Actively Recruiting
Umbilical Cord Derived Mesenchymal Stem Cell Transplantation in Infants with Biliary Atresia: A Randomized Controlled Trial
Led by Necmi Kadıoğlu Hospital · Updated on 2024-09-19
64
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Biliary atresia (BA) is a serious condition causing chronic liver problems in infants and is a leading reason for pediatric liver transplants. The condition often leads to liver cirrhosis after surgery if untreated. This research evaluates how well Umbilical Cord-Derived Mesenchymal Stem Cell (UC-MSC) therapy works for infants with BA through a multicenter randomized controlled trial, building on previous successes with stem cell treatments in adults and children. In this study, infants who have had the Kasai portoenterostomy surgery will be divided into two groups. One group will receive UC-MSC therapy administered twice through the hepatic artery: once after surgery and again six months later, at a dose of 1 million UC-MSCs per kilogram of body weight. The other group will continue with the standard BA treatments without receiving stem cells, serving as a control. Participants will be followed for two years with regular health evaluations including blood tests to measure liver enzymes and bilirubin levels, liver biopsies to assess cirrhosis, and monitoring for complications such as cholangitis. Researchers will track adverse events and other outcomes like the Pediatric End-Stage Liver Disease score, re-operation rates, and liver transplantation. This long-term follow-up aims to assess the safety and effects of UC-MSC therapy in these infants.
CONDITIONS
Brief Title
Stem Cell Applications in Biliary Atresia Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants diagnosed with liver cirrhosis due to biliary atresia following Kasai's operation
- Patients aged 2 months or older up to 18 years
- Signs of cirrhosis after Kasai's operation, including hepatomegaly, congestive splenomegaly, elevated liver enzymes, esophageal varices confirmed by endoscopy, and cirrhosis confirmed by liver biopsy
You will not qualify if you...
- 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
- Severe psychiatric disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants will be evaluated to confirm diagnosis of biliary atresia and assess liver cirrhosis status following Kasai's operation.
Duration - Day of surgery
Participants undergo Kasai portoenterostomy surgery to manage biliary atresia.
1 in-person surgical visit
Duration - 6 months between transplantations with ongoing treatment during this period
Participants in the experimental group receive two UC-MSC transplantations via the hepatic artery: the first immediately post-surgery and the second 6 months later. Participants in the control group continue with standard treatments without stem cell transplantation.
2 transplantation visits plus ongoing monitoring visits as part of routine care
Duration - Up to 2 years
Participants are monitored for adverse events and liver function for up to 2 years after treatment to assess safety and efficacy of the stem cell therapy.
Regular follow-up visits over 2 years to monitor liver health and complications
Trial Site Locations
Total: 1 location
1
Esenyurt State Hospital
Istanbul, Istanbul, Turkey (Türkiye), 34340
Actively Recruiting
Research Team
M
Mustafa Azizoglu, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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