SBIR Phase I: Development of a Peripheral Nerve Matrix Conduit to Enable Nerve Regeneration

这一小型企业创新研究(SBIR)项目的更广泛影响/商业潜力涉及神经修复生物材料开发的推进。仅在美国，外科医生每年就会进行大约55万例手术，以修复受创伤性或医源性神经损伤影响的周围神经，这些损伤与每年超过1500亿美元的员工生产力损失带来的经济负担相关。周围神经损伤(PNI)严重影响患者的生活质量、生产力和人际关系。现有材料主要用于被动支持或预防并发症(如机械不稳定、神经瘤或与自体移植相关的供区并发症)。这些产品中没有一种在功能结果方面显示出临床改善。因此，任何可以加速或改善神经修复的技术或方法都是非常有意义的，因为它可以提高神经损伤患者的生活质量，并减轻与神经损伤患者长期残疾相关的经济负担。这个SBIR第一阶段项目建议进行猪组织神经导管的初步开发和测试。该方案的目的是制造具有合适的机械、结构和生物特性的导管，为神经间隙损伤的神经修复和再生提供理想的环境。拟议的工作包括该管道的开发和体外特性，以及在小动物神经间隙修复模型中的体内测试。这项动物研究将比较所建议的导管与商业上可获得的导管和自体移植所获得的功能结果。初步研究表明，拟议的管道有可能促进神经再生过程中的关键早期事件，导致功能性神经组织的形成。预期的结果是，拟议的导管将优于现有的神经引导和同种异体移植，使神经修复得到改善，并改善受影响患者的临床护理。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project involves the advancement of biomaterials development for nerve repair. Each year in the U.S. alone, surgeons perform around 550,000 procedures to repair peripheral nerves affected by traumatic or iatrogenic nerve injury, which are associated with an economic burden due to loss in employee productivity in excess of $150B per year. Peripheral Nerve Injury (PNI) can severely impact the quality of life, productivity, and interpersonal relationships of injured patients. Existing materials are primarily indicated for use as passive support or to prevent complications (e.g., mechanical instability, neuroma, or donor site morbidity associated with autograft). None of these products has shown clinical improvement in functional outcomes. As such, any technology or method that can accelerate or improve nerve repair is of significant interest as it can improve quality of life for those with nerve injuries and reduce the economic burden associated with long term disability for those with nerve injuries.This SBIR Phase I project proposes to undertake the initial development and testing of a porcine tissue-based nerve conduit. The objective of this proposal is to fabricate conduits that have suitable mechanical, structural, and biological properties to provide an ideal environment for nerve repair and regeneration in nerve gap injuries. The proposed work includes the development and in vitro characterization of the conduit, as well as in vivo testing in a small animal model of nerve gap repair. The animal study will compare the functional outcomes obtained with the proposed conduits with those obtained with commercially available conduits and autografts. Pilot studies have suggested that the proposed conduits have the potential to promote key early events in the nerve regeneration process leading to the formation of functional nerve tissue. The expected outcome is that the proposed conduits will be superior to existing nerve guides and allografts, enabling improvements in nerve repair and providing improvements in the clinical care of affected patients.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.