Clinical evaluation of rhBMP-2/ACS in orthopedic trauma: a progress report.
Recombinant human bone morphogenetic protein-2 (rhBMP-2) is an osteoinductive protein that plays a pivotal role in bone growth and regeneration. Studies conducted in many mammalian species and, most recently, human clinical studies, have provided definitive evidence of the ability of rhBMP-2 to induce bone. The findings of these studies provide a rationale for investigating whether rhBMP-2 therapy will be clinically useful in orthopedic practice. Consequently, we have initiated a clinical research program to evaluate the safety and efficacy of rhBMP-2 therapy in open tibial fractures. A prospective observational study (involving no rhBMP-2 treatment) was conducted to define an appropriate patient population for rhBMP-2 clinical trials and has provided critical information related to the design and execution of future studies. The rhBMP-2 clinical trials include a small pilot feasibility study and several larger studies. Data from the pilot feasibility study have demonstrated that implantation of rhBMP-2 (combined with an absorbable collagen sponge) is surgically feasible and safe. Larger, multicenter clinical studies are now ongoing in the United States and abroad.
Genetics Institute Inc, Cambridge, Mass 02140, USA.
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Riedel
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Valentin-Opran
D000063:Accidents, Traffic; D000328:Adult; D000368:Aged; D019485:Bone Morphogenetic Proteins / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D005069:Evaluation Studies as Topic; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D005593:Fracture Fixation, Internal / Q000379:methods; D017102:Fracture Healing / Q000187:drug effects* / Q000502:physiology; D005597:Fractures, Open / Q000188:drug therapy* / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011994:Recombinant Proteins; D013978:Tibial Fractures / Q000188:drug therapy* / Q000601:surgery; D016896:Treatment Outcome
D019485:Bone Morphogenetic Proteins; D011994:Recombinant Proteins