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Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia

RecruitingPhase 1Ages 30 Days - 90 DaysAllDr Cipto Mangunkusumo General Hospital
NCT07797673 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 stiffn

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📋 Eligibility rules (as published)
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
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What it tests

  • Umbilical Cord-Mesenchymal Stem Cells (UC-MSC)
  • Kasai Portoenterostomy
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Where

1 site
Cipto Mangunkusumo Hospital
Jakarta Pusat, Indonesia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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