Spray-On Skin Cells for Vitiligo

(TONE Trial)

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

109 Participants Needed

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. ^{1 2 3 4 5}

Is the spray-on skin cell treatment safe for humans?

The spray-on skin cell treatment, also known as the ReCell system, has been shown to be safe in studies for treating stable vitiligo. It is a simple and safe technique with low rates of complications, and it does not require complex laboratory facilities. ^{1 2 5 6 7}

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. ^{1 8 9 10 11}

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

My vitiligo is stable and not spreading.

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

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

Exclusion Criteria

I cannot prepare the treatment area by myself.

Patient has a known hypersensitivity to specific substances

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Epidermal skin grafting in vitiligo: a pilot study. [2021]

2. Italy pubmed.ncbi.nlm.nih.gov

Treatment of stable vitiligo hands by ReCell system: a preliminary report. [2010]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Quantitative Outcome Assessment of Color Match and the Extent of Repigmentation after Pixel Array Epidermal Grafting for Head and Neck Stable Vitiligo: A Prospective Cohort Study. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

Epidermal curettage technique (ECT) for tissue harvest from the donor area for melanocyte autologous grafting in cases of vitiligo. [2021]

5. India pubmed.ncbi.nlm.nih.gov

Autologous Non-cultured Basal Cell-Enriched Epidermal Cell Suspension Transplantation in Vitiligo: Indian Experience. [2021]

6. Croatia pubmed.ncbi.nlm.nih.gov

Treatment of stable vitiligo by ReCell system. [2011]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of autologous transplantation of noncultured epidermal suspension in two different dilutions in the treatment of vitiligo. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Development of a plasma-polymerized surface suitable for the transplantation of keratinocyte-melanocyte cocultures for patients with vitiligo. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Autologous cell suspension grafting in segmental vitiligo and piebaldism: a randomized controlled trial comparing full surface and fractional CO2 laser recipient-site preparations. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Transplantation of autologous epidermal melanocyte-keratinocyte cells suspension for cell therapy of vitiligo: A clinical evaluation and biometric assessment. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Noncultured extracted hair follicle outer root sheath cell suspension for transplantation in vitiligo. [2022]