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Safety and Efficacy of Autologous Cultured Adipocytes in Patient With Depressed Scar

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: NCT00992147
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : October 9, 2009
Information provided by:
Anterogen Co., Ltd.

Brief Summary:
Autologous cultured adipocytes (ANTG-adip) is produced by well-established techniques including cell harvesting from lipoaspirates, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label, dose-escalation study. Patients are given subcutaneous injection of ANTG-adip and followed for 12 weeks according to the clinical trial protocol.

Condition or disease Intervention/treatment Phase
Depressed Scar Drug: Adipocell Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II/III Clinical Study of ANTG-adip for the Treatment of Depressed Scar to Evaluate Safety and Efficacy
Study Start Date : May 2004
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: autologous cultured adipocytes Drug: Adipocell
autologous cultured adipocytes (ANTG-adip)

Primary Outcome Measures :
  1. Efficacy: recovery rate(%) [ Time Frame: week 12 ]
  2. Safety: clinically measured abnormality of laboratory tests and adverse events, Injection site observation, Immune rejection test

Secondary Outcome Measures :
  1. Recovery rate (%) [ Time Frame: day 7, 14, 21, 28 days and week 8 ]
  2. A digital photograph [ Time Frame: day 1, 3, 7, 14, 21, 28, week 8 and week 12 ]
  3. Patient satisfaction [ Time Frame: week 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • older than 19 years
  • depressed scar less than volume of 5 ml
  • negative for urine beta-HCG for women of childbearing age
  • agreement to participate, with signed informed-consent

Exclusion Criteria:

  • failure to meet inclusion criteria
  • any immune-suppressive drug, corticosteroid or cytotoxic drug within the previous 30 days
  • allergy to bovine-derived materials
  • Diagnosis of cancer, AIDS, HBV or HCV.
  • Patient has a lot of hairs or a tattoo on depressed site
  • Insufficient adipose tissue for manufacturing of ANTG-adip
  • Patient has depressed scar caused by a malignant tumor
  • Patient whom investigator consider is not suitable in this study

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): NCT00992147

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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: Gab-sung Oh, M.D Samsung Medical Center
Layout table for additonal information Identifier: NCT00992147    
Other Study ID Numbers: ANTG-adip-301
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: October 9, 2009
Last Verified: October 2009
Additional relevant MeSH terms:
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Consciousness Disorders
Behavioral Symptoms
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders