VAVELTA®, a suspension of human dermal fibrolasts for skin disease

VAVELTA® is a skin repair and rejuvenation product, made from human dermal fibroblasts (derived from neonatal foreskin) stored in a cell storage medium called HypoThermosol®-FRS. It is being developed primarily for medical applications, but has also demonstrated utility in aesthetic applications. It has been designed to improve the structure, function and appearance of skin damaged by scarring or aging, and is used to treat skin diseases such as restrictive scar contracture due to burn and dystrophic epidermolysis bullosa. Several clinical trials have been conducted (Phase I and II). A Phase I study showed VAVELTA® to be very well tolerated; no serious adverse events were reported and all adverse events were transient and resolved without treatment. A Phase II dose-escalation trial of VAVELTA® in nasolabial folds, showed average satisfaction scores for both dosage treatment groups and improvement in wrinkle severity in 12 subjects (75%). A second Phase II trial testing VAVELTA in acne scarring demonstated average satisfaction scores for the treatment, as assessed separately by both subjects and the investigator on a scale of one to ten (ten being the highest). Scorings were 6.8 and 6.3 for patients and investigator, respectively.