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RECRUITING
NCT06564740
NA

Stem Cell Applications in Biliary Atresia Patients

Sponsor: Necmi Kadıoğlu Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Months - 18 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2024-06-01

Completion Date

2026-06-01

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

DRUG

Stem 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.

OTHER

Control

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.

Locations (1)

Esenyurt State Hospital

Istanbul, Istanbul, Turkey (Türkiye)