Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells

Study Overview
=================
Brief Summary
-----------------
To evaluate repigmentation and quality of life after treatment of stable vitiligo lesions using the RECELL Device.

Detailed Description
-----------------
Prospective, multicenter single-arm pre-/post interventional study to evaluate the clinical performance of RECELL for repigmentation of stable depigmented lesions.Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy. Repigmentation of treatment areas will be determined via centralized image interpretation by an expert dermatological panel (i.e., Central Review Committee, CRC).

Official Title
-----------------
The TONE Study: A Prospective Post-Market Clinical Study Investigating Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Device: RECELL® Autologous Cell Harvesting Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Focal, segmental, or generalized (i.e., nonsegmental) stable vitiligo, defined as no new depigmented areas nor any depigmented areas that have expanded in size within the preceding 12 months. The patient is a candidate for surgical intervention of a depigmented area, defined as a patient who has not satisfactorily responded to either: topical therapy or a minimum of 3 months of phototherapy. The patient has a depigmented area available for treatment that is: ≥90% depigmented, without any other dermatologic conditions (other than vitiligo), and excludes the lips, eyelids, plantar surface of feet, palmar surface of hands. The patient is 18 years of age or older. The patient agrees to remain on any current use of immunosuppressive therapy for the duration of his/her participation in the study (24 weeks). The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up study visits. The patient agrees to abstain from any other treatment of the study area for the duration of his/her participation in the study (24 weeks). The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation in the study (24 weeks). In the opinion of the investigator, the patient must be able to: Understand the full nature and purpose of the study, including possible risks and benefits, Understand instructions and be able to comprehend and complete study questionnaires, and Provide voluntary written informed consent. - Exclusion Criteria: The patient is unable to undergo treatment area preparation. Patients who received RECELL treatment for vitiligo in Protocol No. CTP008 or CTP009. Patients with: depigmented lips and fingertips (lip-tip vitiligo), or depigmented areas over >30% of their body surface area. Patients with recent history (within previous 12 months) of: Koebnerization, confetti-like, or trichrome lesions. Patients with a history of keloid formation. The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives. Current use of medications (e.g., anticoagulants such as heparin or warfarin) that in the investigator's opinion may compromise patient safety or trial objectives. The patient has a known hypersensitivity to trypsin, compound sodium lactate for irrigation solution (Hartmann's solution), povidone-iodine, chlorhexidine, and/or lidocaine-containing anesthetics -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study Treatment<br>Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy. | Device: RECELL® Autologous Cell Harvesting Device<br>* The RECELL Device is for use at the patient's point-of-care for the safe and rapid preparation of Spray-On SkinTM Cells from a small sample of a patient's own skin.<br>* Other names: Spray-On SkinTM Cells;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repigmentation 26-50%, 51-79%, 80-99%, and 100%) | Central Review Committee categorization of index area repigmentation | 24 weeks post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
focal vitiligo, segmental vitiligo, nonsegmental vitiligo, generalized vitiligo