The study will evaluate the safety and effectiveness of AVITA Therapeutic’s RECELL System to repigment skin in patients who have vitiligo that has been stable for at least one year
AVITA Therapeutics, a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today the initiation of the pivotal study assessing the use of the RECELL System to treat stable vitiligo with the enrollment of the first patient at Miami Dermatology and Laser Institute in Miami, FL. The study will evaluate the safety and effectiveness of AVITA Therapeutic’s RECELL System to repigment skin in patients who have vitiligo that has been stable for at least one year.
“The initiation of the vitiligo clinical study is a milestone in advancing AVITA Therapeutic’s pipeline to leverage the utility and full potential of our innovative RECELL technology platform to address unmet medical needs in dermatological applications,” said Dr. Mike Perry, AVITA Therapeutic Chief Executive Officer. “Globally, there have been several published case series and pilot randomized clinical trials reporting positive results with the use of RECELL for treating patients with stable vitiligo and repigmenting depigmented skin lesions. We are pleased to initiate this pivotal study as a next step toward offering a treatment option for the millions of Americans who live with vitiligo.”
Vitiligo is an autoimmune disease that attacks the epidermis layer of skin resulting in loss of color or pigmentation. This serious skin condition affects up to 2% of the population worldwide, including an estimated 6.5 million Americans. Vitiligo has a comparable market size & psychosocial impact to other major dermatology diseases including psoriasis (thick, scaly skin) and atopic dermatitis (red, cracked skin). IV-VI Like these diseases, patients with vitiligo may suffer from poor body image along with low self-esteem, leading to an impaired quality of life. There is currently no cure for vitiligo, nor a universally accepted method for limiting the spread of the disease. Although many treatments are being used for the management of vitiligo, they are often temporary with a high rate of recurrence.
“While often considered a cosmetic issue, vitiligo can greatly impact the quality of life of those living with the disease, and treatment options are limited,” said Jill Waibel, MD, owner and Medical Director of Miami Dermatology and Laser Institute. “We look forward to assessing the safety and efficacy of the RECELL System in restoring skin color in stable vitiligo lesions and potentially offering those who live with vitiligo hope with a new, easy in-office treatment.”
The multi-center pivotal study will assess the safety and effectiveness of the RECELL System in treatment of depigmented vitiligo lesions at 24 weeks in patients whose vitiligo is stable, meaning they have not had new vitiligo lesions or lesions that have expanded for at least one year. Clinicians will obtain a small amount of the study participant’s own healthy skin at the point-of-care to prepare a suspension of Spray-On Skin Cells using the RECELL System that will then be applied to the vitiligo lesion. Additional long-term safety and effectiveness data, including sustained repigmentation of the vitiligo lesion, will be collected over the course of the study.
In parallel with the clinical study, AVITA Therapeutics is partnering with the University of Massachusetts Medical School on a complementary and more scientifically-oriented vitiligo feasibility study.
Of note: Use of the RECELL System in patients undergoing reconstruction of skin defects not associated with a burn injury is limited by the Federal law to investigational use.
Source: Company Press Release