Development of biofunctionalised graphene nerve conduits (NerveGraft) for nerve regeneration

当神经因创伤或肿瘤切除而受伤时，它通常会被切成两段，在它们之间留下一个空的间隙。随后，这个间隙会导致神经功能的永久性丧失（即缺乏感觉和运动）。2020年，英国仅上肢就报告了9，520例神经损伤。目前的治疗方法包括当神经末端之间的差距很短时，将它们缝合在一起。或者，将神经移植物缝合到神经末端以获得更大的间隙。然而，这两种治疗方法的结果各不相同。为了将神经重新连接到原来的位置（或切断的末端）并重新传输信号，神经细胞需要一个引导通路，例如一个像空心管一样的合成引导线索。该项目旨在完成一种创新神经导管的优化和临床前评估，最近原型化，以克服与可用导管和神经自体移植相关的主要局限性。我们将对产品“神经移植物”进行贸易注册。神经移植物是一种多孔导管，填充有导电纳米纤维。导管和纤维由专利生物降解材料BioHastalex（r）制成。该材料基于在分子水平上共价键合到可生物降解材料上的功能化氧化石墨烯。BioHastalex经过充分测试是无毒的，并已成功用作脂肪干细胞膜以及富血小板血浆（PRP）作为患者伤口愈合的支架。此外，我们的目标是用缩氨酸和生长因子以及在手术过程中从病人脂肪中获得的干细胞来生物功能化纤维。这些单位可以使神经生长得更快。这笔资金将使团队能够根据GLP协议对神经引导的临床前有效性进行商业化研究。Wellcome Trust已经要求我们申请其翻译补助金用于商业化。我们的神经引导器将彻底改变神经损伤患者的治疗，消除当前的缺点，同时缩短手术过程。皇家自由医院拥有最多的知名整形外科医生，其中包括Ash Mosahebi教授，他将监督这项研究，并为项目的下一阶段进行临床植入。商业上，全球神经修复市场的整体销售额估值为13. 3亿美元，预计2022年至2030\年将以7. 65%的复合年增长率（CAGR）增长。

When a nerve is injured due to trauma or tumour resection, it would typically be cut off into two pieces, leaving an empty gap between them. Subsequently, this gap would cause permanent loss of nerve function (i.e. lack of sensation and movement). In 2020, 9,520 nerve injuries were reported in the UK for just upper limbs alone. Current treatments involve sewing the ends of the nerves together when the gap between them is short. Alternatively, a nerve graft would be sewn onto the nerve ends for larger gaps. However, both treatments have variable results.To reconnect the nerve to its original position (or severed end) and re-transmit signals, the nerve cells require a guidance pathway, such as a synthetic guidance cue like a hollow tube.This project aims to complete the optimization and preclinical assessment of an innovative nerve conduit, recently prototyped to overcome the main limitations associated with available conduits and nerve autografting. We will trade register the product "NerveGraft".The NerveGraft is a porous conduit, filled with conductive nanofibres. The conduit and fibres are made from patented biodegradable material, BioHastalex(r). The material is based on functionalised graphene oxide covalently bonded at the molecular levels onto biodegradable materials.BioHastalex is fully tested to be non-toxic and has successfully been used as membranes with adipose stem cells as well as with Platelet-rich plasma (PRP) as a scaffold for wound healing in patients.Furthermore, we aim to biofunctionalise the fibres with peptides and growth factors as well as stem cells obtained from the patient's fat during the surgery. These units can make the nerves grow faster.This funding will enable the team to preclinically investigate the efficacy of the nerve guidance under GLP protocols for commercialisation. For commercialisation the Wellcome Trust has requested we apply for their translational grant.Our nerve guide will revolutionise the treatment of patients suffering from nerve injuries, eliminating current disadvantages while shortening the surgical procedure. Royal Free Hospital has the largest number of renowned plastics surgeons, including Professor Ash Mosahebi, who will supervise this research and conduct the clinical implantation for the next stage of the project.Commercially, overall sales in the global nerve repair market are valued at US$ 1.33 billion and are expected to grow at a compound annual growth rate (CAGR) of 7.65% from 2022 to 2030\.