CompletedPhase 2

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

Vietnam17 participantsStarted 2017-01-02

Plain-language 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

Who can participate

Age range1 Year – 15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Assess the changes in cholestasis

Timeframe: Baseline, 3, 6 months and 12 months after transplantation

Assess the changes in Liver function

Timeframe: Baseline, 3, 6 months and 12 months after transplantation

Assess the changes in level of cirrhosis

Timeframe: Baseline, 3, 6 months and 12 months after transplantation

Assess the changes in liver biopsy

Timeframe: Baseline, 3, 6 months and 12 months after transplantation

Trial details

NCT IDNCT03468699

SponsorVinmec Research Institute of Stem Cell and Gene Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-30

View on ClinicalTrials.gov More Liver Cirrhosis, Biliary trials