Portable Gas Perfusion System for Pancreas Preservation

描述（申请人提供）：用于胰腺保存的便携式气体灌注系统。II期SBIR计划旨在进一步发展新的胰腺保存技术和系统，为将来临床胰岛移植的人类胰腺提供支持。为了推进胰岛移植治疗1型糖尿病领域的发展，迫切需要找到方法来加强胰岛的保存，从而提高胰岛的产量和质量，并最终改善临床结果。在I期研究中，胰腺动脉充盈在储存期间为整个器官提供毛细血管水平的氧气是可行的，有希望的，并且优于目前的最新技术。充气是指向器官注入气流以提供氧气的术语。在I期，胰脏保存长达24小时，与标准两层法保存的胰岛相比，其质量（通过组织学、显微镜和定量胰岛质量测量）更好。SBIR二期项目计划同时提供先进的工程设备和先进的研究演示，以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。第二阶段项目的具体目标是：1)制造充气机原型；2)开发一种集成的便携式充血系统：胰腺保存系统；3)低温保存时的灌注可以延长胰腺保存时间；4)证明标准冷藏后的灌注能改善胰岛品质；5)制造10个集成的便携式充气系统；和6)演示胰腺保存系统的装运。Ph II的工作现在包括人类胰腺的充血，因为非常有前途的人体器官的初步工作是在Ph i中进行的。将人类胰腺测试纳入Ph II的研究工作使充血保存更接近于人类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，它们的采购可以安排；在人类胰岛异种移植方面也有长期的临床应用。氧充气式系统将是可靠的，易于使用的，可运输的，并将提供一个完整的，专利系统在胰岛移植界的标准化使用。该项目的总体目标是为胰腺储存和运输提供一种新的充盈保存协议的商用设备。此外，氧气充气式系统可以很容易地适用于保存和运输其他器官，包括肝、肾和心脏。该产品的客户包括移植中心、胰岛分离中心和器官采购组织。

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.