초록 ▼

Disclosed are terminally sterilized osteogenic devices for implantation into a mammal. The devices contain a combination of a biologically active osteogenic protein and an insoluble carrier which after being combined are sterilized by exposure to ionizing radiation, for example, by exposure to gamma

Disclosed are terminally sterilized osteogenic devices for implantation into a mammal. The devices contain a combination of a biologically active osteogenic protein and an insoluble carrier which after being combined are sterilized by exposure to ionizing radiation, for example, by exposure to gamma rays or an electron beam. The terminally sterilized devices of the invention are characterized in that they induce bone formation following implantation into a mammal. Also disclosed is a method for inducing bone formation in a mammal by implanting a terminally sterilized device of the invention into a preselected locus in a mammal. Also disclosed is a method for preparing the terminally sterilized device of the invention.

대표청구항 ▼

[ What is claimed is:] [1.] A method of inducing endochondral bone formation or articular cartilage formation in a mammal, the method comprising the steps of:(a) implanting at a preselected locus in the mammal, a terminally sterilized osteogenic device produced by the steps of:(i) providing an osteo

[ What is claimed is:] [1.] A method of inducing endochondral bone formation or articular cartilage formation in a mammal, the method comprising the steps of:(a) implanting at a preselected locus in the mammal, a terminally sterilized osteogenic device produced by the steps of:(i) providing an osteogenic device comprising in combinationa biocompatible, biodegradable insoluble carrier comprising a natural or synthetic polymeric material and dimensioned to permit infiltration, proliferation, and differentiation of migratory progenitor cells when implanted into the mammal, and disposed therein,an isolated, biologically active osteogenic protein comprising a pair of disulfide bonded polypeptide chains which is competent to induce endochondral bone formation or articular cartilage formation when disposed in the carrier and implanted into the mammal, and(ii) exposing the osteogenic device of step (i) to ionizing radiation in an amount sufficient to achieve a sterility assurance factor of 10.sup.-6 thereby to produce a terminally sterilized osteogenic device which is competent to induce endochondral bone formation or articular cartilage formation in the mammal; and(b) permitting the terminally sterilized osteogenic device to induce endochondral bone formation or articular cartilage formation at the preselected locus.