Stem Cell Applications in Biliary Atresia Patients
Launched by NECMI KADIOĞLU HOSPITAL · Aug 19, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of a special type of stem cell therapy, called Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSC), to see if it can help infants with biliary atresia who have developed liver cirrhosis after a surgery known as Kasai's operation. Biliary atresia is a condition that affects the bile ducts in the liver, and it can lead to serious liver problems. The trial will involve multiple centers and aims to find out if this new treatment can improve liver health in these young patients.
To be eligible for this study, infants need to be at least two months old and have been diagnosed with liver cirrhosis due to biliary atresia after their surgery. They should show specific signs of liver problems, such as an enlarged liver and elevated liver enzymes. However, there are some health conditions that would prevent participation, like certain neurological disorders or severe illnesses. If a child qualifies and joins the trial, they will receive the stem cell therapy and be monitored closely to see how it affects their liver condition. This trial is currently seeking participants, and parents or guardians can get more information if they think their child may benefit from this innovative treatment.
Gender
ALL
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.
About Necmi Kadıoğlu Hospital
Necmi Kadıoğlu Hospital is a leading healthcare institution dedicated to advancing medical research and patient care through rigorous clinical trials. With a commitment to innovation and excellence, the hospital integrates state-of-the-art facilities and a multidisciplinary team of experienced professionals to conduct comprehensive studies across various therapeutic areas. By prioritizing patient safety and ethical standards, Necmi Kadıoğlu Hospital aims to contribute valuable insights to the medical community and improve treatment outcomes for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Istanbul, , Turkey
Patients applied
Trial Officials
Mustafa Azizoglu, MD, PhD
Principal Investigator
Esenyurt State Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported