Safety and Efficacy of Autologous Cultured Adipocytes in Patient With Depressed Scar
- Registration Number
- NCT00992147
- Lead Sponsor
- Anterogen Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description autologous cultured adipocytes Adipocell -
- Primary Outcome Measures
Name Time Method Efficacy: recovery rate(%) week 12 Safety: clinically measured abnormality of laboratory tests and adverse events, Injection site observation, Immune rejection test
- Secondary Outcome Measures
Name Time Method Recovery rate (%) day 7, 14, 21, 28 days and week 8 A digital photograph day 1, 3, 7, 14, 21, 28, week 8 and week 12 Patient satisfaction week 12
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of