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Also known as Autologous Human Fibroblast (azficel-T)
Autologous Human Fibroblast · 1 trial · 1 indication
A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.
A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | - |
| Control | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Autologous Human Fibroblast (azficel-T) | BIOLOGICAL | 1. Collection of 3 mm post auricular skin punch biopsies. 2. Three injection treatments administered 5 ± 1 weeks apart on each side of the face. |
| Placebo | BIOLOGICAL | 1. Collection of 3 mm post auricular skin punch biopsies. 2. Three injection visits administered 5 ± 1 weeks apart on each side of the face. |
Inclusion Criteria: * Subject is at least 18 years of age * Level of severity of bilateral nasolabial fold wrinkles meeting severity criteria as per protocol * Level of subject dissatisfaction with both nasolabial fold wrinkles as per protocol * Ability to comply with the study requirements * Negat...
Autologous Human Fibroblast is used to treat bilateral nasolabial fold wrinkles, the lines that run from the nose to the corners of the mouth. It is a cell therapy given to reduce the appearance of these wrinkles. The product is also known as azficel-T.
Autologous Human Fibroblast targets ADA, an exogenous gene target. The therapy uses a patient's own fibroblasts, which are cells that produce collagen and other structural components of skin. By introducing these cells, the treatment aims to improve the skin's structure at the treated site.
Autologous Human Fibroblast is being developed by Castle Biosciences, Inc., which trades under the ticker CSTL. The company is responsible for the clinical program evaluating this cell therapy for bilateral nasolabial fold wrinkles.
Autologous Human Fibroblast is in Phase 3 clinical development. It is an investigational cell therapy and has not been approved by the FDA. The Phase 3 trial for this product has been completed.
Autologous Human Fibroblast has been studied in one Phase 3 clinical trial, NCT00649428, titled Safety and Efficacy Study of Isolagen Therapy in the Treatment of Nasolabial Fold Wrinkles. The trial was completed, enrolled 203 participants, and was randomized, double-blind, and placebo-controlled.
Yes, Autologous Human Fibroblast is also known as azficel-T. Both names refer to the same cell therapy developed by Castle Biosciences, Inc. for bilateral nasolabial fold wrinkles.