PI John A. Kellum, MD
McGowan Institute Investigators: Gilles Clermont, MD; William Federspiel, PhD; Yoram Vodovotz, PhD; William Wagner, PhD
Title Systems Engineering of a Pheresis Intervention for Sepsis (SEPsIS)
Summary The NIH has announced the funding of a $7 million grant entitled “Systems Engineering of a Pheresis Intervention for Sepsis (SEPsIS)” to design and test an extracorporeal device for the treatment of severe sepsis, based on the principle of hemoadsorption. John A. Kellum, MD , Department of Critical Care Medicine, will lead a multi-disciplinary team comprised of basic science and clinical researchers, bioengineering and biomaterials experts, and experts in complex systems modeling.
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.
The research team has previously developed and tested an extracorporeal blood purification device for treatment in chronic renal disease and has adapted this device for the treatment of acute inflammatory diseases. They have also developed and partially calibrated—in both rodents and humans—a mathematical model of sepsis. SEPsIS will integrate these two achievements and, through an iterative design process, develop a device that can be used to treat severe sepsis.
The goal of the SEPsIS grant is to design an extracorporeal blood purification device for the treatment of severe sepsis. The project brings together investigators from departments of Bioengineering, Chemical Engineering, Critical Care Medicine, Surgery, Medicine, and Mathematics. Investigators 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.).
McGowan Institute faculty and their roles in the SEPsIS Grant are:
Dr. Gilles Clermont is the Co-Director of the Simulation Core and will focus on simulation and the development of a mathematical model of blood purification. As the project matures, his efforts will also include the design of the clinical pilot study. In years 4 and 5 he takes on the additional responsibility of managing the clinical pilot study and contributing to data analysis and manuscript preparation.
Dr. William Federspiel’s expertise is in biotransport phenomena, especially as related to artificial lungs, blood transport and cardiovascular devices. He is overseeing all aspects of the research on the hemoadsorption device and related models of the hemoadsorption process. Dr. Federspiel will also be responsible for the University component of the design and manufacturing work aimed at developing early investigational prototypes of the hemoadsorption device. He will design, supervise, and coordinate the associated experimental studies, analyze results of experimental and theoretical investigations, and help prepare reports.
Dr. Yoram Vodovotz’s laboratory will be responsible for the large number of cytokine assays required in this project. These cytokine measurements will be used to calibrate the mathematical model of inflammation and to determine the efficacy of hemoadsorption by the hemoadsorption device. His lab has the capability for multiple assays from a single sample making multiple analyses feasible in a small animal model.
Dr. William Wagner is an expert in the area of cardiovascular device biocompatibility, having worked extensively with circulatory and pulmonary support devices. His lab performs evaluations from in vitro surface analyses to clinical trials focusing on thrombosis, thromboembolism, and inflammation. In this partnership, he is responsible for directing the work in the biocompatibility core.
Term 9/28/05 – 8/31/10