Bone Morphogenetic Proteins (BMPs)
BMPs are naturally occurring growth factors that belong to the transforming growth factor beta (TGF-ß) superfamily of extracellular proteins. Initially discovered in 1965 by Marshal Urist, BMPs are the only known proteins capable of inducing the formation of new bone. BMPs act by binding to the cell’s exterior and signaling to the nucleus via intracellular proteins called SMADs, which in turn induce transcription of numerous osteogenic genes. This mechanism is essential in the formation and repair of a variety of tissue types, including bone.
For over a decade, Stryker has been dedicated to the research and development of BMP-7 (also known as Osteogenic Protein-1 or OP-1) for clinical applications. Like other members of the bone morphogenetic protein family of proteins, BMP-7/OP-1 plays a key role in the transformation of mesenchymal cells into bone. BMP-7/OP-1 actively recruits stem cells from the surrounding tissue and initiates the bone formation cascade.
BMP-7 is found naturally in bone, but only in trace amounts. Extraction of purified human BMP-7 from cadaver bone would yield extremely limited amounts, making it economically unfeasible for clinical use. As a result, Stryker has developed a recombinant biotechnology process to manufacture larger yields of the recombinant version of the naturally occurring BMP-7 (rhBMP-7/OP-1) for clinical use. The manufacturing process of rhBMP-7/OP-1 is carefully controlled, with each lot subject to rigorous testing to ensure consistent structure, purity and osteoinductivity of the protein in the final product. OP-1 is produced and delivered on a purified Type I bone collagen carrier, which provides an osteoconductive scaffold on which the new bone can grow.
rhBMP-7/OP-1 is the active ingredient in OP-1 Putty and OP-1 Implant for spine and trauma indications, respectively. In 2001, the FDA approved OP-1 Implant, making it the first bone morphogenetic protein of its kind to be approved for clinical use in the United States. OP-1 Implant was approved under a Humanitarian Device Exemption (HDE) for use as an alternative to the patient's own bone (autograft) in recalcitrant long bone nonunions where autograft is unfeasible and alternative treatments have failed. In 2004, the FDA approved OP-1 Putty under an HDE for revision posterolateral (intertransverse) lumbar spinal fusions where autograft and bone marrow harvest are not feasible or are not expected to promote fusion due to compromising factors including osteoporosis, smoking and diabetes.