An autologous epidermal equivalent tissue-engineered from follicular outer root sheath keratinocytes is as effective as split-thickness skin autograft in recalcitrant vascular leg ulcers

Wound Repair Regen. Jul-Aug 2003;11(4):248-52. doi: 10.1046/j.1524-475x.2003.11403.x.


The outer root sheath of hair follicles plays an important role in epidermal regeneration in vivo. Keratinocytes isolated by explantation of outer root sheath tissue have extensive proliferative capacity irrespective of donor age, which probably depends on pluripotent epithelial stem cells residing in the outer root sheath. These keratinocytes can be organotypically grown to epidermal equivalents in vitro. We report here that in a multicenter, randomized phase II study, EpiDex trade mark, a tissue-engineered, fully differentiated autologous epidermal equivalent derived from keratinocytes of the outer root sheath of plucked anagen hair follicles, is as effective as split-thickness skin autografting in the promotion of healing and complete closure of recalcitrant vascular leg ulcers.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Female
  • Hair Follicle / cytology
  • Hair Follicle / transplantation*
  • Humans
  • Keratinocytes / cytology
  • Keratinocytes / transplantation*
  • Leg Ulcer / etiology
  • Leg Ulcer / prevention & control*
  • Leg Ulcer / surgery
  • Male
  • Middle Aged
  • Prospective Studies
  • Secondary Prevention
  • Skin Transplantation / methods*
  • Surgical Mesh*
  • Tissue Engineering / methods*
  • Vascular Diseases / complications