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

这个小企业创新研究（SBIR）项目的更广泛的影响/商业潜力涉及神经修复生物材料开发的进步。仅在美国，外科医生每年就进行约55万例手术来修复受创伤性或医源性神经损伤影响的外周神经，这与每年超过1500亿美元的员工生产力损失造成的经济负担有关。周围神经损伤（PNI）会严重影响受伤患者的生活质量，生产力和人际关系。现有材料主要用于被动支撑或预防并发症（例如，机械不稳定性、神经瘤或与自体移植物相关的供体部位发病率）。这些产品均未显示出功能结局的临床改善。因此，任何能够加速或改善神经修复的技术或方法都具有重要意义，因为它可以提高神经损伤患者的生活质量，并减轻神经损伤患者长期残疾的经济负担。SBIR第一阶段项目建议进行基于猪组织的神经导管的初步开发和测试。 本提案的目的是制造具有合适的机械、结构和生物学特性的导管，以提供神经间隙损伤中神经修复和再生的理想环境。拟议的工作包括导管的开发和体外表征，以及在神经间隙修复的小动物模型中的体内测试。动物研究将比较使用申报导管与市售导管和自体移植物获得的功能结局。初步研究表明，所提出的导管有可能促进神经再生过程中的关键早期事件，从而形成功能性神经组织。预期的结果是，拟议的管道将上级现有的神经导管和同种异体移植物，使神经修复的改善和改善受影响患者的临床护理。该奖项反映了NSF的法定使命，并已被认为值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。

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.