Back to resultsLiver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells
Primary Purpose
Liver Cirrhosis
Status
Terminated
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
adipose tissue derived stromal cells
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis focused on measuring Liver Cirrhosis
Eligibility Criteria
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
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
1. Study Identification
Unique Protocol Identification Number
NCT00913289
Brief Title
Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells
Official Title
Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanazawa University
4. Oversight
5. Study Description
Brief Summary
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
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.
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
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (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
Intervention Description
dosage
Primary Outcome Measure Information:
Title
all cause harmful events
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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 Using Autologous Adipose Tissue Derived Stromal Cells
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