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。这项工作导致了人类的启蒙 先导临床试验，一年随访效果良好。 1997年的研究集中在微调必要的剂量和研究 用于生长事实或包括的替代载体材料 陶瓷材料的不同组合 后外侧脊椎。1998年的研究重点是继续 探索替代载体材料，以更好地约束生长 因素，仍然是可再吸收的。这些研究对于 提供人类下一步所需的信息 后路脊柱融合术应用的临床试验。也在 1999年，研究将集中在测试基因治疗提供方法上 一种新的因子LMP-1，可以以更低的成本提供更好的交付 成本。这种治疗如果成功，将对 在5%-35%的人中护理脊柱患者并防止多次手术 第一次尝试不能治愈脊柱融合的患者。 Funding Sofamor-Danek$113,500 4/01/96-3/31/99出版商Boden， 首页--期刊主要分类--期刊细介绍--期刊题录与文摘--期刊详细文摘内容 腹腔镜下应用重组人骨形态发生蛋白-2钛合金前路脊柱融合术 半身螺纹笼。脊椎病杂志，11：95-101,1998。博登， S.D.腰椎后外侧融合的生物学。整形外科。 克莱恩。北方，1998年，29：603-619。桑杜，H.S.和博登，S.D. 脊柱融合的生物强化。整形外科。克莱恩·诺姆， 1998年，29：621-631。P51RR00165-38 1998年1月1日-1998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 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. This work resulted in the initiation of a human pilot clinical trial with excellent results at one year follow-up. Studies in 1997 focused on fine tuning the necessary dose and studying alternative carrier materials for the growth fact or i ncluding different combinations of ceramic materials for use in the posterolateral spine. Studies in 1998 focused on continuing to explore alternative 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 for the posterior spine fusion application. Also in 1999, studies will focus on testing a gene therapy delivery approach of a new factor LMP-1 which may provide better delivery at a lower cost. 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. FUNDING Sofamor-Danek $113,500 4/01/96 - 3/31/99 PUBLICATIONS Boden, S.D., Martin, G.J., Horton, W.C., Truss, T.L. and Sandhu, H.S. Laparoscopic anterior spinal arthrodesis with rhBMP-2 in a titanium Iiterbody threaded cage. J Spinal Disord, 11:95-101, 1998. Boden, S.D. The biology of posterolateral lumbar spine fusion. Orthop. Clin. North Am., 29:603-619, 1998. Sandhu, H.S. and Boden, S.D. Biologic enhancement of spinal fusion. Orthop. Clin North Am, 29:621-631, 1998. P51RR00165-38 1/1/98 - 12/31/98 Yerkes Regional Primate Research Center