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Safety of Repaircell in Healthy Volunteers

NCT ID: NCT01739530

Last Updated: 2012-12-04

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-12-31

Brief Summary

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Allogenic differentiated adipocytes (ANT-adip-AL) is produced by well-established techniques including cell harvesting from lipoaspirates obtained from healthy donors, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label study. Subjects were received subcutaneous injection of ANT-adip-AL and followed for 8 weeks according to the clinical trial protocol.

Detailed Description

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Conditions

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Healthy

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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Repaircell

allogenic differentiated adipocyte

Group Type EXPERIMENTAL

Repaircell

Intervention Type BIOLOGICAL

allogenic differentiated adipocyte

Interventions

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Repaircell

allogenic differentiated adipocyte

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* male, 19 years of age or older
* volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening
* informed consent form signed

Exclusion Criteria

* volunteers who have participated in other clinical studies related cell therapy within 30 days before this clinical trial
* volunteers who received any immune-suppressive drug, corticosteroid or cytotoxic drug within the previous 30 days
* volunteers who have tattoo or scar which disturb assessment of study at injection site
* volunteers who have Creutzfeldt Jacobs disease or related disease or family history
* volunteers who have allergy to bovine-derived materials
* volunteers who have infectious disease such as hepatitis B virus (HBV), hepatitis C virus (HCV)and HIV
* volunteers who have a symptom of septicemia or diagnosis of active Tuberculosis
* volunteers who have a clinically relevant history of abuse of alcohol or drugs
* volunteers who are considered not suitable for the study by investigator
* volunteers who have history of surgery for malignant cancer in the past 5 years
* volunteers who have congenital or acquired immunodeficiency syndrome
* volunteers who have horrible anemia or thrombopenia
* volunteers who have chronic disease such cardiovascular,renal and respirometer disease
* volunteers who were immunosuppressed by disease (ex: chronic heart failure)
* volunteers who were immunodepressed by treatment of medication
* volunteers who is being treated with blood derivatives/who is going to get a blood derivatives
* volunteers who have abnormal rage of CD4/CD8 ratio
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Anterogen Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sa-ik Bang, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ANT-adip-AL-001

Identifier Type: -

Identifier Source: org_study_id