Safety and Efficacy of Human Autologous Peripheral Blood 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. In preclinical studies the investigators have demonstrated that G-CSF mobilized PBSC from patients with HBV related liver cirrhosis could differentiate into functional hepatocyte and autologous PBSC transplantation can significantly improve liver synthetic function. But further studied was needed to confirm the safety and efficacy of PBSC transplantation. In this study, a prospective, randomized, parallel clinical study was designed. The patients with HBV-related liver cirrhosis will undergo administration of human autologous PBSCs via hepatic artery to evaluate the safety and efficacy of human autologous PBSCs treatment for these patients.

Official Title
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Safety and Efficacy of Human Autologous Peripheral Blood 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: PBSC transplantation
* Other: conventional 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.the heart,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<br>conventional treatment & antiviral treatment | Other: conventional treatment<br>* Participants will receive conventional treatment and antiviral treatment.<br>|
| Experimental: conventional & PBSC transplantation<br>After three days G-CSF mobilization, Patients randomized to the intervention arm will receive autologous PBSCs transplantation at day1, and receive conventional treatment and antiviral treatment through the one year study visit and followed until one years study visit. | Other: PBSC transplantation<br>* PBSCs were mobilized with recombinant human G-CSF at 5-10ug/kg/d for three days. then PBSCs were collected by means of apheresis. The collected PBSCs were infused into participant 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, 9months and 1year after treatment | 
| Child Pugh Score |  | 1week, 4weeks,3months, 6months, 9months and 1year after treatment | 
| alpha fetoprotein |  | 1week, 4weeks,3months, 6months, 9months and 1year after treatment | 
| renal function |  | 1week, 4weeks,3months, 6months, 9months 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, stem cell, peripheral blood, autologous, HBV, end stage liver disease