Using stem cells to treat biliary atresia in infants
Umbilical Cord Derived Mesenchymal Stem Cell (UC-MSC) Transplantation in Infants with Biliary Atresia: a Prospective Randomized Controlled Trial
This study is testing if a new stem cell treatment can help improve liver function and health in infants with biliary atresia who have had surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 2 Months to 18 Years |
| Sex | All |
| Sponsor | Necmi Kadıoğlu Hospital Academic / other |
| Locations | 1 site (Istanbul, Istanbul) |
| Trial ID | NCT06564740 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Umbilical Cord-Derived Mesenchymal Stem Cell (UC-MSC) therapy in infants diagnosed with biliary atresia who have undergone Kasai's operation. Biliary atresia is a serious condition leading to liver cirrhosis in neonates, and this multicentric randomized controlled trial aims to assess whether stem cell therapy can improve liver function and overall health outcomes. The study will involve infants aged two months and older who show signs of cirrhosis, with careful monitoring and control groups for comparison.
Who should consider this trial
Good fit: Ideal candidates for this study are infants diagnosed with liver cirrhosis due to biliary atresia who are at least two months old and have undergone Kasai's operation.
Not a fit: Patients with severe health conditions, neurological disorders, or syndromic types of biliary atresia may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve liver function and quality of life for infants with biliary atresia.
How similar studies have performed: Previous studies have shown success with stem cell therapies in treating liver conditions in children, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Istanbul, Istanbul
- Esenyurt State Hospital — Istanbul, Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Mustafa Azizoglu, MD, PhD — Esenyurt State Hospital
- Study coordinator: Mustafa Azizoglu, MD, PhD
- Email: mdmazizoglu@gmail.com
- Phone: +905447448244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.