ENHANCEMENT OF LUMBAR SPINE FUSION W/ BONE MORPHOGENETIC PROTEIN (BMP)

使用骨形态发生蛋白 (BMP) 增强腰椎融合

• 批准号: 6247352
• 负责人: SCOTT D BODEN
• 金额: $ 7.55万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-05-01 至 1998-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6247352
• 关键词: Mammalia; Primates; animal tissue; biological products; drug screening /evaluation; prosthesis; skeletal system; surgery; 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 isolated from bovine long bones have been shown to induce bone formation in heterotopic sites. A bovine derived bone protein (BP) 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. Twenty-six rhesus monkeys underwent lumbar spine fusion and implantation of the BP extract delivered in a carrier of demineralized bone particles or autogenous bone graft (controls) in 1994. The animals tolerated the surgical procedure well and preliminary results indicate that the protein will form bone in a higher animal. The required dose of osteoinductive bone protein was higher than that seen in smaller animals. The animals implanted in 1995 showed that the bo ne formation was more reliable at the higher doses. Studies in the upcoming year will be aimed at finalizing the required dose for human clinical trials, trying a new form of the growth factor that has a putty consistency and trying new carrier materials to deliver the growth factor. 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. P51RR00165-36 1/1/1996 - 12/31/1996 Yerkes Regional Primate Research Center

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， 从牛长骨中分离的骨诱导生长因子 已显示在异位部位诱导骨形成。 牛 衍生的骨蛋白（BP）在生成脊柱 在兔子模型中进行融合。 为了确定合适的剂量， 人类使用的生长因子，并确定愈合的速度， 选择了非人灵长类动物模型。 26只恒河猴 接受腰椎融合术并植入BP浸提液 在脱矿质骨颗粒的载体中递送或自体的 1994年进行骨移植（对照）。 动物们能忍受手术 程序良好，初步结果表明，蛋白质将 在高等动物中形成骨头。 所需的骨诱导剂量 骨蛋白比在较小动物中观察到的要高。 的 1995年植入的动物表明， 在高剂量下可靠。 明年的研究将是 旨在最终确定人体临床试验所需的剂量， 尝试一种新形式的生长因子， 并尝试新的载体材料来输送生长因子。 这些 研究对于提供下一个阶段所需的信息至关重要。 这一步就是人体临床试验。 如果治疗成功， 将对脊柱患者的护理产生重大影响， 在5-35%的患者中， 第一次尝试就进行了脊柱融合 P51 RR 00165 -36 1996年1月1日- 12/31/1996耶基斯区域灵长类动物研究中心