Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis

Study Overview
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Brief Summary
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HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related hepatitis can developed into liver cirrhosis. Liver transplantation is the only available life saving treatment for patients with end stage liver disease. However, lack of donors, surgical complications, rejection, and high cost are serious problems. stem cells(SCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, SCs hold great hope for therapeutic applications. Adult bone marrow is the most common source of SCs for clinical applications.Previous study showed that bone marrow derived stem cells (BMSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. In this study, the patients with HBV-related liver cirrhosis will undergo administration of human autologous BMSCs via hepatic artery to evaluate the safty and efficacy of human autologous BMSCs treatment for these patients.

Official Title
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Safety and Efficacy of Human Autologous Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis

Conditions
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Liver Cirrhosis, End Stage Liver Disease

Intervention / Treatment
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* Other: BMSC transplantation
* Other: conventional treatment & antivrial treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-65 years HBV-related liver cirrhosis Child-Pugh score 9-15 Written consent Exclusion Criteria: Hepatocellular carcinoma or other malignancies Severe problems in other vital organs(e.g.theheart,renal or lungs) Pregnant or lactating women Severe bacteria infection Anticipated with difficulty of follow-up observation Other candidates who are judged to be not applicable to this study by doctors

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional treatment<br>conventional treatment & antivrial treatment. | Other: conventional treatment & antivrial treatment<br>* Participants will recieve conventional treatment and antivrial treatment.<br>|
| Experimental: BMSC transplantation<br>conventional treatment & antiviral treatment & autologous bone marrow stem cell transplantation via hepatic artery | Other: BMSC transplantation<br>* Patients randomized to the intervention arm will be collected for bone marrow stem cells and then infused with these cells via hepatic artery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one year survival rate |  | one year after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MELD score |  | 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment | 
| AFP |  | 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment | 
| renal function |  | 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment | 
| child score |  | 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver cirrhosis, end stage liver disease, HBV, autologous, stem cell, bone morrow