy at an age less than 90 days.
• • Parents or legal guardians have provided informed consent to participate in the study and follow all study procedures.
• Exclusion Criteria:
• • Infants with severe malnutrition.
• • Infants with major congenital anomalies other than biliary atresia.
• • Infants with positive tumor markers.