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NCT01062750 Clinical Trial

Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells

Liver Cirrhosis Clinical Trial

Official title:
Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01062750
Other study ID # 1132
Secondary ID
Status Completed
Phase N/A
First received February 3, 2010
Last updated September 4, 2015
Start date October 2012
Est. completion date May 2015

Study information
Verified date September 2015
Source Kanazawa University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

Mesenchymal stem cells have capability to differentiate into hepatocyte and will be useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cell compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive autologous adipose tissue derived stromal cells through intrahepatic arterial catheterization.

Description:

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 donor 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 undergo intrahepatic arterial administration of autologous adipose tissue derived stromal cells through catheter.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date May 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Criteria defined in the implementation protocol

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• adipose tissue derived stromal cells dosage
single administration of autologous adipose tissue derived stroma cells via intrahepatic arterial catheterization

Locations
Country Name City State
Japan Kanazawa University Hospital Kanazawa Ishikawa

Sponsors (1)
Lead Sponsor Collaborator
Kanazawa University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary all cause harmful events one month Yes
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