The feasibility study will evaluate the safety and effectiveness of its RECELL System for repigmentation of depigmented lesions related to stable vitiligo
The US FDA centre for devices and radiological health. Credit: The U.S. Food and Drug Administration/Wikipedia.
AVITA Medical has received the US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for a feasibility study of its RECELL Autologous Cell Harvesting Device (RECELL System).
The UK-based regenerative medicine company will conduct the feasibility study to evaluate the safety and effectiveness of its RECELL System for repigmentation of depigmented lesions related to stable vitiligo.
AVITA Medical chief executive officer Mike Perry said: “Vitiligo affects approximately 6.5 million people in the United States, rivalling the prevalence of psoriasis; however, there are limited treatment options available to patients to permanently restore skin pigmentation.
“We’re pleased with the FDA’s decision which allows us to begin our vitiligo study in the first half of 2020. Based on the outcomes of the feasibility study, we anticipate proceeding with a pivotal clinical trial to pursue FDA approval of the RECELL System as a cell-based repigmentation treatment option for stable vitiligo.”
RECELL System is indicated for patients undergoing reconstruction of skin defects
According to the company, vitiligo is a disease characterised by pigmentation (colour loss) in patches of skin, and the condition potentially impacts the quality of life in people. Currently, vitiligo has no cure, or a universally accepted method to prevent the spread of the disease.
AVITA Medical said that in partnership with a medical centre, it will conduct a pilot study on 10 patients with vitiligo lesions that have been stable for at least one year.
In the pilot study, the areas of the vitiligo lesion will be randomly treated with slightly varying cell suspensions prepared using RECELL to measure the response rates and optimal suspension parameters.
The percent area of repigmented skin 24 weeks after treatment, evaluated by a clinician blinded to the treatment assignment is the primary effectiveness measure of the study.
In addition, the study includes collection of effectiveness data, including degree of repigmentation achieved and patient rating of repigmentation, over a period of 24-weeks.
According to the US Federal law, the use of RECELL System for patients undergoing reconstruction of skin defects, not associated with a burn injury, is restricted to investigational use only.
AVITA Medical chief technology officer Andy Quick said: “This study expands on peer-reviewed, published effectiveness outcomes to confirm the feasibility of RECELL as a treatment for repigmentation in cases of stable vitiligo.
“Given the RECELL System’s broad approval outside of the U.S., more than 1,000 vitiligo patients have already been treated globally and reported repigmentation.”