EpiDex®, follicular keratinocyte sheets for treatment of chronic wounds

EpiDex® is an epidermis-equivalent sheet, tissue-engineered from autologous outer root sheath (ORS) keratinocytes, indicated for treatment of chronic wounds. Epidermal keratinocyte precursor cells are isolated from the follicular ORS of a patient’s plucked anagen head hairs. Cells are expanded in culture and allowed to differentiate in EpiDex® discs into a tissue that resembles the multilayered structure of the human epidermis. A phase II clinical trial was performed in order to evaluate the safety and efficacy of EpiDex® treatment compared to standard skin autografts. The study showed that autologous epidermis equivalents can be as safe and effective as split-thickness skin autografts in treating chronic vascular leg ulcers. The 4-year follow-up demonstrated that 74% of the patients had complete wound healing and 78% reported complete disappearance of wound-associated pain following EpiDex® treatment.