Back to resultsLiver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells
Primary Purpose
Liver Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
adipose tissue derived stromal cells dosage
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis focused on measuring Liver Cirrhosis
Eligibility Criteria
Criteria defined in the implementation protocol
Sites / Locations
- Kanazawa University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
adipose tissue derived stromal cells
Arm Description
Outcomes
Primary Outcome Measures
all cause harmful events
Secondary Outcome Measures
Full Information
NCT ID
NCT01062750
First Posted
February 3, 2010
Last Updated
September 4, 2015
Sponsor
Kanazawa University
1. Study Identification
Unique Protocol Identification Number
NCT01062750
Brief Title
Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells
Official Title
Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanazawa University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Liver Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
adipose tissue derived stromal cells
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
adipose tissue derived stromal cells dosage
Intervention Description
single administration of autologous adipose tissue derived stroma cells via intrahepatic arterial catheterization
Primary Outcome Measure Information:
Title
all cause harmful events
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Criteria defined in the implementation protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuichi Kaneko, M.D.
Organizational Affiliation
Kanazawa University
Official's Role
Study Chair
Facility Information:
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells
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