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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Turkey
Esenyurt State Hospital
RECRUITING
Istanbul
Contact Information
Primary
Mustafa Azizoglu, MD, PhD
mdmazizoglu@gmail.com
+905447448244
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 64
Treatments
Experimental: Stem Cell Application Group
In this group, 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. The applications will be applied after kasai portoenterostomy.
Sham_comparator: 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 Biliary Atresia patients will continue to be administered.
Related Therapeutic Areas
Sponsors
Leads: Necmi Kadıoğlu Hospital

This content was sourced from clinicaltrials.gov