Integration and persistence of an investigational human living skin equivalent (ICX-SKN) in human surgical wounds

摘要

Aim: To present the first human clinical data on an investigational living skin graftnreplacement that is being designed for application where tissue has been lost throughnsurgery, disease or trauma. Materials & Methods: The ICX-SKN skin graft replacement isncomposed of an autosynthesized human collagen-based extracellular matrix and humanndermal fibroblasts. In a first study to examine integration and persistence, full-thicknessnexcisional wounds were made in six healthy human female volunteers and the ICX-SKN skinngraft replacement applied and dressed. The surgical wounds were examined for up to 28ndays post-application and the graft excised from each volunteer. Results: Pre-excisionngross examination revealed that the ICX-SKN skin graft replacement had integrated well inneach of the six wounds and that re-epithelialization had occurred in each case. Histologicalnanalysis revealed that the ICX-SKN skin graft replacement remained in place and hadnbecome vascularized and provided a continuous wound closure. No serious adverse eventsnwere reported and no gross scarring or wound contracture was evident in the healednwounds. Conclusion: This is the first report of preliminary evidence indicating thenpersistence of an autosynthesized, tissue-engineered, living human skin substitute innhealed acute wounds in humans.