GINER INC — Department of Health and Human Services STTR Phase I: NIDDK

Description

DESCRIPTION provided by applicant Portable Multimode Persufflation Perfusion System for Extended Hypothermic Kidney Preservation In over patients in the US started treatment for end stage renal disease ESRD These patients spend on average $ annually on treatment including dialysis In The U S the current waiting list for organ transplantation holds over patients in need of a new kidney and has been growing exponentially since Of those patients who do undergo successful organ transplantation are faced with further challenges of vitality longevity and cost For example transplanted organs last only years on average after which time the patient may need to be put back on the waiting list It is widely recognized that organs exposed to short warm and or extended cold ischemia do not perform as well as organs with less ischemic time Minimizing ischemia and its effects are critical in improving organ outcomes Currently methods of organ preservation are based on static cold storage SCS which are incapable of sufficiently oxygenating the organ Oxygen has been shown to be the rate limiting nutrient in stored tissue even under hypothermic storage Gaseous perfusion persufflation provides humidified oxygen gas through the vasculature of the organ Hypothermic humidified persufflation of organs has been demonstrated to better preserve and recondition a variety of organs and tissues such as heart liver pancreas kidneys and limbs It has also been shown to enable the use of donated after cardiac death DCD hearts pancreases livers and kidneys in small and large animal experiments Persufflation enables the maintenance of cellular energy stores ATP during cold storage it also has been shown to preserve normal profiles of immunological and molecular markers as opposed to control organs exposed to static cold storage that exhibit abnormal and damaging profiles especially upon rewarming The overall goal of the technology is to improve organ quality for the same or longer storage time particularly for DCD organs This would contribute to more patients treated and better treatment outcomes The objective of this Phase I STTR is to develop a kidney specific portable multimodal persufflation perfusion system that can switch between gas persufflation and liquid perfusion The system will be used in the development of new extended organ preservation protocols and advanced organ quality assessment measurements using porcine kidneys as a model The multimodal kidney persufflation perfusion system will enable the use of one system for complete enhanced kidney preservation and assessment PUBLIC HEALTH RELEVANCE For patients suffering from end stage kidney disease ESRD a kidney transplant can extend life improve quality of life and decrease annual costs by a factor of three compared to hemodialysis This project seeks to increase the currently limited number of kidneys available for transplantation by enabling the use of expanded criteria donors with better outcomes To this end a multimodal kidney persufflation perfusion system will be developed for use in a novel kidney preservation protocol