Effective and durable repigmentation for stable vitiligo: A randomized within-subject controlled trial assessing treatment with autologous skin cell suspension transplantation.

Autor: Hamzavi IH; Department of Dermatology, Henry Ford Health System, Dermatology Research, Detroit, Michigan. Electronic address: IHAMZAV1@hfhs.org., Ganesan AK; Department of Dermatology, University of California Irvine, Irvine, California., Mahmoud BH; Department of Dermatology, University of Massachusetts, Worcester, Massachusetts., Weiss E; Skin Care Research, Hollywood, Florida., Ahmed AM; Department of Internal Medicine, Dell Medical School at the University of Texas at Austin, Austin, Texas., Robinson D; DMR Research PLLC, Westport, Connecticut., Goldman MP; Cosmetic Laser Dermatology: A Platinum Dermatology Partners Company, San Diego, California., Munavalli G; Dermatology, Laser, & Vein Specialists of the Carolinas, Charlotte, North Carolina., Kahn SA; Department of Surgery, Medical University of South Carolina, Charleston, South Carolina., Huang V; Department of Dermatology, University of California, Sacramento, California., Waibel J; Miami Dermatology & Laser Research, Miami, Florida., Desai A; Heights Dermatology & Aesthetic Center, Houston, Texas., Elbuluk N; Department of Dermatology, Keck School of Medicine USC, Los Angeles, California., Desai S; Innovative Dermatology, Plano, Texas; Department of Dermatology, The University of Texas Southwestern Medical Center, Dallas, Texas., Pandya AG; Palo Alto Foundation Medical Group, Sunnyvale, California.
Jazyk: angličtina
Zdroj: Journal of the American Academy of Dermatology [J Am Acad Dermatol] 2024 Dec; Vol. 91 (6), pp. 1104-1112. Date of Electronic Publication: 2024 Sep 07.
DOI: 10.1016/j.jaad.2024.08.027
Abstrakt: Background: Vitiligo lesions are often challenging to repigment with conventional medical therapies. Surgical autologous melanocyte transfer methods can be utilized for stable vitiligo but demand specialized skills and equipment. A point-of-care autologous cell harvesting device was designed enabling simple preparation of autologous skin cell suspension (ASCS) containing melanocytes, keratinocytes, and fibroblasts providing a straightforward approach for cellular transplantation.
Objective: To evaluate the safety and effectiveness of ASCS for repigmentation of stable vitiligo lesions among adults.
Methods: A US multicenter, randomized, within-subject controlled trial compared ASCS to narrow band ultraviolet B only (Control) in similar vitiligo lesions. ASCS was applied after laser skin resurfacing and followed by narrow band ultraviolet B treatment. The primary effectiveness endpoint was the proportion of lesions achieving ≥80% repigmentation at week-24. Repigmentation durability was assessed at week-52.
Results: Among 25 subjects, 36% of ASCS-treated lesions achieved ≥80% repigmentation at week-24 compared to 0% for Control (P < .025), with durability through week-52. The safety profile of ASCS was acceptable, with favorable patient- and investigator-reported outcomes.
Limitations: Study sample size limited robust subgroup analyses.
Conclusion: Application of ASCS has potential as a treatment for repigmentation of stable vitiligo lesions with the potential to improve health-related quality of life and reduce burden of disease.
Competing Interests: Conflicts of interest Dr Hamzavi has served as an advisory board member for AbbVie; a consultant for Boehringer Ingelheim, AVITA Medical, Galderma Laboratories LP, Incyte, Pfizer, and UCB; a principal investigator for AVITA, Bayer, Estée Lauder, Ferndale Laboratories, Incyte Corporation, Lenicura, L’Oréal, Pfizer, and Unigen; immediate past president of the HS Foundation; and a board member of the Global Vitiligo Foundation. Dr Ganesan is an investigator for AVITA and AbbVie. Dr Mahmoud is an investigator for AVITA. Dr Munavalli is an investigator and speaker for AVITA. Dr Kahn is an investigator and speaker for AVITA and Vericel Inc, a DSMB consultant for Polynovo, and an investigator and medical monitor for Spectral MD. Dr Huang has served on an advisory panel for Incyte and as an investigator for Abbvie. Dr Waibel has served as an advisory board member for Bellamia, Cytrellis Biosystems, and RegenX; a consultant for Allergan, Candela, Cytrellis Biosystems, P&G, Skinceuticals, and Turn.Bio; an investigator for Amgen, ArgenX, Bristol Myers Squibb, Cytrellis Biosystems, Eli Lily, Emblation, Galderma, Horizon, Janssen, Neuronetics, Pfizer, RegenX, Sanofi, Skincueticals, and Shanghi Biopharma, PWB; a speaker for Candela and Eli Lily; she has received a Veterans Affairs Merit Grant - Amputated Veterans. Dr Elbuluk has served as a consultant, advisory board member, and/or speaker for AVITA, Incyte, VisualDx, La Roche Posay, Beiersdorf, Unilever, Allergan, Eli Lilly, Galderma, Pfizer, Takeda, AbbVie, Janssen, Sanofi, L’Oreal, McGraw Hill, Dior, Medscape; she has grant funding from Pfizer, has received royalties from McGraw-Hill and has stock options in VisualDx. Dr Pandya has served as an investigator for Incyte, AVITA, Clinuvel; a consultant for AbbVie, AVITA, Boehringer Ingelheim, Immune Tolerance Network, Incyte, Lilly, Pfizer, Sun, Thalocan, WCG, Villaris, Vimela, Vyne; and has partial owndership of Tara Medical. Drs Weiss, Ahmed, Robinson, Goldman, A. Desai and S. Desai have no conflicts of interest to declare.
(Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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