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

Vinmec Research Institute of Stem Cell and Gene Technology

Status and phase: Completed; Phase 2

Conditions: Liver Cirrhosis, Biliary

Treatments: Combination Product: Autologous BMMC transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03468699

VinmecRISCGT78

Details and patient eligibility

About

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

Full 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

Enrollment: 17 patients

Sex: All

Ages: 1 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Autologous BMMC transplantation

Experimental group

Description:

Stem cell transplantations include 2 administrations of autologous bone marrow mononuclear cells via the hepatic artery at baseline and 6 months afterward

Treatment:

Combination Product: Autologous BMMC transplantation