Extended Cardiac Preservation

描述（由申请人提供）：拟议的研究旨在大幅改善移植前的人类心脏保存。该模型包括犬心脏的保存和体外循环脱机后6小时观察期内的移植和功能评估。初步 结果表明，在保存40小时后，5个心脏中有5个恢复良好。我们建议开发一种非常简单但高效的保存装置，使临床医生能够毫无困难地采用新的保存方法，安全问题或大量费用。第一阶段主要是为了证明无人看管的设备使用 产生的保存质量与以前用手工方法获得的保存质量相同。第二阶段将进一步使用该设备，以充分优化这种非常有前途的方法，为人类临床试验做准备，这可以在必要时在研究机构进行。现在公认的是，供体和受体之间的良好匹配可以导致移植后10年生存率至少提高50%。的能力 将人类临床心脏保存时间延长到40小时将允许跨大陆的前瞻性匹配，对于潜在的数千名心脏移植接受者，预期临床结果会有实质性的提高。 拟定商业应用：潜在的商业应用包括销售用于保存心脏、其他器官和移植用工程组织的设备、一次性用品、协议、软件和升级。

Description (provided by applicant): The research proposed is designed to enable a substantial improvement in human heart preservation prior to transplantation. The model involves preservation of canine hearts and evaluation by transplantation and functional assessment over a 6-hour observation period following weaning from cardiopulmonary bypass. Preliminary results indicate excellent recovery of 5 out of 5 hearts after preservation for 40 hours. We propose the development of a very simple yet highly effective preservation device that should enable clinicians to employ the new preservation method without difficulty, safety concerns, or substantial expense. Phase I primarily seeks to show that unattended use of the device yields preservation quality that equals what has been obtained previously with manual methods. Phase II would further employ the device to fully optimize this highly promising method in preparation for human clinical trials, which can be done at the Research Institution when warranted. It is now accepted that excellent matching between donors and recipients can result in at least a 50 percent increase in survival rate 10 years after transplantation. The ability to extend human clinical cardiac preservation to 40 hours would allow transcontinental prospective matching, with expected substantial gains in clinical outcome for potentially thousands of heart transplants recipients. PROPOSED COMMERCIAL APPLICATION: Potential commercial applications include marketing of devices, disposables, protocols, software, and upgrades used in the preservation of hearts, other organs, and engineered tissues for transplantation.