Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564740
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-17
Brief Title:
Stem Cell Applications in Biliary Atresia Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Umbilical Cord Derived Mesenchymal Stem Cell UC-MSC Transplantation in Infants with Biliary Atresia a Prospective Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 15000 to 119000 live births If the operation is not performed all patients will die due to complications of liver cirrhosis Recently mesenchymal stem cell MSC transplantation has been found to be a promising treatment for liver cirrhosis in adults Stem cell transplantation derived from bone marrow has also been successfully applied to children with BA The aim of this study is to demonstrate the efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell UC-MSC therapy in BA by planning a multicentric randomized controlled trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None