Spray-On Skin Cells for Vitiligo

(TONE Trial)

No longer recruiting at 21 trial locations

Overseen By Gilly Munavalli, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Avita Medical

Must be taking: Immunosuppressive therapy

Must not be taking: Anticoagulants

Disqualifiers: Keloid history, Lip-tip vitiligo, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for people with stable vitiligo, a condition where skin loses its color in patches. The RECELL® Autologous Cell Harvesting Device sprays skin cells to restore color and improve quality of life. Participants will use this device and follow up with light therapy at home. This trial targets individuals who have not seen results from other treatments and whose vitiligo has remained unchanged for a year. Eligible participants should have a specific type of vitiligo with characteristics such as a depigmented area that is mostly white or colorless. As an unphased trial, this study offers a unique opportunity to explore a novel treatment approach for vitiligo.

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 prior data suggests that the RECELL Device is safe for treating vitiligo?

Research has shown that the RECELL Autologous Cell Harvesting Device is generally safe for treating vitiligo. Studies have found it well-tolerated and effective in restoring color to affected skin. The reviewed safety data reveal no major concerns. Patients have reported positive feedback, noting improvements in both skin color and overall quality of life.

In summary, current evidence suggests the treatment is safe, with no major side effects reported in the reviewed studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for vitiligo, which often involve topical creams or light therapy, the RECELL® Autologous Cell Harvesting Device uses a spray-on method to apply a suspension of the patient's own skin cells directly onto the affected area. This technique has the potential to promote repigmentation more effectively by delivering live skin cells right where they are needed. Researchers are excited because this method could lead to faster and more targeted results compared to traditional approaches, potentially offering a new hope for individuals with vitiligo.

What evidence suggests that the RECELL Device is effective for vitiligo?

Research has shown that the RECELL Autologous Cell Harvesting Device effectively treats stable vitiligo. In this trial, participants will receive a skin cell suspension prepared using the RECELL System, applied to a prepared treatment area, followed by at-home NB-UVB phototherapy. By week 24 of treatment, 67% of patients in previous studies regained more than half of their skin color. Additionally, 42% of patients had at least 80% of their skin color return, and 8% experienced complete repigmentation. The device sprays the patient's own skin cells onto the affected areas, complemented by at-home light therapy. Overall, these results suggest the treatment can significantly improve skin color in vitiligo patches. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

I understand the study's purpose, can complete questionnaires, and agree to participate.

My vitiligo is stable and not spreading.

Patient agrees to abstain from any other treatment of the study area and enrollment in any other interventional clinical trial

Exclusion Criteria

Patient has a known hypersensitivity to specific substances

I cannot prepare the treatment area by myself.

I am not on any medication or have conditions that could risk my safety in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Skin cell suspension prepared using the RECELL System is applied to a prepared treatment area, followed by at-home NB-UVB phototherapy

4 weeks

Follow-up

Participants are monitored for repigmentation and quality of life after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RECELL® Autologous Cell Harvesting Device

Trial Overview The RECELL Device is being tested to see if it can repigment skin affected by vitiligo and improve patients' quality of life. The device uses a patient's own cells to create a spray-on treatment applied to depigmented areas.

How Is the Trial Designed?

Group I: Study Treatment Experimental Treatment 1 Intervention

Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy.

Who Is Running the Clinical Trial?

Avita Medical

Lead Sponsor

Trials

18

Recruited

720+

Citations

1. fda.gov fda.gov/media/174803/download

RECELL Autologous Cell Harvesting Device (Model Number The RECELL Autologous Cell Harvesting Device is indicated for repigmentation of stable depigmented vitiligo lesions in patients 18 years of age ...

2. jaad.org jaad.org/article/S0190-9622(25)00536-5/fulltext

Autologous cell harvesting device provides repigmentation ... By week-24, all lesions demonstrated improvement; 67% achieved >50% repigmentation, 42% achieved ≥80% repigmentation, and 8% achieved complete ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0190962224027130

Effective and durable repigmentation for stable vitiligo: A ... Among 25 subjects, 36% of ASCS-treated lesions achieved ≥80% repigmentation at week-24 compared to 0% for Control (P < .025), with durability through week-52.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40158537/

Autologous cell harvesting for vitiligo repigmentation By week-24, all lesions demonstrated improvement; 67% achieved >50% repigmentation, 42% achieved ≥80% repigmentation, and 8% achieved complete repigmentation.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05971381

Repigmentation of Stable Vitiligo Lesions Using Spray-On ... Prospective, multicenter single-arm pre-/post interventional study to evaluate the clinical performance of RECELL for repigmentation of stable depigmented ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11186709/

A systematic review and meta‐analysis of randomized trials This suggests that the ReCell technique is a simple, safe, and effective treatment for vitiligo plaques, burn wounds and a range of other acute ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0190962225005365

Autologous cell harvesting device provides repigmentation ... ASCS is highly effective for repigmentation of stable vitiligo lesions, with positive patient-reported outcomes and improvement in quality-of-life.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02458417

Autologous Cell Suspension Grafting Using ReCell in ... The purpose of this study is to assess the efficacy and safety of ReCell grafting after CO2 laser abrasion with superficial full surface ablation, ...