Clinical trial
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
Name
VinmecRISCGT78
Description
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
Trial arms
Trial start
2017-01-02
Estimated PCD
2021-09-30
Trial end
2021-10-31
Status
Completed
Phase
Early phase I
Treatment
Autologous BMMC transplantation
Stem cell transplantation
Arms:
Autologous BMMC transplantation
Size
17
Primary endpoint
Assess the changes in cholestasis
Baseline, 3, 6 months and 12 months after transplantation
Assess the changes in Liver function
Baseline, 3, 6 months and 12 months after transplantation
Assess the changes in level of cirrhosis
Baseline, 3, 6 months and 12 months after transplantation
Assess the changes in liver biopsy
Baseline, 3, 6 months and 12 months after transplantation
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 17, 'type': 'ACTUAL'}}
Updated at
2024-06-04
1 organization
1 product
2 indications
Indication
CirrhosisIndication
Biliary