Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells

Study Overview
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Brief Summary
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Mesenchymal stem cells have the capability to differentiate into hepatocytes and will be useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cells compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive autologous adipose tissue derived stromal cells which include such mesenchymal stem cells.

Detailed Description
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The population of the liver cirrhosis patients is enormous in Japan and the only radical treatment for them is liver transplantation. However, the number of giving donors is extremely limited. Mesenchymal stem cells have been capable to differentiate into mesodermal-lineage cells as well as endodermal-lineage cells such as hepatocytes. They reside in the mesenchymal tissues such as bone marrows as well as adipose tissues. The latter tissues are relatively enriched with mesenchymal stem cells compared to bone marrow cells. In this study, the cirrhotic patients will receive autologous adipose tissue derived stromal cells which contains substantial number of mesenchymal stem cells.

Official Title
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Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Biological: adipose tissue derived stromal cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver cirrhosis patients Platelets count in peripheral blood: over 7.0x10^4/microliter Serum creatinine: less than 1.5 mg/dl Capable of understanding the features of this clinical trial Exclusion Criteria: Associated with risky gastroesophageal varices for bleeding Severe portal hypertension Complicated with severe heart failure Renal disease Respiratory disease Hematological disease Coagulation disturbance and judged to be excluded by doctors Associated with malignancy Past history of the following: malignancy ischemic heart disease cerebrovascular disease (cerebral infarction, cerebral hemorrhage) decompensated status of liver cirrhosis Pregnant, or possibility of pregnancy Infected with HIV Under mediation with adrenal corticoid steroid, anti-histamine drug Anticipated with difficulty of follow-up observation Anticipated with inconsistency of following the protocol Addiction of alcohol drinking and unable to stop drinking Other candidates who are judged to be not applicable to this study by doctors

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: adipose tissue derived stromal cells<br> | Biological: adipose tissue derived stromal cells<br>* dosage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause harmful events |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Cirrhosis