![]() This study examined the efficacy and safety of bone graft material ABM/P-15 (iFACTOR) for use in posterior lumbar interbody fusion. It also covers international bone grafts not yet approved in the United States and upcoming technologies in bone grafts. This review covers all FDA-approved bone regeneration therapies such as the “gold standard” autografts, allografts, synthetic bone grafts, and the newer growth factors/bioactive molecules. There is a need of a bone regeneration method of similar quality of an autograft that is osteoconductive, osteoinductive, and osteogenic. Growth factors and bioactive molecules show some promising results in bone regeneration, although more research is needed to avoid their adverse effects and learn about the long-term effects of these therapies. P-15 was found to be effective, safe, and have similar outcomes to autograft at 2 years post-op for cervical radiculopathy due to cervical degenerative disc disease. There is also an FDA-approved bioactive molecule for bone regeneration, a peptide P-15. ![]() PDGF-BB grafts in studies have shown PDGF had similar fusion rates to autologous grafts and fewer adverse effects. BMP-7 is no longer an option for bone regeneration as it has withdrawn off the market. BMP-2 may also be advantageous for patients not willing to give up smoking as it shows bone regeneration success with smokers. BMP-2 has many adverse effects such as inflammatory complications such as massive soft-tissue swelling that can compromise a patient’s airway, ectopic bone formation, and tumor formation. Although, BMP shows promising results as being an alternative to autograft, it also has its own downfalls. ![]() Growth factors such as recombinant BMP-2, BMP-7, and PDGF are FDA-approved therapies in bone regeneration. To induce bone regeneration there is a complex cascade of growth factors. This chapter will discuss these products along with their supporting clinical data. The OP-1 Implant (rhBMP-7) was marketed for a period of time, but it has been removed from the market. the other technologies, which are autograft extenders. ![]() Both of these products have been shown to be effective autograft replacement options, vs. Currently, there are only two PMA-supported Class III drug-device bone graft substitutes with Level I data that demonstrate equivalence to autograft for safety and effectiveness in spine: Infuse® (rhBMP-2) and i-FACTOR (P-15 peptide). Drug-device combination bone grafts are Class III and require an investigational device exemption (IDE) clinical trial followed by a premarket approval (PMA) application with the FDA to review safety and effectiveness. Synthetic bone grafts and demineralized bone matrices (DBMs) fall under Class II and require a 510(k) for market clearance, generally on the basis of an animal study. Nonstructural allograft and cellular allograft products that do not rely on the metabolic activity of living cells are HCT/P products, which require no premarket review for safety and efficacy.
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