Depressed Scar
Conditions
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.
Interventions
DRUGAdipocell
autologous cultured adipocytes (ANTG-adip)
Sponsors
Anterogen Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: recovery rate(%) | week 12 |
| Safety: clinically measured abnormality of laboratory tests and adverse events, Injection site observation, Immune rejection test | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed