Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis

Sun Yat-sen University60 enrolled

Overview

The objective of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver cirrhosis. 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

Allogenic bone marrow stem cells transplantationPROCEDURE

30ml allogenic bone marrow stem cells were infused to patients using interventional method via portal vein or hepatic artery as well as conserved therapy

Conserved therapyDRUG

Oral or intravenous administration

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 16\~65 years. * Serum HBsAg positive for over six months. * 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 over 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.

Locations (1)

Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Liver Function

Time frame: 12 months

Secondary Outcomes

Immunity

Time frame: 12 months

Data from ClinicalTrials.gov

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