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.
Riedel
G E
GE
Genetics Institute Inc, Cambridge, Mass 02140, USA.
Valentin-Opran
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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