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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anterogen Co., Ltd.

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