Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver failure caused by hepatitis B 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), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores, MELD scores and clinical symptoms were also observed simultaneously.

Official Title
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Efficacy of Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Failure Resulting From Chronic Hepatitis B

Conditions
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Liver Failure

Intervention / Treatment
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* Procedure: Allogenic bone marrow stem cells transplantation
* Drug: Conserved therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 16 65 years. Serum HBsAg positive for over six months. Meet the diagnostic criteria of liver failure: 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.

Ages Eligible for Study
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Minimum Age: 16 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: 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 assigned to Group A to receive 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 assigned to Group B to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine, as well as bone marrow stem cells transplantation | Procedure: Allogenic bone marrow stem cells transplantation<br>* 30ml allogenic bone marrow stem cells were infused to patients using interventional method via portal vein or hepatic artery as well as conserved therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Function | The levels of serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), number of leucocyte,erythrocyte and platelet, cytokines, T lymphocyte and B lymphocyte,liver histological | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune function |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABMSC, Allogenic bone marrow mesenchymal stem cells, Liver Failure, Transplantation