Local sustained delivery of recombinant human bone morphogenetic protein-2 (rhBMP-2)

Local delivery of recombinant human bone morphogenetic protein-2 (rhBMP-2) as a bone graft substitute in spinal fusion was Food and Drug Administration approved on July 2, 2002. Its commercial trade name is INFUSE Bone Graft. It was cleared as a combination biologic device after petitioning the FDA in the early 1990s with the argument that rhBMP-2's effects were only local and not systemic. The protein is applied to a type I collagen sponge at the time of surgery. After a minimum of 15 minutes to allow binding, the collagen sponge is rolled up and placed into a titanium spinal fusion cage. Two of the rhBMP-2 loaded cages are implanted into an intervertebral spinal disc space to promote bone growth across the disc, i.e., spinal fusion. Fusion stops motion at the treated level and ultimately reduces back pain originating from the degenerated disc. This same product was FDA approved for a tibia long bone fresh fracture bone grafting application in August 2004, and for sinus elevation and alveolar defects associated with extraction sockets in March 2007. In addition, a new carrier is under clinical evaluation that will offer longer rhBMP-2 sustained release and compression resistance, further expanding the clinical utility of rhBMP-2.