Autologous Mesenchymal Stem Cell Transplantation in Cirrhosis Patients With Refractory Ascites

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Autologous Mesenchymal Stem Cell Transplantation Via Liver Artery in Liver Cirrhosis Patients With Refractory Ascites

Conditions
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Immune Function in Blood, Liver Function in Blood, Variation of Ascites, Characters of Quality of Life, Child-Pugh Score

Intervention / Treatment
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* Biological: autologous bone marrow mesenchymal stem cells transplantation
* Biological: autologous bone marrow msenchymal stem cells transplantation


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: autologous bone marrow mesenchymal stem cells transplantation<br>Every patient is given 1x106 MSCs per kg infused via liver artery | Biological: autologous bone marrow mesenchymal stem cells transplantation<br>* Autologous MSCs were infused to patients using interventional method via hepatic artery . The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes.<br>Biological: autologous bone marrow msenchymal stem cells transplantation<br> <br> |
| Active Comparator: mesenchymal stem cells transplantation<br>autologous bone marrow mesenchymal stem cells transplantation | Biological: autologous bone marrow mesenchymal stem cells transplantation<br>* Autologous MSCs were infused to patients using interventional method via hepatic artery . The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes.<br>Biological: autologous bone marrow msenchymal stem cells transplantation<br> <br> |
| Experimental: stem cells transplantation<br>autologous bone marrow mesenchymal stem cells transplantation | Biological: autologous bone marrow mesenchymal stem cells transplantation<br>* Autologous MSCs were infused to patients using interventional method via hepatic artery . The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes.<br>Biological: autologous bone marrow msenchymal stem cells transplantation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in immune function,liver function in blood |  | before and one to 12 weeks after therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immun function, liver function, ascites, quality of life, Child-Pugh score