Spray-On Skin Cells for Vitiligo
(TONE Trial)
Trial Summary
What is the purpose of this trial?
This trial tests a new treatment for people with stable vitiligo, a condition where patches of skin lose their color. The treatment uses the RECELL Device to create a mixture of the patient's own skin cells, which is then applied to the discolored areas. Patients also use a special light therapy at home to help improve the results.
Will I have to stop taking my current medications?
The trial requires that you stay on any current immunosuppressive therapy for the duration of the study. However, if you are taking medications like anticoagulants, you may need to stop if the investigator thinks they could affect your safety or the study's goals.
What data supports the effectiveness of the treatment RECELL® Autologous Cell Harvesting Device for vitiligo?
Research shows that the RECELL system, used for stable vitiligo, can be effective in repigmentation, as it involves harvesting skin cells that help restore color to affected areas. Similar techniques, like epidermal skin grafting, have been shown to be safe and effective in improving the appearance of vitiligo.12345
Is the spray-on skin cell treatment safe for humans?
How does the RECELL® Autologous Cell Harvesting Device treatment for vitiligo differ from other treatments?
The RECELL® Autologous Cell Harvesting Device is unique because it involves spraying a suspension of a patient's own skin cells onto the affected area, which can accelerate repigmentation without the need for painful surgical procedures or local anesthesia, unlike traditional skin grafting methods.1891011
Eligibility Criteria
This trial is for adults with stable vitiligo, which hasn't changed in the past year. They should have tried topical therapy or phototherapy without success and be willing to stick to their current immunosuppressive drugs and at-home phototherapy during the study. Participants must not use other treatments or join another trial for 24 weeks.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Skin cell suspension prepared using the RECELL System is applied to a prepared treatment area, followed by at-home NB-UVB phototherapy
Follow-up
Participants are monitored for repigmentation and quality of life after treatment
Treatment Details
Interventions
- RECELL® Autologous Cell Harvesting Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
Avita Medical
Lead Sponsor