Portable Gas Perfusion System for Pancreas Preservation

用于保存胰腺的便携式气体灌注系统

• 批准号: 8001463
• 负责人: KLEARCHOS K PAPAS
• 金额: $ 81.53万
• 依托单位: GINER, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8001463
• 关键词: Allogenic; Arts; Benchmarking; Biological Assay; Biological Preservation; Blood capillaries; Clinical; Communities; Computer Systems Development; Cryopreservation; Data; Development; Diabetes Mellitus; Effectiveness; Electronics; Engineering; Equipment; Family suidae; Future; Gases; Goals; Heart; Histology; Hour; Human; Humidity; Institutes; Insulin-Dependent Diabetes Mellitus; Islets of Langerhans; Islets of Langerhans Transplantation; Kidney; Laboratories; Legal patent; Liver; Lobe; Logistics; Measurement; Measures; Medical; Methods; Minnesota; Modeling; NMR Spectroscopy; Nude Mice; Organ; Organ Donor; Organ Preservation; Organ Procurements; Outcome; Oxygen; Oxygen Consumption; Pancreas; Perfusion; Phase; Preservation Technique; Procedures; Process; Protocols documentation; Public Health; Quantitative Microscopy; Recovery; Research; Schedule; Shipping; Ships; Simulate; Small Business Innovation Research Grant; Stream; System; Techniques; Technology; Temperature; Testing; Time; Tissues; Transplantation; Universities; Work; capillary; clinical application; cost effective; design; experience; improved; insulin secretion; interest; islet; novel; operation; programs; prototype; public health relevance; research and development; research study

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.

描述（由申请人提供）：用于胰腺保存的便携式气体灌注系统。第二阶段SBIR计划提出了进一步发展新的胰腺保存技术和系统，为未来的实施与人类胰腺临床胰岛移植。迫切需要提高胰腺保存的方法，从而提高胰岛产量和质量，并最终提高临床结果，以推动胰岛移植领域向前发展，用于治疗1型糖尿病。在第一阶段中，胰腺在储存期间的动脉灌注以在毛细血管水平上为整个器官提供氧气是可行的，有前途的，并且上级当前最先进的技术水平。灌注是用气流灌注器官以提供氧气的术语。在阶段I中，胰腺保存长达24小时，并且具有优于用标准双层方法储存的那些的上级质量（通过组织学、显微镜和定量胰岛质量测量）。该SBIR II期项目计划同时提供先进的工程设备和先进的研究证明，以证明胰腺灌注作为一种上级器官保存技术的有效性。该项目结合了Giner公司的专业知识，一家工程研发公司和明尼苏达大学舒尔茨糖尿病研究所，一家领先的胰岛移植中心。II期项目的具体目标是：1）制造充注器原型; 2）开发集成的便携式充注系统：胰腺保存系统; 3）证明冷保存期间的充注可以延长胰腺保存时间; 4）证明标准冷保存后的充注可以提高胰岛质量; 5）制造10个集成的便携式充注系统;和6）展示胰腺保存系统与货物。II期研究工作现在包括人胰腺的灌注，因为在I期研究中进行了非常有前途的人体器官初步研究。在II期研究工作中纳入人类胰腺试验，使充注保存更接近人类胰岛同种异体移植的最终临床应用。猪胰腺也用于某些任务，因为它们仍然是一个很好的模型，并且它们的采购可以安排;在人类胰岛异种移植中也有长期的临床应用。氧气吹入系统将是可靠的，易于使用，可运输的，并将提供一个完整的，专利系统的标准化使用在胰岛移植界。总体项目目标是提供用于胰腺储存和运输的商业设备，并采用新的充气保存方案。此外，氧气全吹系统可以容易地适用于保存和运输其他器官，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。 公共卫生关系：拟议的二期SBIR项目继续开发通过氧合改善供体胰腺保存的技术。胰岛从供体胰腺分离并用于同种异体胰岛移植，这是一种治疗I型糖尿病严重病例的实验程序。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。