I-Corps: Biodegradable Regenerative Spinal Implants

这个I-Corps项目更广泛的影响/商业潜力是改善脊髓损伤的治疗和结果。每年，美国约有18，000人，全球约有250，000至500，000人遭受脊髓损伤，不仅是由于创伤性损伤，而且还由于血管损伤和感染。根据严重程度，脊髓损伤患者面临长期的，如果不是永久性的残疾，往往与终身医疗费用超过百万美元。目前，脊髓损伤没有治愈性治疗，而广泛和昂贵的康复治疗是许多患者的唯一选择。手术干预的进展已经超越了经典的减压和稳定移植，这可以提供有限的改善神经再生，但新的实验方法可能在技术上具有挑战性和昂贵的，而恢复时间可能仍然很长。所提出的技术旨在通过提供简单易用且易于获得的组织支架来降低神经修复手术的成本和复杂性，同时通过促进神经元再生来改善长期结果。这个I-Corps项目的基础是开发可生物降解的生物活性材料，用于组织再生、受控药物输送、干细胞治疗、医疗植入物和设备。神经损伤是最难治愈的损伤之一，因为在正常生理条件下，成熟的神经元不进行细胞分裂。组织移植物是神经损伤中外科手术干预的护理标准，然而供体可用性的限制以及组织错配和移植部位的损伤代表了这些手术的严重缺点。或者，由不同材料制成的合成神经引导导管或通道装置已被批准用于临床使用，但此类装置无法匹配传统神经移植手术的功能恢复。该项目建立在现有的神经引导导管或通道装置，通过结合生物相容性生物活性微丝，以改善神经愈合。这种新设备在体内是自然可生物降解和生物可吸收的，机械匹配神经组织，并具有导电性，可用于神经刺激和神经保护离子的受控释放。这种生物可吸收神经器械不需要进行移除手术，因为它以自然和安全的方式降解。总的来说，将生物活性微导线整合到神经引导导管或通道中可以加速神经恢复过程并改善功能结果，同时无需额外的手术。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值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 I-Corps project is to improve treatment and outcomes of spinal cord injury. Annually, approximately 18,000 people in the United States and between 250,000 to 500,000 people globally suffer a spinal cord injury not only as a result of traumatic injuries but also from vascular damage and infections. Depending upon the degree of severity, spinal cord injury patients face lengthy, if not permanent disabilities, often with lifetime medical costs exceeding million dollars. Currently, there are no curative treatment for spinal cord injury while extensive and expensive rehabilitative therapy is the only option for many patients. Advances in surgical interventions have progressed beyond classic decompression and stabilization to grafts which can provide limited improvements in nerve regeneration, but new experimental approaches can be technically challenging and costly while recovery times can remain painfully long. The proposed technology aims to reduce the cost and complexities of neural repair surgery by offering a simple to use and readily available tissue scaffold, while improving long term outcomes by promoting neuronal regrowth. This I-Corps project is based on the development of biodegradable bioactive materials for tissue regeneration, controlled drug delivery, stem cell therapies, medical implants and devices. Nerve injuries are among the most difficult injuries to heal because under normal physiological conditions, mature neurons do not undergo cell division. Tissue grafts are the standard of care for surgical intervention in nerve injuries, however limitations on donor availability, as well as tissue mismatches and damage to the graft site represent serious drawbacks to these procedures. Alternatively, synthetic nerve guidance conduit or channel devices made from different materials have been approved for clinical use, but such devices fail to match the functional recovery of traditional nerve grafting procedures. This project builds upon existing nerve guidance conduit or channel devices by incorporating biocompatible bioactive microwires to improve neural healing. This new device is naturally biodegradable and bioresorbable in the body, mechanically matching neural tissue, and electrically conductive for neural stimulation and controlled release of neuroprotective ions. This bioresorbable neural device does not require removal surgery as it degrades in a natural and safe manner. Overall, the integration of bioactive microwires into nerve guidance conduit or channels can accelerate neural recovery process and improve functional outcome while eliminating the need for additional surgery.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.