RecruitingNot ApplicableNCT06564740

Stem Cell Applications in Biliary Atresia Patients

Umbilical Cord Derived Mesenchymal Stem Cell (UC-MSC) Transplantation in Infants with Biliary Atresia: a Prospective Randomized Controlled Trial

Sponsor

Necmi Kadıoğlu Hospital

Enrollment

64 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Fibrosis, Liver Biliary Atresia Stem Cell

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

Min Age: 2 MonthsMax Age: 18 Years

Inclusion Criteria2

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 Criteria7

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.

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Interventions

DRUGStem Cell

UC-MSC transplantation will be administered twice to each patient in the study group via the hepatic artery: the first transplantation will be performed post-surgery at the beginning, and the second one will be performed 6 months later, with a dose of 1 million UC-MSC/kg.

OTHERControl

In this group, UC-MSC will not be administered. This group serves as a passive control. The standard treatments that are routinely provided to these patients will continue to be administered.