Umbilical cord stem cells added during Kasai to help biliary atresia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, double-blind randomized trial investigates the safety and potential effectiveness of direct intrahepatic injections of umbilical cord mesenchymal stem cells administered during Kasai portoenterostomy in infants with suspected or confirmed biliary atresia. Participants are randomly assigned to receive either UC-MSC injections or a placebo, with follow-up for 180 days to monitor safety, liver function, and changes in liver stiffness. The study builds on the anti-inflammatory and anti-fibrotic properties of UC-MSCs to see if this adjunctive therapy can improve outcomes after the Kasai procedure. Eligible infants are enrolled at a single center in Jakarta, Indonesia, with parental consent required.

Why it matters

Who can join: the full rules

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

Where it's running

• Cipto Mangunkusumo Hospital
  Jakarta Pusat, DKI Jakarta, Indonesia Recruiting

Study contacts

• Principal investigator: Radiana Dhewayani Antarianto, MD, M.Biomed, PhD — University of Indonesia, Cipto Mangunkusumo Hospital
• Study coordinator: Tri Hening Rahayatri, MD, PhD
• Email: rahayatri@gmail.com
• Phone: +62 816 1381 223

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.