BIOELASTIC MATERIAL TO PREVENT POST-LAMINECTOMY ADHESION

防止椎板切除术后粘连的生物弹性材料

• 批准号: 6387840
• 负责人: JIE XU
• 金额: $ 37.69万
• 依托单位: BIOELASTICS RESEARCH, LTD
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-03-01 至 2003-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6387840
• 关键词: adhesions; bioengineering /biomedical engineering; biomaterial compatibility; biomaterial development /preparation; biomaterial evaluation; biotherapeutic agent; elasticity; gel; histology; laminectomy; peptide structure; polymers; postoperative complications; protein purification; sheep; spinal disk injury

Using two biocompatible elastic protein-based polymers (in viscolelastic gel and elastic sheet forms), the Phase I study demonstrated both materials to be highly effective in preventing adhesions to the spinal dura in the rabbit laminectomy model. The specific aims of Phase II are: 1) to identify the preferred membrane and/or gel configuration(s) of two biocompatible and resorbable polymer compositions for prevention of adhesions in a large animal laminectomy model, 2) to develop sensitive double radio-label standards for purification and a quality control protocol, 3) to utilize an adult sheep lumbar spine model with laminectomies performed at two non-contiguous levels (L3-L4 and L5-L6) allowing for a randomization of the polymer placement to surgical site, 4) to develop a mechanical test method for assessing the interface between the dura mater and the tested polymer and the epidural fibrotic tissue at the control site, and 5) to complete biocompatibility testing and prepare an IDE application for the preferred polymer(s) and state(s). The physical disability resulting from intervertebral disc herniation constitutes the third most common condition for worker disability in the U.S. An improved outcome of intervertebral disc laminectomy would improve the quality of life and restore function for many millions of disabled Americans. PROPOSED COMMERCIAL APPLICATION: Low back pain, for which intervertebral disc pathology is the major cause, is second only to the common cold for work absenteeism in the United States; it is reported to result in more productivity loss than any other medical condition and in an annual health care cost of $33 billion. Over four million cases of prolapsed intervertebral discs are reported annually in the U.S. Development of materials that would improve the outcome of intervertebral disc laminectomy would clearly be of commercial significance while impacting favorably on medical care costs.

使用两种生物相容性弹性蛋白质基聚合物（粘弹性凝胶和弹性片形式），I期研究证明两种材料在兔椎板切除术模型中均能高效预防硬脊膜粘连。第二阶段的具体目标是：1）鉴定用于在大型动物椎板切除术模型中预防粘连的两种生物相容性和可再吸收的聚合物组合物的优选膜和/或凝胶构型，2）开发用于纯化和质量控制方案的灵敏的双放射性标记标准品，3）利用成年绵羊腰椎模型，在两个非相邻节段进行椎板切除术（L3-L4和L5-L 6）允许聚合物放置到手术部位的随机化，四、开发一种力学测试方法，用于评估硬脑膜和测试聚合物与对照处硬膜外纤维化组织之间的界面研究中心，以及5）完成生物相容性试验，并为首选聚合物和状态准备IDE申请。椎间盘突出导致的身体残疾构成了美国工人残疾的第三大常见条件。椎间盘椎板切除术的改善结果将改善数百万残疾美国人的生活质量并恢复功能。拟定商业应用：在美国，下背痛是仅次于普通感冒的缺勤原因，椎间盘病变是下背痛的主要原因;据报道，下背痛导致的生产力损失比任何其他医疗条件都多，每年的医疗保健费用为330亿美元。在美国，每年报告超过四百万例椎间盘突出病例。开发能够改善椎间盘椎板切除术结果的材料显然具有商业意义，同时有利地影响医疗保健成本。