NCT06564740 Stem Cell Applications in Biliary Atresia Patients
| NCT ID | NCT06564740 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Necmi Kadıoğlu Hospital |
| Condition | Biliary Atresia |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2024-06-01 with a primary completion date of 2026-05-30.
⚠ 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
Recently, mesenchymal stem cell (MSC) transplantation has emerged as a promising treatment for liver cirrhosis in adults. Additionally, bone marrow-derived stem cell transplantation has shown success in treating children with biliary atresia (BA). This study aims to evaluate the efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell (UC-MSC) therapy in BA through a multicentric randomized controlled trial.
Eligibility Criteria
Inclusion Criteria: * Infants were diagnosed with liver cirrhosis due to biliary atresia following Kasai's operation. * The patients two months old or older and exhibited signs of cirrhosis after the procedure, including hepatomegaly, congestive splenomegaly, elevated liver enzymes, esophageal varices (confirmed by endoscopy), and cirrhosis (confirmed by liver biopsy). Exclusion Criteria: * Epilepsy * Neurological disorders * Coagulation disorders * Diabetes * Syndromic type biliary atresia * Allergies to anesthetic agents * Severe health conditions such as cancer or failure of the heart, lungs, liver, or kidneys, active infections, and severe psychiatric disorders.
Contact & Investigator
Mustafa Azizoglu, MD, PhD
PRINCIPAL INVESTIGATOR
Esenyurt State Hospital
Frequently Asked Questions
Who can join the NCT06564740 clinical trial?
This trial is open to participants of all sexes, aged 2 Months or older, up to 18 Years, 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.
Is NCT06564740 currently recruiting?
Yes, NCT06564740 is actively recruiting participants. Contact the research team at mdmazizoglu@gmail.com for enrollment information.
Where is the NCT06564740 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT06564740 clinical trial?
NCT06564740 is sponsored by Necmi Kadıoğlu Hospital. The principal investigator is Mustafa Azizoglu, MD, PhD at Esenyurt State Hospital. The trial plans to enroll 64 participants.