Status:
COMPLETED
Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Biliary Atresia
Lead Sponsor:
Vinmec Research Institute of Stem Cell and Gene Technology
Collaborating Sponsors:
Number 2 Children's Hospital, Ho Chi Minh City
Conditions:
Primary Biliary Cirrhosis
Eligibility:
All Genders
5-2 years
Phase:
PHASE1
PHASE2
Brief Summary
Biliary atresia (BA) is the most frequent cause of chronic cholestasis in neonates, accounting for at least 50% of pediatric liver transplantation. BA incidence is estimated to range from 1:5000 to 1:...
Detailed Description
The study protocol was approved by the Vinmec International Hospital Ethics Committee, and National Ethics Committees. The stem cell products are conducted in accordance with (GMP) requirements and Go...
Eligibility Criteria
Inclusion
- Children 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 on liver biopsy during Kasai's operation.
- Parents or primary caregivers signed the informed consent form.
Exclusion
- Under 6kg or over 2 years old
- Coagulation disorders
- Allergy to anesthetic agents
- Active infections
Key Trial Info
Start Date :
August 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04522869
Start Date
August 10 2019
End Date
October 25 2021
Last Update
June 6 2024
Active Locations (2)
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1
Vinmec International Hospital Times City
Hanoi, Hanoi, Vietnam, 100000
2
Vinmec Research Institute of Stem cell and Gene Technology
Hanoi, Vietnam, 10000