ENHANCEMENT OF LUMBAR FUSION W/ RHBMP 2/COLLAGEN

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， 重组DNA合成的骨诱导生长因子 技术已经被证明可以在异位诱导骨形成 网站。重组人骨形态发生蛋白-2(rhBMP-2)在 在兔子模型中进行脊柱融合。要确定 人用生长因子的适宜剂量及测定 在愈合的速度上，已经选择了一个非人类的灵长类模型。 在灵长类动物体内制造骨骼所需的剂量比预期的要高， 但它是成功的。增长因子成功交付 在一个中空的钛螺纹融合器内，通过一个最小的 有侵入性的方法。下一年的研究将集中在 精确的剂量和探索替代载体材料 更好地绑定增长因子。这些研究对于 提供下一步所需的信息，即胡曼 临床试验。这种治疗如果成功，将极大地 对脊柱患者护理和预防多次手术的影响 5%-35%的患者在第一次脊柱融合时没有愈合 尝试。P51RR00165-36 1996年1月1日-1996年12月31日耶尔克斯地区灵长类 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 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 the following year will focus on the precise dose and exploring alternative carrier materials that will better bind the growth factor. These studies are critical to providing the information needed for the next step which is hu man 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