Abstract
Alpha-BSM® is a biomimetic endothermically setting apatitic calcium phosphate bone substitute material. Its injectability and ability to harden at body temperature in the presence of physiologic saline, and other buffering agents, makes it an attractive clinical bone substitute and delivery vehicle for therapeutic agents in orthopaedic and dental applications. In osseous tissue, alpha-BSM® alone remodels into bone and promotes bone healing. Alpha-BSM® treatment has been shown in several animal models to be effective in promoting healing of surgically created critical size defects and restoring bone biomechanical strength to values equal to or greater than values achieved with autograft controls. In vitro studies with alpha-BSM® containing gentamicin show that antibiotics can be incorporated stably into alpha-BSM® and that the release kinetics can be controlled with the appropriate formulation and preparative procedures. Growth factors and enzymes also are compatible with the alpha-BSM® setting reaction. The incorporation of recombinant human bone morphogenetic protein-2 with alpha-BSM® was shown to be effective in stimulating bone formation and accelerating restoration of the differentiated phenotype in an osteotomy model. Clinical trial investigators in Europe currently are using alpha-BSM® implantations for treatment of fractures and other indications.