Avita Therapeutics, a regenerative medicine company, has launched a clinical study to evaluate the safety and effectiveness of its RECELL® System in treating vitiligo.
The RECELL system uses a small amount of a patient’s healthy skin to prepare a suspension of Spray-On Skin™ Cells, which is then applied to the vitiligo. According to Avita Therapeutics, a previous randomized controlled study utilizing the Spray-On Skin™ Cells resulted in 100% repigmentation in the treated area at six months. The new study will focus on long-term safety and effectiveness, including sustained repigmentation.
The clinical study will test the safety and effectiveness of the RECELL System at 24 weeks in patients with stable vitiligo. The study will be hosted at sites across the Unites States including the Miami Dermatology and Laser Institute. Avita Therapeutics is also partnering with the University of Massachusetts Medical School to conduct a vitiligo feasibility study.
The RECELL® System was approved by the U.S. Food and Drug Administration in September 2018.