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

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).

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 (52 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 (52 weeks).
• The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation in the study (52 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 -