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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
History of Changes

September 28, 2009
October 8, 2009
May 2004
Not Provided
  • Efficacy: recovery rate(%) [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
  • Safety: clinically measured abnormality of laboratory tests and adverse events, Injection site observation, Immune rejection test
Same as current
Complete list of historical versions of study NCT00992147 on ClinicalTrials.gov Archive Site
  • 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Depressed Scar
Drug: Adipocell
autologous cultured adipocytes (ANTG-adip)
Other Name: Adipocell
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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00992147
ANTG-adip-301
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