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Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells

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.
 
ClinicalTrials.gov Identifier: NCT00913289
Recruitment Status : Terminated
First Posted : June 4, 2009
Last Update Posted : October 18, 2012
Sponsor:
Information provided by (Responsible Party):
Shuichi Kaneko, Kanazawa University

Tracking Information
First Submitted Date  ICMJE June 3, 2009
First Posted Date  ICMJE June 4, 2009
Last Update Posted Date October 18, 2012
Study Start Date  ICMJE February 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
all cause harmful events [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00913289 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells
Official Title  ICMJE Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Cirrhosis
Intervention  ICMJE Biological: adipose tissue derived stromal cells
dosage
Study Arms  ICMJE adipose tissue derived stromal cells
Intervention: Biological: adipose tissue derived stromal cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 16, 2012)
6
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2009)
9
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00913289
Other Study ID Numbers  ICMJE 675
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shuichi Kaneko, Kanazawa University
Study Sponsor  ICMJE Kanazawa University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Shuichi Kaneko, M.D. Kanazawa University
PRS Account Kanazawa University
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP