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

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.