Systems Engineering of Pheresis Intervention for Sepsis

作为对PAR-04-023的回应，我们提议建立一个生物工程研究伙伴关系，以设计和测试一个 用于治疗严重脓毒症的体外装置，基于血液吸附原理。我们的多- 学科团队由基础科学和临床研究人员、生物工程和生物材料专家组成， 复杂系统建模专家我们的建议将仔细整合这一多样化的研究人员群体， 技术和生物医学领域，跨越多个科学学科的界限，并利用 工业界和学术界的能力。我们的项目名为单采干预的系统工程 脓毒症（Sepsis）。 严重脓毒症（感染时急性器官衰竭）是一个主要的健康问题， 每年25万美国人，花费数十亿美元。败血症的可用疗法，包括最近 目前已被批准，但仍不理想，迫切需要新的治疗方法。然而，炎症的复杂性 反应网络和高成本的临床试验，特别是在危重病，使传统的 药物/器械开发范式过时。我们之前已经开发并测试了一种体外血液 本发明涉及用于治疗慢性肾病的净化装置，并且已经使该装置适用于治疗急性肾病。 炎症性疾病。我们还开发并部分校准了在啮齿动物和人类中一 脓毒症的数学模型该项目建议将这两项成果结合起来， 迭代设计过程，开发一种可用于治疗严重脓毒症的装置。 本提案的目标是设计一种体外血液净化装置，用于治疗 严重败血症这项提案将汇集来自以下部门的研究人员在大学 匹兹堡：生物工程，化学工程，重症监护医学，外科，医学和数学。 我们还将求助于两家公司的专业知识，其中一家专门从事吸附剂聚合物技术（MedaSorb Technologies，LLC）和其他复杂系统建模（Immunetrics，Inc.）。

In response to: PAR-04-023, we are proposing a Bioengineering Research Partnership to design and test an extracorporeal device for the treatment of severe sepsis, based on the principle of hemoadsorption. Our multi- disciplinary team comprises basic science and clinical researchers, bioengineering and biomaterials experts, and experts in complex systems modeling. Our proposal will carefully integrate this diverse group of researchers from both technical and biomedical fields, crossing the boundaries of multiple scientific disciplines and leveraging the capabilities of both industry and academia. Our project is entitled Systems Engineering of a Pheresis Intervention for Sepsis (SEPsIS). Severe sepsis (acute onset organ failure in the setting of infection) is a major health problem that kills nearly 250,000 Americans each year and costs billions of dollars. Available therapies for sepsis, including those recently approved, are suboptimal and new therapies are urgently needed. However, the complexities of the inflammatory response network and the high cost of clinical trials, particularly in the critically ill, renders the traditional drug/device development paradigm obsolete. We have previously developed and tested an extracorporeal blood purification device for treatment in chronic renal disease and have adapted this device for the treatment of acute inflammatory diseases. We have also developed and partially calibratedin both rodents and humansa mathematical model of sepsis. This project proposes to integrate these two achievements and, through an iterative design process, develop a device that can be used to treat severe sepsis. The goal of this proposal is to design an extracorporeal blood purification device for the treatment of severe sepsis. This proposal will bring together investigators from the following departments at the University of Pittsburgh: Bioengineering, Chemical Engineering, Critical Care Medicine, Surgery, Medicine, and Mathematics. We will also call on the expertise of two companies, one specializing in adsorbent polymer technology (MedaSorb Technologies, LLC) and the other in complex systems modeling (Immunetrics, Inc.).