Clinical Evaluation of NIKS-Based Bioengineered Skin Substitute Tissue in Complex Skin Defects: Phase I/IIa Clinical Trial Results

Background: Complex skin defects, such as burns and acute cutaneous trauma, are life-threatening injuries, often requiring temporary allograft placement to maintain fluid homeostasis and prevent infection until permanent wound closure is possible. The Problem: The current standard of care for the management of full-thickness wounds that are unable to be closed in a single surgical stage is temporary coverage with cadaver allograft until an acceptable wound bed has been established. This approach has limitations including limited availability of human cadaver skin, the risk of disease transmission from cadaveric grafts, and inconsistent cadaver allograft quality. Basic/Clinical Science: Near-diploid neonatal human keratinocyte cell line (NIKS)-based human skin tissue is a full-thickness, living human skin substitute composed of a dermal analog containing normal human dermal fibroblasts and a fully-stratified, biologically and metabolically active epidermis generated from NIKS keratinocytes, a consistent an...