Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by Hepatitis B Virus (HBV)

Study Overview
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Brief Summary
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Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients with Liver Failure Caused by hepatitis B virus (HBV)

Official Title
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Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by HBV

Conditions
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Liver Failure

Intervention / Treatment
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* Other: Group 1
* Other: Group 2
* Other: Group 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver failure caused by HBV Model for End-Stage Liver Disease (MELD) < 30 Exclusion Criteria: Liver Failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on. History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment. Severe problems in other vital organs (e.g.the heart,renal or lungs). Tumor on ultrasonography, CT or MRI examination. Pregnant or lactating women. HIV infection.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Thirty of the enrolled patients were assigned to Group A to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine. | Other: Group 1<br>* Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(2×105/Kg, once a week, 4 times).<br>Other: Group 2<br>* Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(1×106/Kg, once a week, 4 times).<br>Other: Group 3<br>* Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(5×106/Kg, once a week, 4 times).<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), aspartate aminotransferase(AST),total bilirubin (TB),prothrombin time (PT), prothrombin activity(PTA),INR,albumin (ALB),globulin(GLB), prealbumin(PA),creatinine(Cr), Urea nitrogen(BUN),number of leucocyte,erythrocyte and platelet, cytokines,liver histological | 12months | 
| Immune state | cytokine | 12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABMLF, Allogenic Bone marrow Mesenchymal Stem Cells, Liver Failure, Transplantation