Liver Cirrhosis, Biliary
Conditions
Keywords
Autologous bone marrow Transplantation, biliary atresia, Kasai's operation, liver cirrhosis
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's operation of 20 patients at Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam from January 2017 to December 2018
Interventions
COMBINATION_PRODUCTAutologous BMMC transplantation
Stem cell transplantation
Sponsors
Vinmec Research Institute of Stem Cell and Gene Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 15 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the changes in cholestasis | Baseline, 3, 6 months and 12 months after transplantation | Using Bilirubin (total, direct and indirect) (units: mg/dL) to measure the changes in cholestasis |
| Assess the changes in Liver function | Baseline, 3, 6 months and 12 months after transplantation | Using AST (Aspart transaminase) and ALT (Alanin transaminase) (units: U/L), GGT (Gamma GT) (units: UI/L), and Bilirubin (units: mg/dL) to measure the changes in Liver function |
| Assess the changes in level of cirrhosis | Baseline, 3, 6 months and 12 months after transplantation | Using PELD score (according to the suggestion of The Liver and Intestinal Organ Transplantation Committee in 2009). PELD is calculated based on three indicators: albumin (g / dL), bilirubin (units: mg / dL) and INR (international normalized ratio). Formula: PELD = 10 \* (0.48 \* ln(Serum Bilirubin) + 1.857 \* ln(INR) - 0.687 \* ln(Albumin) + (0.436 if patient is less than 1 year old) + (0.667 if patient has growth failure)). Evaluate the result: * If PELD \<10: good results * If 10 \<PELD \<15: average results * If PELD\> 15: bad results Albumin (Unit: g / dL), bilirubin (units: mg / dL) and INR (international normalized ratio). |
| Assess the changes in liver biopsy | Baseline, 3, 6 months and 12 months after transplantation | Liver biopsy, in combination with history and physical examination data, is a powerful clinical tool for diagnosing and treating liver disease to evaluate the changes in liver biopsy |
Countries
Vietnam
Outcome results
None listed