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.
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.
