AVITA Therapeutics has launched a study evaluating their RECELL System as a treatment for stable vitiligo.
AVITA Therapeutics announced they have enrolled the first patient in their study evaluating the safety and efficacy of their RECELL System to treat stable vitiligo.
Approved by the U.S. Food and Drug Administration (FDA) in September 2018 for the treatment of acute thermal burns in adult patients, the RECELL System works by preparing Spray-On Skin Cells, an autologous suspension utilizing the patient’s skin cells that is then sprayed onto targeted areas of the patient’s skin to help regenerate a healthy epidermis.
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“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,” says Mike Perry, M.D., CEO of AVITA Therapeutics. “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.”
During the study, researchers at the Miami Dermatology and Laser Institute in Miami, Fla., will evaluate the RECELL System in depigmented vitiligo lesions at 24 weeks in patients with stable vitiligo. Stable vitiligo is defined as patients who have not experienced new vitiligo lesions or growth of existing lesions for a minimum of one year.
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Researchers will collect a small portion of patients’ healthy skin at the point-of-care in order to prepare suspension of Spray-On Skin Cells with the RECELL System that will later be applied to the vitiligo lesion. Data collected during the study will be examined for long-term safety, efficacy and sustained repigmentation of vitiligo lesions, according to the press release.
“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,” says Jill Waibel, M.D., 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 company is also working with the University of Massachusetts Medical School on a complementary and scientifically-oriented vitiligo feasibility study that coincides with their current study involving the RECELL System.
First Patient Enrolled in AVITA Therapeutic's Pivotal Study Evaluating the RECELL System for Repigmentation of Stable Vitiligo. (2020, September 14). Retrieved September 18, 2020, from https://www.businesswire.com/news/home/20200914005335/en/First-Patient-Enrolled-in-AVITA-Therapeutic%E2%80%99s-Pivotal-Study-Evaluating-the-RECELL-System-for-Repigmentation-of-Stable-Vitiligo