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

Ki vehet részt

• 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. -

Ki nem vehet részt

• Patients who received RECELL treatment for vitiligo in Protocol No. CTP008 or CTP009
• Patients with recent history (within previous 12 months) of:; Koebnerization,; confetti-like, or; trichrome lesions
• 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
• Patients with a history of keloid formation
• 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 -
• The patient is unable to undergo treatment area preparation
• Patients with:; depigmented lips and fingertips (lip-tip vitiligo), or; depigmented areas over >30% of their body surface area