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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation the Efficacy and Safety of Autologous Bone Marrow Mesenchymal Stem Cells (MSCs) Transplantation in Patients With Early and Middle Stage of Liver Cirrhosis

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Procedure: Autologous BMSCs transplantation
* Drug: Conserved therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A(conserved therapy )<br>Thirty of the enrolled patients were randomly assigned to Group A were received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine. | Drug: Conserved therapy<br>* Oral or intravenous administration<br>|
| Experimental: Group B (BMSC Transplantion)<br>Thirty of the enrolled patients were randomly assigned to Group B were received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine, as well as Bone Mesenchymal Stem Cells(BMSC) transplantation via portal vein. | Procedure: Autologous BMSCs transplantation<br>* 10 ml autologous BMSCs(7 8log10 cells/ml) were infused to patients using interventional method via portal vein as well as conserved therapy for group B.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | pre-transplantation, and 1week to 1 year post-transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMSC, Stem cells, Liver cirrhosis, Transplantation