主权项 |
1. A method of making a bone graft material having osteoinductive and osteoconductive properties for treating osseous defects and neogenesis of bone, which bone graft material is a composite of a biodegradable polymer and granules of beta-tricalciumphosphate, the method comprising the steps of:
providing an osteoinductive mixture, which is a dispersion or solution of:
an organic compound having at least one nitrogen-containing basic group, wherein the organic compound is a plasticizer that can form a salt with an acidic protein having a pKI of 4.0, anda physiologically effective amount of underglycosylated recombinant human BSP obtained under non-denaturing conditions, where the underglycosylated recombinant human BSP is present in said osteoinductive mixture as a salt or complex which has reduced affinity for calcium, hydroxyapatite and complement factor H than regular human BSP present in human serum, and, optionally, a pharmaceutically acceptable excipient or carrier; providing an osteoconductive mixture on the basis of granules of tricalcium diphosphate (Ca3(PO4)2) in beta crystal form, which granules are coated with a biodegradable polymer or co-polymer and, optionally, a pharmaceutically acceptable excipient or carrier, which osteoconductive mixture is moldable and shapable and rapidly hardening in situ when placed by surgery or prosthetic dentistry, and combining said osteoinductive and osteoconductive mixture shortly before or during placement to obtain a bone graft material which furthers osseous repair and the healing of damage or diseased tissues and lesions. |