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Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells

NCT ID: NCT00913289

Last Updated: 2012-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Liver Cirrhosis

Keywords

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Liver Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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adipose tissue derived stromal cells

Group Type OTHER

adipose tissue derived stromal cells

Intervention Type BIOLOGICAL

dosage

Interventions

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adipose tissue derived stromal cells

dosage

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kanazawa University

OTHER

Sponsor Role lead

Responsible Party

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Shuichi Kaneko

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuichi Kaneko, M.D.

Role: STUDY_CHAIR

Kanazawa University

Locations

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Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Site Status

Countries

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Japan

Other Identifiers

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675

Identifier Type: -

Identifier Source: org_study_id