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Completed

NCT Number: NCT03468699

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

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

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Key information

Conditions

Liver Cirrhosis, Biliary Bile Duct Diseases Biliary Atresia Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous BMMC transplantation

Combination Product

Stem cell transplantation

Primary outcomes

  1. 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

  2. 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

  3. 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).

  4. 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

Sponsors and collaborators

Lead sponsor

Vinmec Research Institute of Stem Cell and Gene Technology

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2018
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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