Feasibility Study to Evaluate RECELL and Melanocyte Keratinocyte Transplantation Procedure for Repigmentation of Stable Vitiligo Lesions

Inclusion Criteria

• •Subjects must meet all of the following criteria to be eligible:
• •1. Focal, segmental or generalized (i.e., nonsegmental) vitiligo documented as stable (no new lesions nor lesions expanding in size within the preceding 12 months, regardless of whether the lesions are intended for treatment in this study).
• •2. The patient has not undergone topical treatment (e.g., steroids) for the study lesion within the past 60 days.
• •3. The patient has not undergone phototherapy (e.g., NB-UVB) for the study lesion within the past 6 months.
• •4. The patient is a candidate for surgical intervention for treatment of a depigmented area, defined as: the patient has been compliant but has not satisfactorily responded to topical therapy and a minimum of 3 months of phototherapy.
• •5. Five discrete 3cm by 3cm areas are available for treatment within the depigmented lesion.
• •6. The 5 study areas must be similarly sun exposed.
• •7. The extent of leukotrichia must be similar between the five study areas.
• •8. The patient is ≥ 22 years of age.
• •9. The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up evaluations required by the study protocol.
• •10. The patient agrees to abstain from any other treatment of the study areas for the duration of the his/her participation in the study (24 weeks).
• •11. 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).
• •12. In the opinion of the investigator, the patient and/or guardian must be able to:
• •1. Understand the full nature and purpose of the study, including possible risks and adverse events,
• •2. Understand instructions, and
• •3. Provide voluntary written informed consent.