Bone Regeneration Scaffolds

DESCRIPTION (provided by applicant): In 2001, a spinal fusion procedure was performed on average every 2 minutes in the United States at a mean cost of $34,000. Autograft bone from the iliac crest, the "gold standard" bone graft material for this procedure, results in non-union failures in 5% to 35% of procedures with morbidity and pain at the donor site in up to 25% of procedures after 2 years. Recombinant human bone morphogenetic protein 2 (rhBMP-2) has demonstraed some efficacy for spinal fusion applications. However, the limited approval for spinal fusion (anterior procedures with a cage only) and its high cost ($5000-$7000 per procedure) limits its availably for the majority of spinal fusion procedures. Thus, there is a clear need for a bone graft material that improves the fusion success rate and eliminates donor site morbidity. This study is designed to produce a bone implant composite that eliminates the use of autologous bone and maintains or improves current spinal fusion success rates. Encelle's proprietary tissue regenerative cell scaffold, E-Matrx(tm), has demonstrated the ability to heal dermal wounds. In this study E-Matrix will be engineered for use in spinal fusion procedures. Specifically, this study will develop thermally stable, macroporous cell regenerative scaffolds for bone repair; demonstrate in vitro biological activity of these scaffolds by evaluating up- regulation of genes important for bone repair and regeneration (BMP-2, osteocalcin, collagen Ia1, vascular endothelial growth factor, and LMP-1); and demonstrate the ability of the scaffolds to stimulate healing of critical size bone defects in rat calvaria. This research will provide the basis for a new therapeutic alternative for bone regeneration and specifically provide a cost effective approach to improving the outcome of the nearly 450,000 spinal fusion procedures performed each year.