Clinical development of H-Guard, a novel hemocompatibility coating for haemodialysis

H-Guard（一种用于血液透析的新型血液相容性涂层）的临床开发

• 批准号: 10019004
• 金额: $ 132.8万
• 依托单位: INVIZIUS LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10019004
• 关键词: Clinical; development; Guard; novel; hemocompatibility

Globally, there are 3.2 million patients treated for end-stage renal disease (ESRD), a number increasing by 6% each year. A kidney transplant is the best hope for ESRD patients and can allow them to lead a normal life. Unfortunately, due to a lack of suitable donor organs, and the risks of transplant, most patients with kidney failure will never receive a transplant. These patients depend on dialysis to stay alive. Haemodialysis is the most common type of chronic dialysis, a procedure which is typically required 3x per week and involves pumping the patient's entire blood supply through an artificial kidney called a "dialyser", providing an artificial means of removing the fluid and waste products that healthy kidneys normally remove. Shockingly, life expectancy on dialysis is just one-third of normal, with half of patients receiving haemodialysis dying from cardiovascular complications.Stress and damage to cardiovascular health during the haemodialysis procedure is caused by inflammatory processes initiated by the patient's innate immune system which recognises the dialysis membrane as a large foreign body and attacks it. Although the damage from a single haemodialysis session is slight, the repetitive nature of the procedure generally leads to more profound damage, complications, and death. The inflammation is also associated with the flu-like symptoms commonly experienced after dialysis, which are often highly debilitating for patients, significantly reducing their quality of life.Invizius Limited are developing the H-Guard technology to address this long-standing and critical healthcare need. H-Guard is a novel medical device coating technology which acts like an 'invisibility cloak' to hide the dialysers from the immune system and prevent the inflammatory processes. By preventing the immune response and ensuing inflammation, H-Guard will significantly reduce cardiovascular damage, extend haemodialysis patient life expectancy and reduce healthcare costs associated with hospitalisations and the treatment of cardiovascular complications.This project aims to deliver a First-in-Human study to assess the safety and performance of (acute) H-Guard administration as a priming solution to coat dialysers and blood tubing sets during the standard clinical dialysis set-up prior to use in haemodialysis patients. Outcomes from this project will enable Invizius to progress rapidly through further clinical studies to gain regulatory approval in Europe by 2026\.

全球有320万终末期肾病（ESRD）患者接受治疗，这一数字每年增加6%。肾脏移植是终末期肾病患者最大的希望，可以让他们过上正常的生活。不幸的是，由于缺乏合适的供体器官和移植的风险，大多数肾衰竭患者永远不会接受移植。这些病人依靠透析来维持生命。血液透析是最常见的慢性透析类型，这一过程通常每周需要3次，包括通过一个称为“透析器”的人工肾脏泵送患者的全部血液供应，提供一种人工手段来清除正常情况下健康肾脏排出的液体和废物。令人震惊的是，透析患者的预期寿命只有正常人的三分之一，接受血液透析的患者中有一半死于心血管并发症。在血液透析过程中，压力和心血管健康的损害是由患者的先天免疫系统发起的炎症过程引起的，该系统将透析膜识别为一个大的异物并攻击它。虽然单次血液透析造成的损害是轻微的，但该过程的重复性通常会导致更严重的损害、并发症和死亡。这种炎症还与透析后常见的流感样症状有关，这些症状往往使患者非常虚弱，大大降低了他们的生活质量。Invizius有限公司正在开发H-Guard技术，以解决这一长期和关键的医疗保健需求。H-Guard是一种新型的医疗设备涂层技术，它的作用就像一件“隐形斗篷”，可以将透析器隐藏在免疫系统之外，防止炎症过程。通过预防免疫反应和随后的炎症，H-Guard将显著减少心血管损伤，延长血液透析患者的预期寿命，降低与住院和心血管并发症治疗相关的医疗费用。该项目旨在提供一项首次人体研究，以评估（急性）H-Guard给药在血液透析患者使用之前的标准临床透析设置期间作为涂层透析器和血管组的起始溶液的安全性和性能。该项目的结果将使Invizius能够通过进一步的临床研究迅速取得进展，并于2026年获得欧洲监管机构的批准。