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

Abstract

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