Reducing time, sample handling, and staff requirements for complement activation monitoring in clinical trials

 描述(由申请人提供)：尽管有压倒性证据表明补体系统与肾脏和心血管结果有关，但严格的技术要求限制了其在临床试验和诊断中的应用。目前的检测方法需要仔细收集样本，立即冷冻，然后运往几个专门的实验室。因此，虽然补体系统蛋白C3和C4在自身免疫性疾病临床上经常被检测，但已知的介导活跃的炎症和自身免疫过程的蛋白水解性分裂产物很少被评估。Kypha Inc.正在开发一个集成的护理点(POC)平台，以使临床试验和诊断应用程序更容易获得可靠的补体数据。这些努力是及时的，因为最近的治疗发展集中在抗炎策略上，包括体外治疗(如血液透析)、自身免疫、移植排斥反应和其他情况下的补体抑制。这一第一阶段提案中的里程碑将证明在护理点使用先进的多重定量侧向血流分析作为一种解决方案的可行性，以减少在临床试验中测量补体激活和炎症所需的资源，为它们在急慢性肾脏和血管炎症疾病的诊断和管理中的充分应用铺平道路。

 DESCRIPTION (provided by applicant): Despite overwhelming evidence that the complement system is involved in kidney and cardiovascular outcomes, stringent technical requirements limit its inclusion in clinical trials and diagnostics. Current protocols require careful sample collectin, immediate freezing, and shipping to only a few specialized labs. As a result, while complement system proteins C3 and C4 are routinely measured in autoimmune disease clinics, proteolytically activated split products known to mediate active inflammatory and autoimmune processes are rarely assessed. Kypha Inc. is developing an integrated point-of-care (POC) platform to make reliable complement data more accessible to clinical trials and diagnostic applications. These efforts are timely due to recent therapeutic development focused on anti-inflammatory strategies including complement inhibition for extracorporeal therapies (such as hemodialysis), autoimmunity, transplant rejection, and other conditions. Milestones in this Phase I proposal will demonstrate the feasibility of using advanced multiplex quantitative lateral flow assays in the point of care as a solution that decreases the resources required to measure complement activation and inflammation in clinical trials, paving the way for their full utility inthe diagnosis and management of acute and chronic renal and vascular inflammatory diseases.