Autologous Bone Marrow Mononuclear Stem Cell for Children Suffering From Liver Cirrhosis Due to Biliary Atresia

Vinmec Research Institute of Stem Cell and Gene Technology17 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Cirrhosis, Biliary

Interventions

Autologous BMMC transplantationCOMBINATION_PRODUCT

Stem cell transplantation

Eligibility

Sex: ALLMin age: 1 YearMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Vietnam

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Vietnam

Outcomes

Primary Outcomes

Assess the changes in cholestasis

Using Bilirubin (total, direct and indirect) (units: mg/dL) to measure the changes in cholestasis

Time frame: Baseline, 3, 6 months and 12 months after transplantation

Assess the changes in Liver function

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

Time frame: Baseline, 3, 6 months and 12 months after transplantation

Assess the changes in level of cirrhosis

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).

Time frame: Baseline, 3, 6 months and 12 months after transplantation

Assess the changes in liver biopsy

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

Time frame: Baseline, 3, 6 months and 12 months after transplantation

Data from ClinicalTrials.gov

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