A Solution to the Kidney Shortage: Exsanguineous Metabolic Support, From Breadbo

肾脏短缺的解决方案：来自 Breadbo 的无血代谢支持

• 批准号: 7928024
• 负责人: Lauren Brasile
• 金额: $ 292.6万
• 依托单位: BREONICS, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7928024
• 关键词: Alabama; Autopsy; Biosensor; Blinded; Canis familiaris; Cardiac Death; Cessation of life; Clinic; Clinical; Clinical Trials; Consult; Consumption; Data; Development; Devices; Discipline; Doctor of Philosophy; Engineering; Funding; Goals; Hour; Human; Infusion Pumps; Jordan; Kidney; Lead; Legal patent; Metabolic; Metabolism; Michigan; New York; Organ; Organ Donations; Organ Preservation; Organ Transplantation; Oxygen; Oxygenators; Phase; Preclinical Testing; Preservation Technique; Process; Protocols documentation; Publications; Recovery; Research Ethics Committees; Resuscitation; Science; Services; Site; Solutions; Support System; System; Technology; Testing; Transplantation; Transplantation Immunology; Universities; Work; base; blood perfusion; clinical application; college; commercialization; design; evaluation/testing; innovative technologies; nanoscale; pre-clinical; preclinical study; product development; programs; prototype; public health relevance; repaired

DESCRIPTION (provided by applicant): BREONICS' Exsanguineous (Bloodless) Metabolic Support (EMS) technology is a disruptive technology that could significantly alter the current paradigm in clinical organ transplantation where demand for organs far outweighs supply. It is the first technology that can be used to intervene after ischemic damage has occurred to resuscitate and repair damaged kidneys. This unique ability is transformational because it changes today's limitation of recovering cadaveric kidneys from within minutes of death to within a window of several hours, thereby radically expanding organ donation criteria. Redefining the existing donor criteria is what makes the technology distinct and why it should not be confused with traditional organ preservation techniques or blood perfusion, where repair of ischemic damage has never been demonstrated. The EMS technology has been developed over the past 12-years and is protected by 12 issued & pending patents. The technology is translational to human kidneys, where canine and human kidneys tested in parallel demonstrated equivalent parameters of metabolism and function. The preclinical data, along with initial proof of concept with human kidneys, provides the basis to move forward to product development and onto pilot clinical trials. Our goal is to transition our technology, with established efficacy in preclinical testing, to the development of a prototype clinical system that will be used to perform pilot clinical trials to repair ischemically damaged kidneys at the University of Michigan and the Cleveland Clinic. This project involves a multidisciplined team consisting of nationally recognized experts in their field that will provide the needed expertise to successfully accomplish our goals. PUBLIC HEALTH RELEVANCE: Exsanguineous Metabolic Support (EMS) is a transformational technology because it changes today's limitation of recovering cadaveric kidneys from within minutes of death to a window of several hours postmortem. EMS can be used to intervene after ischemic damage has occurred to resuscitate and repair damaged kidneys. The potential to redefine donor criteria is what makes EMS technology unique and why it should not be confused with traditional hypothermic preservation techniques or blood perfusion. The technology has been shown to be translational to human kidneys in several publications. We are seeking funding to take our preclinical data, along with initial proof of concept with human kidneys, to product development and on to pilot clinical trials via IRB approval at the University of Michigan and the Cleveland Clinic. It is anticipated that the data from this project will lead to an IDE and the pivotal clinical trials necessary to commercialize the EMS technology. We believe the commercialization of EMS will provide a solution to the world-wide kidney shortage.

描述（由申请人提供）：Breonics的外语（无血）代谢支持（EMS）技术是一种破坏性技术，可以显着改变临床器官移植的当前范式，而对器官对器官的需求远远超过供应。这是在发生缺血性损害后，可用于恢复和修复受损的肾脏后的第一条技术。这种独特的能力具有变革性，因为它改变了当今将尸​​体肾脏从死亡的几分钟之内恢复到几个小时内的限制，从而从根本扩展了器官捐赠标准。重新定义现有的供体标准是使该技术与众不同的原因，以及为什么不应该将其与传统的器官保存技术或血液灌注相混淆，而在没有证明缺血性损害的情况下。 EMS技术是在过去的12年中开发的，并受到12项已发行和申请专利的保护。该技术是人类肾脏的转化，在该肾脏中，并行测试的犬和人肾脏表现出代谢和功能的等效参数。临床前数据以及人类肾脏的最初概念证明，为前进的产品开发和试验临床试验提供了基础。我们的目标是通过在临床前测试中确定的功效过渡我们的技术，以开发原型临床系统，该系统将用于在密歇根大学和克利夫兰诊所进行试验临床试验，以修复降低的肾脏。该项目涉及一个由全国认可的专家组成的多学科团队，该团队将提供所需的专业知识以成功实现我们的目标。 公共卫生相关性：外态代谢支持（EMS）是一种变革技术，因为它改变了当今将尸​​体肾脏从死后几分钟内恢复到验尸后几个小时的窗口。在发生缺血性损伤后，可以使用EMS进行干预，以恢复和修复受损的肾脏。重新定义供体标准的潜力是使EMS技术与众不同的原因，以及为什么不应该将其与传统的低温保存技术或血液灌注相混淆。该技术已被证明是在几个出版物中转化为人类肾脏的。我们正在寻求资金，以获取临床前数据，以及人类肾脏的最初概念证明，产品开发以及通过密歇根大学和克利夫兰诊所的IRB批准进行试验临床试验。可以预料，该项目的数据将导致IDE和EMS技术商业化所需的关键临床试验。我们认为，EMS的商业化将为全球肾脏短缺提供解决方案。