ENHANCEMENT OF LUMBAR FUSION W/ RHBMP 2/ COLLAGEN OR LMP

使用 RHBMP 2/胶原蛋白或 LMP 增强腰椎融合

• 批准号: 7958099
• 负责人: SCOTT D. BODEN
• 金额: $ 4.39万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-05-01 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7958099
• 关键词: Animals; Ceramics; Clinical Trials; Collagen; Complication; Computer Retrieval of Information on Scientific Projects Database; Cytoplasmic Granules; Dose; Failure; Funding; Genetic Engineering; Grant; Growth Factor; Healed; Human; Implant; Institution; Modeling; Monkeys; Oryctolagus cuniculus; Osteogenesis; Paste substance; Preparation; Primates; Recombinants; Reporting; Research; Research Personnel; Resistance; Resources; Site; Source; Speed; Spinal Fusion; Testing; Titanium; United States National Institutes of Health; Vertebral column; Work; bone; bone morphogenetic protein 2; follow-up; healing; minimally invasive; nonhuman primate

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Lumbar spinal fusion is commonly performed in humans, but the failure of bone union is a frequent complication. Osteoinductive growth factors synthesized by recombinant DNA technology have been shown to induce bone formation in heterotopic sites. Recombinant human BMP-2 (rhBMP-2) has been effective in generating spine fusions in a rabbit model. To determine the dose of the growth factor in humans and to determine the speed of healing, a non-human primate model is used. Higher doses than expected were required to make bone in the primate. The growth factor was delivered inside a hollow titanium threaded fusion cage through a minimally invasive approach. This work resulted in the initiation of a human pilot clinical trial with excellent results at one year follow up. Studies have focused on fine tuning the dose and studying alternative carrier materials including different combinations of ceramic materials for use in the posterolateral spine. We investigated new carriers for BMP-2 and continued studies with LMP-1, and we found that a compression resistant collagen matrix was an effective carrier, and this will move on to human trials. Monkeys were implanted with rhBMP-2 with a slower release carrier (paste form), and these results demonstrated that the paste was not as effective as previous carriers. During the reporting period, we tested wrapping the existing BMP-2 preparation around a ceramic granule matrix as a bulking agent. This was successful in 2/3 animals to achieve spine fusion.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 腰椎融合术在人类中很常见，但骨愈合失败是一种常见的并发症。通过重组DNA技术合成的骨诱导生长因子已被证明可以诱导异位点的骨形成。 重组人 BMP-2 (rhBMP-2) 已在兔子模型中有效地产生脊柱融合。 为了确定人类生长因子的剂量并确定愈合速度，使用了非人类灵长类动物模型。灵长类动物的骨骼生长需要比预期更高的剂量。 通过微创方法将生长因子输送到空心钛螺纹融合笼内。 这项工作导致启动了一项人体试点临床试验，并在一年的随访中取得了优异的结果。研究重点是微调剂量并研究替代载体材料，包括用于后外侧脊柱的陶瓷材料的不同组合。 我们研究了 BMP-2 的新载体，并继续研究 LMP-1，我们发现抗压胶原蛋白基质是一种有效的载体，这将继续进行人体试验。 猴子被植入带有较慢释放载体（糊剂形式）的 rhBMP-2，这些结果表明糊剂不如以前的载体有效。 在报告期内，我们测试了将现有的 BMP-2 制剂包裹在陶瓷颗粒基质上作为填充剂。 这在 2/3 的动物身上成功实现了脊柱融合。