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Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells

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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

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Biological: adipose tissue derived stromal cells Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells
Study Start Date : February 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Arm Intervention/treatment
adipose tissue derived stromal cells Biological: adipose tissue derived stromal cells
dosage



Primary Outcome Measures :
  1. all cause harmful events [ Time Frame: 6 months ]


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

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

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): NCT00913289


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

Responsible Party: Shuichi Kaneko, Professor, Kanazawa University
ClinicalTrials.gov Identifier: NCT00913289     History of Changes
Other Study ID Numbers: 675
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: October 18, 2012
Last Verified: October 2012

Keywords provided by Shuichi Kaneko, Kanazawa University:
Liver Cirrhosis

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