I-Corps: Biodegradable Regenerative Spinal Implants

这个i-Corps项目的更广泛的影响/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人和全球250,000至500,000人遭受脊髓损伤，不仅是由于创伤性损伤，而且是由于血管损伤和感染。根据严重程度的不同，脊髓损伤患者即使不是永久性残疾，也会面临长期残疾，往往终身医疗费用超过百万美元。目前，脊髓损伤还没有根治的治疗方法，而广泛而昂贵的康复治疗是许多患者唯一的选择。外科干预的进展已经超越了传统的减压和稳定，发展到在神经再生方面提供有限改善的移植物，但新的实验方法在技术上具有挑战性和昂贵，而恢复时间可能仍然很长。这项拟议的技术旨在通过提供简单易用和容易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、干细胞疗法、医疗植入物和设备。神经损伤是最难愈合的损伤之一，因为在正常的生理条件下，成熟的神经元不会进行细胞分裂。组织移植物是神经损伤手术干预的标准护理，然而供体可用性的限制，以及组织错配和移植物部位的损坏是这些手术的严重缺陷。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，但此类装置无法与传统神经移植手术的功能恢复相匹配。该项目建立在现有的神经引导导管或通道设备的基础上，通过结合生物兼容的生物活性微丝来促进神经愈合。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，并为神经刺激和神经保护离子的受控释放提供导电。这种可生物吸收的神经装置不需要切除手术，因为它以自然和安全的方式降解。总体而言，将生物活性微丝整合到神经引导管道或通道中可以加快神经恢复过程并改善功能结果，同时消除了额外手术的需要。这一奖项反映了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 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.