Clinical evaluation of rhBMP-2/ACS in orthopedic trauma: A progress report

Recombinant human bone morphogenetic protein-2 (rhBMP-2) is an osteoinducti ve protein that plays a pivotal role in bone growth and regeneration. Studi es conducted in many mammalian species and, most recently, human clinical s tudies, have provided definitive evidence of the ability of rhBMP-2 to indu ce bone. The findings of these studies provide a rationale for investigatin g whether rhBMP-2 therapy will be clinically useful in orthopedic practice. Consequently, we have initiated a clinical research program to evaluate th e safety and efficacy of rhBMP-2 therapy in open tibial fractures. A prospe ctive observational study (involving no rhBMP-2 treatment) was conducted to define an appropriate patient population for rhBMP-2 clinical trials and h as provided critical information related to the design and execution of fut ure studies. The rhBMP-2 clinical trials include a small pilot feasibility study and several larger studies. Data from the pilot feasibility study hav e demonstrated that implantation of rhBMP-2 (combined with an absorbable co llagen sponge) is surgically feasible and safe. Larger, multicenter clinica l studies are now ongoing in the United States and abroad.