Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by Hepatitis B Virus (HBV)

Sun Yat-sen University120 enrolled

Overview

Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients with Liver Failure Caused by hepatitis B virus (HBV)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Liver Failure

Interventions

Group 1OTHER

Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(2×105/Kg, once a week, 4 times).

Group 2OTHER

Group 3OTHER

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Liver failure caused by HBV * Model for End-Stage Liver Disease (MELD) \< 30 Exclusion Criteria: * Liver Failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on. * History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment. * Severe problems in other vital organs (e.g.the heart,renal or lungs). * Tumor on ultrasonography, CT or MRI examination. * Pregnant or lactating women. * HIV infection.

Outcomes

Primary Outcomes

Liver Function

The levels of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST),total bilirubin (TB),prothrombin time (PT), prothrombin activity(PTA),INR,albumin (ALB),globulin(GLB), prealbumin(PA),creatinine(Cr), Urea nitrogen(BUN),number of leucocyte,erythrocyte and platelet, cytokines,liver histological

Time frame: 12months

Immune state

cytokine

Time frame: 12months

Data from ClinicalTrials.gov

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