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FDA-approved bone grafts and bone graft substitute devices in bone regeneration

机译:FDA批准的骨移植物和骨移植件骨再生替代装置

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摘要

To induce bone regeneration there is a complex cascade of growth factors. Growth factors such as recombinant BMP-2, BMP-7, and PDGF are FDA-approved therapies in bone regeneration. Although, BMP shows promising results as being an alternative to autograft, it also has its own downfalls. BMP-2 has many adverse effects such as inflammatory complications such as massive soft-tissue swelling that can compromise a patient's airway, ectopic bone formation, and tumor formation. BMP-2 may also be advantageous for patients not willing to give up smoking as it shows bone regeneration success with smokers. BMP-7 is no longer an option for bone regeneration as it has withdrawn off the market. PDGF-BB grafts in studies have shown PDGF had similar fusion rates to autologous grafts and fewer adverse effects. There is also an FDA-approved bioactive molecule for bone regeneration, a peptide P-15. P-15 was found to be effective, safe, and have similar outcomes to autograft at 2 years post-op for cervical radiculopathy due to cervical degenerative disc disease. Growth factors and bioactive molecules show some promising results in bone regeneration, although more research is needed to avoid their adverse effects and learn about the long-term effects of these therapies. There is a need of a bone regeneration method of similar quality of an autograft that is osteoconductive, osteoinductive, and osteogenic. This review covers all FDA-approved bone regeneration therapies such as the "gold standard" autografts, allografts, synthetic bone grafts, and the newer growth factors/bioactive molecules. It also covers international bone grafts not yet approved in the United States and upcoming technologies in bone grafts.
机译:为了诱导骨再生,存在复杂的生长因子级联。重组BMP-2,BMP-7和PDGF等生长因子是FDA批准的骨再生疗法。虽然,BMP显示有希望的结果作为自动移植的替代方案,它也有自己的垮台。 BMP-2具有许多不良反应,例如炎症并发症,例如巨大的软组织肿胀,可以损害患者的气道,异位骨形成和肿瘤形成。 BMP-2也可能对患者不愿意吸烟,因为它显示出骨再生与吸烟者的成功。 BMP-7不再是骨再生的选择,因为它已退出市场。研究中的PDGF-BB移植物已显示PDGF与自体移植物相似的融合率和更少的不良反应。还有一种用于骨再生的FDA批准的生物活性分子,肽P-15。发现P-15有效,安全,并且由于宫颈退行性椎间盘疾病而在宫颈隐性疗法的2年后对自体移植的成果。生长因子和生物活性分子表明一些有希望的骨再生导致骨再生导致耐骨再生导致避免其不利影响,并了解这些疗法的长期影响。需要一种类似的自体性质量的骨再生方法,其是骨导电,骨诱导和成骨的。本综述涵盖了所有FDA批准的骨再生疗法,例如“金标准”自体移植物,同种异体移植物,合成骨移植物和新的生长因子/生物活性分子。它还涵盖了美国尚未在美国尚未批准的国际骨移植以及骨移植中即将到来的技术。

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