Commercial feasibility of engineered neural tissue

周围神经损伤使人衰弱，导致感觉和运动丧失，在某些情况下还会造成长期疼痛。神经可以通过手术修复，使其再生，但通常损伤会导致很大的间隙，需要桥接。目前修复大间隙的最好方法是使用神经移植，这需要从病人身体的其他地方取一段健康的神经，这在可用的组织数量方面是有限的，并且会导致供体部位的额外功能丧失。Glialign是一家为解决这一问题而成立的新公司。我们的方法将组织工程技术与治疗细胞相结合，以构建模仿天然神经移植物结构和功能的活体替代神经组织（工程神经组织，EngNT）。通过使用安全的细胞和材料植入任何人体内而不会产生免疫排斥反应，EngNT有可能成为一种“现成的”产品，无论何时何地都可以立即用于神经修复。该项目将通过临床前测试和开发强有力的商业案例来评估该技术的临床和商业可行性，从而导致未来的监管和制造开发以及临床试验。

Peripheral nerve injury is debilitating, causing loss of feeling and movement and in some cases long-term pain. Nerves can be repaired surgically to enable regeneration to occur, but often the injury results in a large gap which needs to be bridged. Currently the best way to repair large gaps is to use a nerve graft, which involves taking a healthy nerve section from elsewhere in the patient's body, which is limited in terms of the amount of tissue available and which causes additional loss of function at the donor site. Glialign is a new company set up to develop a solution to this problem. Our approach combines tissue engineering technology with therapeutic cells in order to build living replacement nerve tissue which mimics the structure and function of a natural nerve graft (Engineered Neural Tissue, EngNT). By using cells and materials that are safe to implant into any person without immune rejection, EngNT has the potential to be an 'off the shelf' product, immediately available for nerve repair whenever and wherever it is required. This project will evaluate the clinical and commercial feasibility of the technology through preclinical testing and development of a strong business case, leading to future regulatory and manufacturing development and clinical trials.