Autologous Mesenchymal Stem Cell Transplantation in Cirrhosis Patients With Refractory Ascites

Phase 3

• Conditions: Child-Pugh Score; Liver Function in Blood; Immune Function in Blood; Variation of Ascites; Characters of Quality of Life
• Interventions: Biological: autologous bone marrow mesenchymal stem cells transplantation; Biological: autologous bone marrow msenchymal stem cells transplantation

• Registration Number: NCT01854125
• Lead Sponsor: Nanjing PLA General Hospital

Brief Summary

Liver cirrhosis (LC) is the final destiny in chronic liver disease.The quality of life in liver cirrhosis patients with refractory ascites are very wretched. The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via liver artery in Child-Pugh B and C stage of liver cirrhosis patients with refractory ascites. The immunomodulatory impact of MSCs in fibrosis was confirmed, and several clinical studies have applied MSCs to eliminate the progression of fibrosis. In this research the investigators will study the affect and influence of MSCs in the patients,include assay of liver function,variation of ascites,Child-Pugh score etc.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-05
• Study Start: 2013-05
• Study First Submitted: 2013-05-12
• Study First Submitted QC: 2013-05-14
• Last Update Submitted: 2013-05-14
• Study First Posted: 2013-05-15
• Last Update Posted: 2013-05-15
• Primary Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:

Aged 18~65 years. Ultrasonographic evidences of cirrhosis. hepatic cirrhosis patients with refractory ascite.

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. 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.

Exclusion Criteria:

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
autologous bone marrow mesenchymal stem cells transplantation	autologous bone marrow msenchymal stem cells transplantation	Every patient is given 1x106 MSCs per kg infused via liver artery
stem cells transplantation	autologous bone marrow mesenchymal stem cells transplantation	autologous bone marrow mesenchymal stem cells transplantation
stem cells transplantation	autologous bone marrow msenchymal stem cells transplantation	autologous bone marrow mesenchymal stem cells transplantation
autologous bone marrow mesenchymal stem cells transplantation	autologous bone marrow mesenchymal stem cells transplantation	Every patient is given 1x106 MSCs per kg infused via liver artery
mesenchymal stem cells transplantation	autologous bone marrow mesenchymal stem cells transplantation	autologous bone marrow mesenchymal stem cells transplantation
mesenchymal stem cells transplantation	autologous bone marrow msenchymal stem cells transplantation	autologous bone marrow mesenchymal stem cells transplantation

Primary Outcome Measures

Name	Time	Method
change in immune function,liver function in blood	before and one to 12 weeks after therapy

Trial Locations

Locations (1)

Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China