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

腰椎融合术通常在人类身上进行，但 据报道，骨愈合的失败率为5%-36%。最近， 从牛长骨中分离出的骨诱导生长因子具有 已被证明可以在异位部位诱导骨形成。一头牛 衍生骨蛋白(BP)已被有效地用于生成脊柱 在兔子模型中进行融合。以确定适当的剂量 人类使用的生长因子和确定愈合速度的一种 选择了非人灵长类动物模型。26只恒河猴 腰椎融合术并植入BP萃取物 以脱钙骨颗粒或自体骨颗粒为载体输送 骨移植(对照)于1994年。动物们忍受着外科手术 程序良好和初步结果表明，蛋白质将 在高等动物身上形成骨骼。骨诱导剂的所需剂量 骨骼蛋白高于体型较小的动物。这个 1995年植入的动物表明，脑细胞的形成比 在较高剂量时可靠。来年的研究将是 旨在最终确定人体临床试验所需的剂量， 尝试一种具有油灰稠度的新形式的生长因子 并尝试新的载体材料来提供增长因素。这些 研究对于提供下一步所需的信息至关重要 这是人体临床试验的一步。这种疗法，如果成功的话， 将对脊柱患者的护理产生重大影响，并防止 5%-35%的未治愈的患者接受了多次手术 第一次尝试脊柱融合。P51RR00165-36 1996年1月1日- 1996年12月31日耶克斯地区灵长类研究中心

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