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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Liver Cirrhosis, Biliary
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Assess the changes in liver biopsy
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
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
- •Coagulation disorders
- •Allergy to anesthetic agents
- •Severe health conditions such as cancer, failure of heart, lung, liver or kidney
- •Active infections
- •Severe psychiatric disorders
Outcomes
Primary Outcomes
Assess the changes in liver biopsy
Time Frame: 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
Assess the changes in cholestasis
Time Frame: 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
Time Frame: 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
Time Frame: 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).