- Hamzavi, Iltefat H;
- Ganesan, Anand K;
- Mahmoud, Bassel H;
- Weiss, Eduardo;
- Ahmed, Ammar M;
- Robinson, Deanne;
- Goldman, Mitchel P;
- Munavalli, Girish;
- Kahn, Steven A;
- Huang, Victor;
- Waibel, Jill;
- Desai, Alpesh;
- Elbuluk, Nada;
- Desai, Seemal;
- Pandya, Amit G
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.