Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells (TONE)
Vitiligo
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring focal vitiligo, segmental vitiligo, nonsegmental vitiligo, generalized vitiligo
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 -
Sites / Locations
- Affiliated DermatologyRecruiting
- University of California, IrvineRecruiting
- University of Southern California
- University of California, Davis
- West Dermatology Research CenterRecruiting
- California Dermatology Institute
- Clarity DermatologyRecruiting
- Skin Care Research, LLCRecruiting
- University Medical Center
- Dermatologic Surgery Center of WashingtonRecruiting
- University Of MassachusettsRecruiting
- Hamzavi DermatologyRecruiting
- Henry Ford Health
- Grekin Skin Institute
- Mount Sinai
- Dermatology, Laser and Vein Specialists of the CarolinasRecruiting
- University of Texas at Austin
Arms of the Study
Arm 1
Other
Study Treatment
Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy.