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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01062750
First Posted: February 4, 2010
Last Update Posted: September 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shuichi Kaneko, Kanazawa University
  Purpose
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.

Condition Intervention
Liver Cirrhosis Biological: adipose tissue derived stromal cells dosage

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells

Resource links provided by NLM:


Further study details as provided by Shuichi Kaneko, Kanazawa University:

Primary Outcome Measures:
  • all cause harmful events [ Time Frame: one month ]

Enrollment: 4
Study Start Date: October 2012
Study Completion Date: May 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
adipose tissue derived stromal cells Biological: adipose tissue derived stromal cells dosage
single administration of autologous adipose tissue derived stroma cells via intrahepatic arterial catheterization

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Criteria defined in the implementation protocol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062750


Locations
Japan
Kanazawa University Hospital
Kanazawa, Ishikawa, Japan, 920-8641
Sponsors and Collaborators
Kanazawa University
Investigators
Study Chair: Shuichi Kaneko, M.D. Kanazawa University
  More Information

Responsible Party: Shuichi Kaneko, Professor, Kanazawa University
ClinicalTrials.gov Identifier: NCT01062750     History of Changes
Other Study ID Numbers: 1132
First Submitted: February 3, 2010
First Posted: February 4, 2010
Last Update Posted: September 7, 2015
Last Verified: September 2015

Keywords provided by Shuichi Kaneko, Kanazawa University:
Liver Cirrhosis

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases