Phase I/II Clinical Evaluation of StrataGraft: A Consistent, Pathogen-Free Human Skin Substitute

• DOI: 10.1097/ta.0b013e31819849d6
• Publication Date: 2009-05-21T19:43:51Z
• Authors: Michael J. Schurr; Kevin N. Foster; John M. Centanni; Allen R. Comer; April Wicks; Angela L. Gibson; Christina L. Thom...; Sandy J. Schlosser; Lee D. Faucher; Mary A. Lokuta; B Lynn Allen-Hoff...
• Keywords: Human skin; Epidermis (zoology); Barrier function; Erythema

Background: Large wounds often require temporary allograft placement to optimize the wound bed and prevent infection until permanent closure is feasible. We developed clinically tested a second-generation living human skin substitute (StrataGraft). StrataGraft provides both dermis fully-stratified, biologically-functional epidermis generated from pathogen-free, long-lived keratinocyte progenitor cell line, Neonatal Immortalized KeratinocyteS (NIKS). Methods: Histology, electron microscopy, quantitative polymerase chain reaction, bacterial growth in vitro were used analyze substitutes primary keratinocytes or NIKS cells. A phase I/II, National Institute of Health-funded, randomized, safety, dose escalation trial was performed assess autograft take 15 patients 2 weeks after coverage with cryopreserved cadaver allograft. Results: exhibited fully stratified multilamellar lipid sheets barrier function as well robust β defensin-3 mRNA levels. Analysis endpoint clinical study revealed no differences between sites pretreated No StrataGraft-related adverse events serious observed. Conclusions: The major finding this I/II that performance comparable for management complex defects. may also eliminate risk disease transmission associated tissue offer additional protection through inherent antimicrobial properties. pathogen-free ideal severe before autografting.