ENHANCEMENT OF LUMBAR FUSION W/ RHBMP 2/COLLAGEN

使用 RHBMP 2/胶原蛋白增强腰椎融合

• 批准号: 6277478
• 负责人: SCOTT D BODEN
• 金额: $ 3.36万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-05-01 至 1999-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6277478
• 关键词: Mammalia; Primates; animal tissue; biological products; prosthesis; skeletal system; structural biology; transplantation

Lumbar spinal fusion is commonly performed in humans but the failure rate of bone union is reported to range from 5-36%. Recently, 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 appropriate dose of the growth factor for human use and to determine the speed of healing, a non-human primate model has been chosen. Higher doses than expected were required to make bone in the primate, but it was successful. The growth factor was successfully delivered inside a hollow titanium threaded fusion cage through a minimally invasive approach. Studies in 1997 focused on fine tuning the necessary dose and studying alternative carrier materials for the growth factor including different combinations of ceramic materials. Studies in 1998 will focus on continuing to explore alternat ive carrier materials that will better bind the growth factor and still be resorbable. These studies are critical to providing the information needed for the next step which is human clinical trials. This treatment, if successful, will significantly impact on the care of spine patients and prevent multiple surgeries in the 5-35% of patients who do not heal their spine fusion on the first attempt.

腰椎融合术通常在人类中进行，但 据报道，骨愈合的失败率范围为5- 36%。 最近， 重组DNA合成骨诱导生长因子 技术已经显示在异位中诱导骨形成 网站. 重组人骨形态发生蛋白-2（rhBMP-2）已有效地 在兔子模型中产生脊柱融合。 确定 人类使用的生长因子的适当剂量，并确定 治愈的速度，一个非人类的灵长类动物模型已经被选中。 灵长类动物需要比预期更高的剂量才能生成骨骼， 但很成功 成长因子成功交付 在一个中空的钛螺纹融合器内， 侵入性方法。 1997年的研究重点是微调 必要剂量和研究替代载体材料 生长因子包括陶瓷材料的不同组合。 1998年的研究将集中于继续探索 载体材料将更好地结合生长因子， 可再吸收。 这些研究对于提供信息至关重要 这是下一步人体临床试验所需要的。 这 如果治疗成功，将对治疗产生重大影响。 避免5-35%的患者接受多次手术 第一次尝试就无法治愈脊柱融合