Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal 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. Mesenchymal stem cells (MSCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, MSCs hold great hope for therapeutic applications. Human umbilical cord-derived MSCs (hUC-MSCs) exhibit a more beneficial immunogenic profile and greater overall immunosuppressive potential than aged bone marrow-derived MSCs. Like MSCs derived from bone marrow, hUC-MSCs can also be used to treat rat liver fibrosis and improve glucose homeostasis in rats with liver cirrhosis. In this study, the patients with HBV-related liver cirrhosis will undergo administration of hUC-MSCs via hepatic artery to evaluate the safety and efficacy of hUC-MSC treatment for these patients.

Official Title
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Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal 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: UC-MSC 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: UC-MSC transplantation<br>Participants will receive umbilical cord derived mesenchymal stem cell treatment at day 1 and conventional treatment and antiviral treatment through the one year study visit. Participants will then be followed until one years study visit | Other: UC-MSC transplantation<br>* After enrolled, Participant will receive umbilical cord MSC transplantation of 1*10E6 cells/kg via hepatic artery. Participant will then be followed until 1 years study visit<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, end stage liver disease, umbilical cord, mesenchymal stem cells, HBV