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

This study has been completed.
Sponsor:
Information provided by:
Anterogen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00992147
First received: September 28, 2009
Last updated: October 8, 2009
Last verified: October 2009
September 28, 2009
October 8, 2009
May 2004
Not Provided
  • Efficacy: recovery rate(%) [ Time Frame: week 12 ]
  • Safety: clinically measured abnormality of laboratory tests and adverse events, Injection site observation, Immune rejection test
Same as current
No Changes Posted
  • Recovery rate (%) [ Time Frame: day 7, 14, 21, 28 days and week 8 ]
  • A digital photograph [ Time Frame: day 1, 3, 7, 14, 21, 28, week 8 and week 12 ]
  • Patient satisfaction [ Time Frame: week 12 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Autologous Cultured Adipocytes in Patient With Depressed Scar
A Phase II/III Clinical Study of ANTG-adip for the Treatment of Depressed Scar to Evaluate Safety and Efficacy
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.
Not Provided
Interventional
Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Depressed Scar
Drug: Adipocell
autologous cultured adipocytes (ANTG-adip)
Experimental: autologous cultured adipocytes
Intervention: Drug: Adipocell
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
March 2007
Not Provided

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00992147
ANTG-adip-301
Not Provided
Not Provided
Not Provided
Not Provided
Anterogen Co., Ltd.
Not Provided
Principal Investigator: Gab-sung Oh, M.D Samsung Medical Center
Anterogen Co., Ltd.
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP