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
PhasePhase 2/Phase 3
Lead SponsorAnterogen Co., Ltd.
StatusCompleted No Results Posted
Intervention/Treatmentautologous cultured adipocytes ...
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.
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