Status:

RECRUITING

Stem Cell Applications in Biliary Atresia Patients

Lead Sponsor:

Necmi Kadıoğlu Hospital

Conditions:

Biliary Atresia

Fibrosis, Liver

Eligibility:

All Genders

2-18 years

Phase:

NA

Brief 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 ...

Detailed Description

Biliary atresia (BA) is the most common cause of chronic cholestasis in neonates and accounts for at least 50% of pediatric liver transplants. The incidence of BA is estimated to range from 1:5000 to ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2026

Estimated Enrollment :

64 Patients enrolled

Trial Details

Trial ID

NCT06564740

Start Date

June 1 2024

End Date

June 1 2026

Last Update

September 19 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Esenyurt State Hospital

Istanbul, Istanbul, Turkey (Türkiye), 34340