Spatiotemporally Controlled Keratin Biomaterial Delivery System for Functional Tissue Regeneration

Currently, no commercial products exist for the repair of large injuries to muscle, particularly volumetric muscle loss (VML). In Phase I of this project, data demonstrated that keratin biomaterials can provide temporal release of growth factors while maintaining cell viability in vitro and in vivo. In Phase II, the biomaterial formulation was optimized for spatio-temporal delivery of cells and growth factors. In evaluating the efficacy of a variety of formulations, keratin hydrogels alone demonstrated statistically significant improvements in functional outcomes over those observed in injuries left unrepaired or repaired with bladder acellular matrix (BAM). In a 20-30% rat tibialis anterior defect VML injury, treatment with keratin hydrogels achieved approximately 90% of the maximal possible functional recovery possible. This Phase II effort seeks to complete the pre-clinical work necessary for an Investigative Device Exemption, including final development work and ISO 10993 testing, and execute a 5 patient human clinical trial. The trial will examine safety for repair of VML of the anterior compartment associated with a high-energy open tibia fracture Type II-IIIA.