Bioactive Peptide Coatings for Synthetic Bone Grafts

用于合成骨移植物的生物活性肽涂层

• 批准号: 8500392
• 负责人: JONATHAN A HODGES
• 金额: $ 90.01万
• 依托单位: AFFINERGY, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8500392
• 关键词: Adverse effects; Aftercare; Animals; Arthrodesis; Aspirate substance; Autologous Transplantation; Back Pain; Binding; Bone Marrow; Bone Transplantation; Ceramics; Clinical; Data; Defect; Dental; Dose; Drug Formulations; Experimental Models; Extravasation; Frequencies; Goals; Gold; Growth Factor; Harvest; Healed; Hemorrhage; Histology; Hydration status; Inferior; Inflammation; Liquid substance; Marketing; Mechanics; Medical Device; Modeling; Morbidity - disease rate; Operative Surgical Procedures; Oryctolagus cuniculus; Osteogenesis; Outcome; Patients; Peptides; Phase; Physicians; Process; Pseudarthrosis; Rattus; Recombinants; Research; Risk; Safety; Secure; Sheep; Site; Spinal; Spinal Fusion; Staging; Surgeon; Surgical sutures; Testing; Therapeutic; Time; Treatment Cost; United States; Vertebral column; Visit; X-Ray Computed Tomography; bone; bone morphogenetic protein 2; cost; cost effective; effective therapy; efficacy testing; flexibility; healing; implantation; improved; long bone; meetings; osteoinductive factor; osteosarcoma; physical property; recombinant human bone morphogenetic protein-2; research study; success

DESCRIPTION (provided by applicant): Back pain is one of the leading reasons for physician visits in the United States and in many cases requires surgical intervention. In the United States, there are over 500,000 spinal fusion surgeries every year, and the frequency of these surgeries is projected to grow 6% per year. The gold standard for bone graft in spinal fusion is autograft from the iliac crest; however, the use of autograft presents multiple challenges including donor site morbidity, blood loss, limited availability, prolonged operating times, and pseudarthrosis due to a slow rate of fusion. As a result, there is a large effort to develop bone graft substitutes or extenders that can not only reduce or replace the need for harvest of autogenous bone but also accelerate the rate of fusion (arthrodesis). Ceramic bone graft substitutes provide osteoconductive and bioresorbable bone graft substitutes but have shown poor results when used as stand-alone treatments. Bone marrow aspirate contains osteoinductive factors, but the current carriers are not adequate for the retention and release of these osteoinductive factors over a prolonged period of time. Therefore, there is an unmet clinical need in spinal fusion surgery for a safe, cost-effective bone graft substitute that can maintain a sustained dose of osteoinductive factors throughout the early stages of the healing process. We have developed a bone graft substitute that can capture and retain osteoinductive growth factors and propose to test its ability to improve the fusion rate in spinal fusion surgery.

描述（由申请人提供）：背部疼痛是美国医生就诊的主要原因之一，在许多情况下需要手术干预。在美国，每年有超过50万例脊柱融合手术，这些手术的频率预计每年增长6%。脊柱融合术中植骨的金标准是自体髂骨；然而，自体移植物的使用面临多重挑战，包括供体部位发病率、失血、可用性有限、手术时间延长以及由于融合速度缓慢而导致的假关节。因此，人们正在努力开发骨移植替代物或扩展物，不仅可以减少或替代自体骨的采集需求，还可以加快融合（关节融合术）的速度。陶瓷骨移植替代物提供骨导电性和生物可吸收性骨移植替代物，但作为单独治疗时效果不佳。骨髓抽吸液含有骨诱导因子，但目前的载体不足以使这些骨诱导因子在较长时间内保持和释放。因此，在脊柱融合手术中，需要一种安全、经济的骨移植物替代品，能够在愈合过程的早期阶段维持持续剂量的骨诱导因子，这是尚未满足的临床需求。我们已经开发了一种骨移植替代物，可以捕获和保留骨诱导生长因子，并建议测试其在脊柱融合手术中提高融合率的能力。