Glowacki Julie
Department of Orthopedic Surgery, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.
Cell Tissue Bank. 2005;6(1):3-12. doi: 10.1007/s10561-005-4252-z.
Allogeneic demineralized bone has been used extensively as a clinical graft material because it has osteoinductive and osteoconductive properties. Concerns over processing and terminal sterilization procedures that may reduce performance have led clinicians to call for assurances of product potency. There is extensive experience on effects of demineralized bone in animal and cell culture models with the possibility for future evidence-based standards for release of products. Evaluation of the current state of knowledge leads to the fact that we cannot conclude that performance of different lots of demineralized bone allografts in in vivo or in vitro test systems can be used as a measure of clinical performance. It may be possible to adopt an osteoinductivity standard for release-to-market, but it should be followed by clinical monitoring and further research.
同种异体脱矿骨因其具有骨诱导性和骨传导性，已被广泛用作临床移植材料。对可能降低其性能的加工和最终灭菌程序的担忧，促使临床医生要求确保产品效力。在动物和细胞培养模型中，对于脱矿骨的作用已有广泛研究，未来有可能制定基于证据的产品放行标准。对当前知识状态的评估表明，我们不能得出结论，即不同批次的脱矿骨同种异体移植物在体内或体外测试系统中的性能可作为临床性能的衡量标准。有可能采用骨诱导性标准来批准产品上市，但随后应进行临床监测和进一步研究。
