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COMPLETEDPHASE2

Autologous Bone Marrow Mononuclear Stem Cell for Children Suffering From Liver Cirrhosis Due to Biliary Atresia

Outcomes of Autologous Bone Marrow Mononuclear Stem Cell (BMMC) Transplantation for Children Suffering From Liver Cirrhosis Due to Biliary Atresia After Kasai's Operation: An Open Label Uncontrolled Clinical Trial

NCT03468699•Vinmec Research Institute of Stem Cell and Gene Technology

View on ClinicalTrials.gov

Summary

The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cell transplantation for Children Suffering from Liver Cirrhosis Due to Biliary Atresia

Detailed Description

This study is ferformed to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cell transplantation in the management of Liver Cirrhosis Due to Biliary Atresia after Kasai's operation of 20 patients at Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam from January 2017 to December 2018

Eligibility

Age

1 - 15 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Children were diagnosed with Liver Cirrhosis Due to biliary atresia after Kasai's operation
•From 5 months to 2 years old
•Weight ≥ 6 kg
•Patients with manifestation of cirrhosis after Kasai's operation: hepatomegaly, congestive splenomegaly, elevated liver enzymes, Esophageal Varices (based on Endoscopic Diagnosis), cirrhosis (based on liver biopsy)

Exclusion Criteria

•Under 1 year old patients
•Epilepsy
•Coagulation disorders
•Allergy to anesthetic agents
•Severe health conditions such as cancer, failure of heart, lung, liver or kidney
•Active infections
•Severe psychiatric disorders

Locations (2)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Vietnam

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Vietnam

Key Dates

Start Date

January 2, 2017

Primary Completion Date

September 30, 2021

Completion Date

October 31, 2021

Last Updated

June 4, 2024

Enrollment

ACTUAL participants

Conditions

Liver Cirrhosis, Biliary

Interventions

Autologous BMMC transplantation

COMBINATION_PRODUCT

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COMPLETEDNA

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UNKNOWN

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.