Portable Gas Perfusion System for Pancreas Preservation

描述(申请人提供)：便携式胰腺保存气体灌流系统。第二阶段的SBIR计划是为了进一步开发新的胰腺保存技术和系统，以便将来用于临床胰岛移植的人胰腺。为了推动胰岛移植治疗1型糖尿病的领域向前发展，迫切需要加强胰岛保存的方法，从而提高胰岛产量和质量，并最终改善临床结果。在第一阶段中，在储存期间对胰腺进行动脉充盈以在毛细血管水平上向整个器官提供氧气是可行的、有希望的，并且优于目前的最先进水平。充气是用气流向器官灌流以提供氧气的术语。在第一阶段，胰腺保存长达24小时，其质量(通过组织学、显微镜和定量胰岛质量测量)优于标准两层法保存的胰腺。这一SBIR第二阶段计划同时提供先进的工程设备和先进的研究演示，证明胰腺充盈作为一种优越的器官保存技术的有效性。该项目结合了工程研发公司Giner，Inc.和领先的胰岛移植中心明尼苏达大学舒尔茨糖尿病研究所的专业知识。第二阶段计划的具体目标是：1)制造充气器原型；2)开发集成的便携式充气系统：胰腺保存系统；3)证明冷保存期间的充气可以延长胰腺保存时间；4)证明标准冷保存后的充气可以提高胰岛质量；5)制造10个集成的便携式充气系统；以及6)通过发货展示胰腺保存系统。Ph II的工作现在包括人体胰腺的充盈，因为在Ph I中进行了非常有希望的人体器官的初步工作，将人胰腺测试纳入Ph II研究工作使充盈保存更接近于人类同种异体胰岛移植的最终临床应用。猪胰腺也被用于一些任务，因为它们仍然是一个很好的模型，而且它们的获取可以安排时间；在人类胰岛异种移植中也有长期的临床应用。氧气充盈系统将是可靠的、易于使用的、可运输的，并将为胰岛移植社区的标准化使用提供完整的专利系统。该项目的总体目标是为胰腺的储存和运输提供商业设备，并采用新的充气保存方案。此外，充氧系统可以很容易地用于其他器官的保存和运输，包括肝脏、肾脏和心脏。该产品的客户将包括移植中心、胰岛隔离中心和器官采购组织。 与公共卫生相关：拟议的SBIR第二阶段项目继续开发技术，通过充氧改善供体胰腺的保存。胰岛是从供体胰腺中分离出来的，用于同种异体胰岛移植，这是一种治疗重症I型糖尿病的实验程序。改善胰腺保存(延长保存时间、提高胰岛产量和质量)对胰岛移植的临床结果很重要。

DESCRIPTION (provided by applicant): Portable Gas Perfusion System for Pancreas Preservation. A Phase II SBIR program is proposed to further develop the novel pancreas preservation technique and system for future implementation with human pancreata for clinical islet transplantation. Methods to enhance preservation of pancreata with resulting improvements in islet yield and quality, and ultimately in clinical outcome, are urgently needed to move the field of islet transplantation forward for the treatment of type 1 diabetes. Arterial persufflation of the pancreas during storage to provide oxygen throughout the organ at the capillary level was shown in Phase I to be feasible, promising and superior to the current state-of-the-art. Persufflation is a term for perfusing an organ with a gas stream to provide oxygen. In Phase I, pancreata were preserved for up to 24 hours and had superior quality (by histology, microscopy and quantitative islet quality measurements) to those stored with the standard two layer method. This SBIR Phase II program plans to concurrently provide the advanced engineering equipment and the advanced research demonstrations of the effectiveness of pancreatic persufflation as a superior organ preservation technique. The project combines the expertise of Giner, Inc., an engineering R&D firm, and the University of Minnesota Schulze Diabetes Institute, a leading pancreatic islet transplantation center. The Specific Aims of the Phase II program are to: 1) fabricate persufflator prototypes; 2) develop an integrated, portable persufflation system: the Pancreas Preservation System; 3) demonstrate that persufflation during cold preservation can extend pancreas preservation time; 4) demonstrate that persufflation after standard cold preservation can improve islet quality; 5) fabricate 10 integrated, portable persufflation systems; and 6) demonstrate Pancreas Preservation System with shipments. The Ph II work now includes persufflation of human pancreata, as very promising preliminary work with human organs was performed in Ph I. Inclusion of human pancreata testing in Ph II research effort brings persufflation preservation closer to the final clinical application in human islet allotransplantation. Porcine pancreata are also used in some tasks, as they remain an excellent model and their procurement can be scheduled; there is also a long term clinical application in human islet xenotranplantation. The oxygen persufflation system will be reliable, easy-to-use, transportable, and will provide a complete, patented system for standardized use in the islet transplantation community. The overall project goal is to provide commercial equipment for pancreas storage and shipment with a new persufflation preservation protocol. Furthermore, the oxygen persufflation system can be readily adapted for use in preservation and transport of other organs, including the liver, kidney and heart. Customers for this product will include transplantation centers, islet isolation centers, and Organ Procurement Organizations. PUBLIC HEALTH RELEVANCE: The proposed Phase II SBIR project continues to develop technology for improved preservation of donor pancreata by oxygenation. Pancreatic islets are isolated from donor pancreata and used in allogenic islet transplantation, an experimental procedure for treating severe cases of Type-I diabetes. Improved pancreas preservation (increased storage time, increased islet yield and quality) is important to the clinical outcome of islet transplantation.