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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 for the treatment of bilateral nasolabial fold wrinkles, which are the creases that run from the sides of the nose to the corners of the mouth. It is an investigational therapy being developed by Castle Biosciences, Inc. for this cosmetic indication.
Autologous Human Fibroblast is a cell-based therapy that uses a patient's own fibroblasts, which are cells that produce collagen and other structural components of the skin. When injected into the nasolabial folds, these fibroblasts are intended to help restore volume and reduce the appearance of wrinkles.
Autologous Human Fibroblast is being developed by Castle Biosciences, Inc., a company traded on the NASDAQ under the ticker symbol CSTL. The company is conducting clinical trials to evaluate the safety and efficacy of this therapy for nasolabial fold wrinkles.
Autologous Human Fibroblast is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 3 trial has been completed, and the results will determine whether the therapy can proceed to regulatory submission.
Autologous Human Fibroblast has one completed Phase 3 clinical trial with the identifier NCT00649428. This trial, titled 'Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles,' enrolled 203 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, Autologous Human Fibroblast is the same as Isolagen Therapy. The Phase 3 clinical trial NCT00649428 refers to the treatment as Isolagen TherapyTM, which is the brand name for this autologous fibroblast therapy developed by Castle Biosciences, Inc.