Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells

October 16, 2012 updated by: Shuichi Kaneko, Kanazawa University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: adipose tissue derived stromal cells
Biological: adipose tissue derived stromal cells
dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause harmful events
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanazawa University

Investigators

  • Study Chair: Shuichi Kaneko, M.D., Kanazawa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

June 3, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

October 18, 2012

Last Update Submitted That Met QC Criteria

October 16, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 675

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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