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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Shuichi Kaneko, Kanazawa University
ClinicalTrials.gov Identifier:
NCT01062750
First received: February 3, 2010
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by Kanazawa University:

Primary Outcome Measures:
  • all cause harmful events [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4
Study Start Date: October 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Criteria defined in the implementation protocol

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Shuichi Kaneko, Professor, Kanazawa University
ClinicalTrials.gov Identifier: NCT01062750     History of Changes
Other Study ID Numbers: 1132
Study First Received: February 3, 2010
Last Updated: October 16, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kanazawa University:
Liver Cirrhosis

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

ClinicalTrials.gov processed this record on May 21, 2013