NCT07797673 Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia
| NCT ID | NCT07797673 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Dr Cipto Mangunkusumo General Hospital |
| Condition | Biliary Atresia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2026-09-01 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Radiana Dhewayani Antarianto, MD, M.Biomed, PhD
PRINCIPAL INVESTIGATOR
University of Indonesia, Cipto Mangunkusumo Hospital
Frequently Asked Questions
Who can join the NCT07797673 clinical trial?
This trial is open to participants of all sexes, aged 30 Days or older, up to 90 Days, studying Biliary Atresia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07797673 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07797673 currently recruiting?
Yes, NCT07797673 is actively recruiting participants. Contact the research team at rahayatri@gmail.com for enrollment information.
Where is the NCT07797673 trial being conducted?
This trial is being conducted at Jakarta Pusat, Indonesia.
Who is sponsoring the NCT07797673 clinical trial?
NCT07797673 is sponsored by Dr Cipto Mangunkusumo General Hospital. The principal investigator is Radiana Dhewayani Antarianto, MD, M.Biomed, PhD at University of Indonesia, Cipto Mangunkusumo Hospital. The trial plans to enroll 40 participants.