Keratin Biomaterials for Cranio-facial Tissue Engineering

The majority of personnel injured in OIF/OEF have suffered blast injuries from IEDs. Blasts often cause cranio-facial trauma that is difficult to repair surgically. The current standard of care involves the placement of fixation devices and off label use of growth factor carriers. These strategies often require multiple surgical interventions creating a significant need for better technologies that can be used in minimally invasive procedures. A family of biomaterials derived from keratin proteins may provide a platform on which new strategies can be built. Keratins have broad biocompatibility and can be formulated as films, fibers, foams, solid tissue constructs and important to this project, hydrogels. One of the problems with many synthetic and naturally derived biomaterials is that they do not promote cell adhesion and migration into scaffolds that have weak cell-matrix interactions. Keratins have intrinsic cell-binding properties that can be exploited to offer new solutions to cranio-facial regeneration. This Phase II proposal seeks to expand on Phase I data by testing an injectable keratin growth factor carrier in both large and small animal models of mandible defects. The results will be used in an application to the FDA to begin clinical trials for injuries of cranio-facial bone structures.