Effective and durable repigmentation for stable vitiligo: A randomized within-subject controlled trial assessing treatment with autologous skin cell suspension transplantation - 20/11/24
, Anand K. Ganesan, MD, PhD b, Bassel H. Mahmoud, MD, PhD c, Eduardo Weiss, MD d, Ammar M. Ahmed, MD e, Deanne Robinson, MD f, Mitchel P. Goldman, MD g, Girish Munavalli, MD h, Steven A. Kahn, MD i, Victor Huang, MD j, Jill Waibel, MD k, Alpesh Desai, DO l, Nada Elbuluk, MD, MSc m, Seemal Desai, MD n, o, Amit G. Pandya, MD pAbstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : autologous cell transfer, autologous skin cell suspension, cellular grafting, melanocyte transfer, noncultured skin cell suspension, procedural dermatology, repigmentation, vitiligo, vitiligo surgery
Abbreviations used : AE, ASCS, CRC, F-VASI, FDA, MKT, US
Plan
| Funding sources: AVITA Medical. |
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| Patient consent: Consent for the publication of recognizable patient photographs or other identifiable material was obtained via the informed consent process and is available upon request. |
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| IRB approval status: Each study site had institutional review board oversight. |
Vol 91 - N° 6
P. 1104-1112 - décembre 2024 Retour au numéro
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