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。1997年的研究旨在 最终确定人体临床试验所需的剂量。下一步工作 将尝试一种具有油灰稠度的新形式的生长因子 并测试新的载体材料，以更好地提供增长因子。 这些研究对于提供所需的信息至关重要 下一步是人体临床试验。这种治疗，如果 成功，将对脊柱患者的护理产生重大影响 并在5%-35%的不做手术的患者中防止多次手术 第一次尝试就能治愈他们的脊柱融合。

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 1997 were aimed at finalizing the required dose for human clinical trials. Future work will try a new form of the growth factor that has a putty consistency and test new carrier materials to better 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.