Bone Mesenchymal Stem Cell (BMSC) Transplantation in Liver Cirrhosis Via Portal Vein

Sun Yat-sen University60 enrolled

Overview

The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via portal vein in patients with early and middle stage of liver cirrhosis on the basis of HBV infection. The evaluation of the efficacy includes the level of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Cirrhosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18\~60 years. * Serum HBsAg positive. * Ultrasonographic evidences of cirrhosis. Exclusion Criteria: * history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment. * Prothrombin time is less than 30s. * Cirrhosis caused by other reasons except HBV infection. * Severe problems in other vital organs(e.g.the heart,renal or lungs). * Liver tumor on ultrasonography, CT or MRI examination. * Pregnant or lactating women. * Imaging evidences of vascular thromboses.

Outcomes

Primary Outcomes

The levels of serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement.

Time frame: pre-transplantation, and 1week to 1 year post-transplantation