title: Phase I/II clinical evaluation of StrataGraft: a consistent, pathogen-free human skin substitute.
abstract: BACKGROUND
  Large wounds often require temporary allograft placement to optimize the wound bed and prevent infection until permanent closure is feasible. We developed and clinically tested a second-generation living human skin substitute (StrataGraft). StrataGraft provides both a dermis and a fully-stratified, biologically-functional epidermis generated from a pathogen-free, long-lived human keratinocyte progenitor cell line, Neonatal Immortalized KeratinocyteS (NIKS).
  
  
  METHODS
  Histology, electron microscopy, quantitative polymerase chain reaction, and bacterial growth in vitro were used to analyze human skin substitutes generated from primary human keratinocytes or NIKS cells. A phase I/II, National Institute of Health-funded, randomized, safety, and dose escalation trial was performed to assess autograft take in 15 patients 2 weeks after coverage with StrataGraft skin substitute or cryopreserved cadaver allograft.
  
  
  RESULTS
  StrataGraft skin substitute exhibited a fully stratified epidermis with multilamellar lipid sheets and barrier function as well as robust human beta defensin-3 mRNA levels. Analysis of the primary endpoint in the clinical study revealed no differences in autograft take between wound sites pretreated with StrataGraft skin substitute or cadaver allograft. No StrataGraft-related adverse events or serious adverse events were observed.
  
  
  CONCLUSIONS
  The major finding of this phase I/II clinical study is that performance of StrataGraft skin substitute was comparable to cadaver allograft for the temporary management of complex skin defects. StrataGraft skin substitute may also eliminate the risk for disease transmission associated with allograft tissue and offer additional protection to the wound bed through inherent antimicrobial properties. StrataGraft is a pathogen-free human skin substitute that is ideal for the management of severe skin wounds before autografting.
authors.affiliation: Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA. schurr@ surgery.wisc.edu
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Schurr
authors.forename: Kevin N
authors.initials: KN
authors.lastname: Foster
authors.forename: John M
authors.initials: JM
authors.lastname: Centanni
authors.forename: Allen R
authors.initials: AR
authors.lastname: Comer
authors.forename: April
authors.initials: A
authors.lastname: Wicks
authors.forename: Angela L
authors.initials: AL
authors.lastname: Gibson
authors.forename: Christina L
authors.initials: CL
authors.lastname: Thomas-Virnig
authors.forename: Sandy J
authors.initials: SJ
authors.lastname: Schlosser
authors.forename: Lee D
authors.initials: LD
authors.lastname: Faucher
authors.forename: Mary A
authors.initials: MA
authors.lastname: Lokuta
authors.forename: B Lynn
authors.initials: BL
authors.lastname: Allen-Hoffmann
mesh_terms: D000328:Adult; D002102:Cadaver; D003646:Debridement; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016038:Skin Transplantation; D017768:Skin, Artificial / Q000382:microbiology; D017695:Soft Tissue Injuries / Q000601:surgery*; D013210:Staphylococcus; D014945:Wound Healing / Q000502:physiology*