Approval Probability
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Autologous Human Fibroblasts · 4 trials · 4 indications
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.
Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.
Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.
Subject Wrinkle Assessment was a five point ordinal scale that assessed the subject's assessment of the appearance of their face. A score of -2 (very dissatisfied) was the worst and a score of +2 (very satisfied) was the best.
An independent panel of physicians reviewed photographs of subjects at baseline and 6 months after final study treatment and provided a score for improvement in appearance on the Global Improvement Assessment. The Global Improvement Assessment was a four point ordinal scale with 0 (No improvement) as the worst score and 3 (Marked Improvement) the best.
A patient was considered a responder in this outcome measure if the average Investigator's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best.
A patient was considered a responder in this outcome measure if the average patient's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best.
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Double blinded active | EXPERIMENTAL | Subject will receive autologous fibroblast treatment on either their left or right side of their face |
| Double blinded placebo | PLACEBO_COMPARATOR | Subject will receive placebo treatment on the opposite side of the face from active treatment |
| Name | Type | Description |
|---|---|---|
| Autologous Human Fibroblasts (azficel-T) | BIOLOGICAL | 1. Collection of 3 mm post auricular skin punch biopsies. 2. Three treatment visits with injections 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 treatment visits with injections 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 Fibroblasts is an investigational cell therapy being developed for dermatological conditions including acne scarring of the face, interdental papillary insufficiency, bilateral nasolabial fold wrinkles, and facial wrinkles and creases. It is currently in clinical development and has not been approved by the FDA.
Autologous Human Fibroblasts is a cell-based therapy that uses a patient's own fibroblasts, which are cells that produce collagen and other extracellular matrix components. The therapy is designed to restore or augment tissue volume and structure in areas affected by wrinkles, scars, or other dermal imperfections.
Autologous Human Fibroblasts is being developed by Castle Biosciences, Inc., a company publicly traded under the ticker symbol CSTL. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for various dermatological indications.
Autologous Human Fibroblasts is in Phase 2 clinical development, with some trials having progressed to Phase 3. The therapy is investigational and has not received FDA approval. Clinical trials have been completed for facial acne scarring, facial wrinkles and creases, nasolabial fold wrinkles, and interdental papillary insufficiency.
Autologous Human Fibroblasts has been studied in several completed clinical trials, including NCT00642642 for severe facial acne scarring, NCT00654654 for facial wrinkles and creases, NCT00655356 for bilateral nasolabial fold wrinkles, and NCT00655889 for interdental papillary insufficiency. These trials were conducted in the United States.
Yes, Autologous Human Fibroblasts is also known as Isolagen Therapy, as referenced in several clinical trial titles. This investigational cell therapy is being developed by Castle Biosciences, Inc. for various dermatological conditions, including facial wrinkles and nasolabial fold wrinkles.