RECELL System Cleared for Skin Repigmentation in Patients With Vitiligo

The Food and Drug Administration (FDA) has approved the RECELL^® System for the treatment of vitiligo.

The RECELL System is a single-use, autologous cell harvesting device intended for use at the point of care by a trained health care professional. The device allows for the delivery of autologous skin cells from pigmented skin to stable depigmented areas.

The approval was based on data from a trial that investigated the safety and efficacy of the RECELL System for repigmentation of stable vitiligo lesions (ClinicalTrials.gov Identifier: NCT04547998). Study participants were randomly assigned to treatment with RECELL or standard of care (control). Repigmentation was evaluated by an expert central review committee.

Findings showed that 36% of RECELL treatments resulted in repigmentation of at least 80% of the treated area at 6 months (primary endpoint) compared with 0% of control treatments (P <.025). At 6 months, 68% of patients had physician-reported RECELL treatment success, and 80% had self-reported treatment success.

“RECELL represents first-in-class treatment for repigmentation through the delivery of normal, healthy skin cells,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “This is a breakthrough approval for AVITA Medical, significantly expanding the clinical applications for RECELL, and demonstrates our continued commitment to patient care. We look forward to offering a meaningful one-time treatment option for patients with stable vitiligo across the US.”

The RECELL System is also indicated for the treatment of severe burns in adults and pediatric patients, and for full-thickness skin defects.