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Safety of Repaircell in Healthy Volunteers

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. Identifier: NCT01739530
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : December 4, 2012
Information provided by (Responsible Party):
Anterogen Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Biological: Repaircell Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study to Evaluate Safety of Repaircell in Healthy Volunteers
Study Start Date : March 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: Repaircell
allogenic differentiated adipocyte
Biological: Repaircell
allogenic differentiated adipocyte

Primary Outcome Measures :
  1. Number of Adverse events [ Time Frame: week 8 ]
    Evaluate the safety at week 8 whether any kind of Adverse event occurs

Secondary Outcome Measures :
  1. Immunological response II [ Time Frame: week 8 ]
    Infiltration of immune cells by histology based on five basic parameters: (0) No evidence of immune cell infiltration in all area of the tissue, (1) Slight immune cell infiltration visible in partial area of the tissue (barely visible), (2) Obvious immune cell infiltration visible in partial area of the tissue, (3) Slight immune cell infiltration visible in all area of the tissue, and (4) Intense immune cell infiltration visible in all areas of the tissue.

  2. Immunological response I [ Time Frame: change from baseline CD4/CD8 ratio at week 8 ]
    CD4 (cluster of differentiation 4)/CD8 (cluster of differentiation 8) ratio

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01739530

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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Anterogen Co., Ltd.
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Principal Investigator: Sa-ik Bang, MD Samsung Medical Center

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Responsible Party: Anterogen Co., Ltd. Identifier: NCT01739530     History of Changes
Other Study ID Numbers: ANT-adip-AL-001
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: December 2012