Trial | NCT00992147  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    36
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.
Study Started
May 31
2004
Study Completion
Mar 31
2007
Last Update
Oct 09
2009
Estimate

Drug Adipocell

autologous cultured adipocytes (ANTG-adip)

autologous cultured adipocytes Experimental

Criteria 

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
No Results Posted