Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age30-90
SponsorDr Cipto Mangunkusumo General Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Presence of congenital heart disease.
Diagnosis of Down syndrome.
Diagnoses other than biliary atresia confirmed by intraoperative cholangiography (e.g., choledochal cyst)
Trial design
Design model
Parallel
Treatments tested in this trial
Umbilical Cord-Mesenchymal Stem Cells (UC-MSC)
Biological/VaccineIntraoperative 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
Kasai Portoenterostomy
Procedure/SurgeryStandard surgical resection of extrahepatic biliary remnants with a Roux-en-Y portoenterostomy to restore bile drainage in biliary atresia patients
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: UC-MSC GroupExperimental treatment 2 interventions
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total Bilirubin Level
Measurement of total bilirubin level
Time frame
Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 180Secondary outcomes
1
Direct Bilirubin Level
Measurement of direct bilirubin level
Time frame
Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 1802
Indirect Bilirubin Level
Measurement of indirect bilirubin levels
Time frame
Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 1803
AST (Aspartate Transaminase) Levels
Hepatocellular injury marker
Time frame
Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 1804
ALT(Alanine Transaminase) Levels
Hepatocellular injury marker
Time frame
Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 180Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr Cipto Mangunkusumo General Hospital
Lead sponsor
PT. Kimia Farma (Persero) Tbk
Collaborator
Source ClinicalTrials.gov