This study was funded by Reliance Life Sciences.
Efficacy and Safety of Autologous Cultured Melanocytes Delivered on Poly (dl-Lactic Acid) Film: A Prospective, Open-Label, Randomized, Multicenter Study
Article first published online: 1 OCT 2012
© 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.
Volume 38, Issue 12, pages 1981–1990, December 2012
How to Cite
Ghosh, D., Kuchroo, P., Viswanathan, C., Sachan, S., Shah, B., Bhatt, D., Parasramani, S. and Savant, S. (2012), Efficacy and Safety of Autologous Cultured Melanocytes Delivered on Poly (dl-Lactic Acid) Film: A Prospective, Open-Label, Randomized, Multicenter Study. Dermatologic Surgery, 38: 1981–1990. doi: 10.1111/dsu.12000
- Issue published online: 3 DEC 2012
- Article first published online: 1 OCT 2012
Small vitiliginous patches have been treated with epidermal grafts or their cell suspensions. In an attempt to overcome some of the shortcomings of cell suspension delivery, we have delivered melanocytes on a polymeric film.
To evaluate the clinical effectiveness of a cultured graft consisting of autologous cultured melanocytes on a poly (dl-lactic acid) (PLA) film in subjects with stable vitiligo.
A prospective open-label, randomized, multicenter clinical trial was conducted with 22 patients. Each subject was treated with cultured graft and polyurethane dressing (control arm) after epidermal ablation and followed for up to 9 months. The extent of repigmentation in the treated sites was compared with that control sites at days 90, 180, and 270.
In the treatment arm, a minimum of 70% repigmentation was observed in five subjects at day 90; nine at day 180, and 10 at day 270. In the control arm, only one subject showed repigmentation until day 270. None of the test sites reported any recurrence of vitiliginous patches by the end of the study.
Cultured melanocytes delivered on PLA film were efficacious and safe when applied on patients with stable vitiligo.