Preclinical and clinical evaluation of osteogenic protein-1 (BMP-7) in bony sites

Osteogenic proteins (OPs), also referred to as bone morphogenetic proteins (BMPs), are a family of bone-matrix polypeptides isolated from a variety of mammalian species. Implantation of osteogenic proteins induces a sequence of cellular events that leads to the formation of new bone. In preclinical studies, the implantation of recombinantly produced human osteogenic protei n-1 (OP-1, also referred to as BMP-7) into surgically created, critical-siz e diaphyseal segmental defects resulted in the regeneration of new bone tha t was fully functional biologically and biomechanically. Injection of an OP -1 solution into a fresh fracture model accelerated the bone repair process compared with control fracture healing. This was the result of greater and earlier new bone formation. Further study has demonstrated that OP-1 can b e used as a bone graft substitute to promote spinal fusion, aid in the inco rporation of metal implants, and improve the performance of autograft and a llograft bone. Clinical study of OP-1 implanted in conjunction with a bovine bone-derived type 1 collagen carrier for the treatment of tibial nonunion fractures has shown healing characteristics similar to that obtained with autogenous ilia c crest bone graft. Advantages of OP-1 included no donor site complications , less blood loss, and a shorter operative time.