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: 8200327
• 负责人: JONATHAN A HODGES
• 金额: $ 77.69万
• 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 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8200327
• 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. PUBLIC HEALTH RELEVANCE: Spinal fusion surgery is an effective treatment for back pain but carries multiple risks. We have developed a medical device that can improve the formation of new bone and reduce the risks found with other products. We propose to test our product in a model of spinal fusion.

描述（由申请人提供）：背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髂嵴自体植骨;然而，使用自体植骨存在多种挑战，包括供体部位发病、失血、可用性有限、手术时间延长以及由于融合速度慢而导致的假关节。因此，人们付出了很大的努力来开发骨移植替代物或扩展物，其不仅可以减少或取代对自体骨的收获的需要，而且还可以加速融合（关节固定术）的速率。陶瓷骨移植替代品提供骨传导性和生物可吸收性骨移植替代品，但作为独立治疗使用时效果不佳。骨髓穿刺液含有骨诱导因子，但目前的载体不足以在长时间内保留和释放这些骨诱导因子。因此，在脊柱融合手术中，对于安全、经济有效的骨移植替代物存在未满足的临床需求，所述骨移植替代物可以在愈合过程的整个早期阶段维持持续剂量的骨诱导因子。我们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。 公共卫生相关性：脊柱融合手术是治疗背痛的有效方法，但存在多种风险。我们开发了一种医疗器械，可以改善新骨的形成，并降低其他产品的风险。我们建议在脊柱融合模型中测试我们的产品。