Status:
COMPLETED
Autologous Bone Marrow Mononuclear Stem Cell for Children Suffering From Liver Cirrhosis Due to Biliary Atresia
Lead Sponsor:
Vinmec Research Institute of Stem Cell and Gene Technology
Conditions:
Liver Cirrhosis, Biliary
Eligibility:
All Genders
1-15 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03468699
Start Date
January 2 2017
End Date
October 31 2021
Last Update
June 4 2024
Active Locations (2)
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1
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam, 100000
2
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam, 10000