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Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00913289
First Posted: June 4, 2009
Last Update Posted: October 18, 2012
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.
Information provided by (Responsible Party):
Shuichi Kaneko, Kanazawa University
  Purpose
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 Intervention Phase
Liver Cirrhosis Biological: adipose tissue derived stromal cells Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells

Resource links provided by NLM:


Further study details as provided by Shuichi Kaneko, Kanazawa University:

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

Enrollment: 6
Study Start Date: February 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
adipose tissue derived stromal cells Biological: adipose tissue derived stromal cells
dosage

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.
  Eligibility

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
  Contacts and Locations
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
  More Information

Responsible Party: Shuichi Kaneko, Professor, Kanazawa University
ClinicalTrials.gov Identifier: NCT00913289     History of Changes
Other Study ID Numbers: 675
First Submitted: June 3, 2009
First Posted: June 4, 2009
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