Diabetes mellitus is the fourth leading cause of death by disease in the U.S. Recent studies presented by the Edmonton Group have resulted in a widespread belief that implantation of allogeneic, glucose-responsive, insulin-secreting Islets of Langerhans for the treatment of diabetes mellitus provides a cure. A critical consideration for the nationwide clinical impact of allogeneic islet transplantation is that pancreases are in short supply due to a very brief post-mortem ischemia tolerance. The primary objective of this proposal is to design and test a hypothermic perfusion device for the safe and effective transportation of pancreases. A hypothermic pancreas transporter (PTR) will be constructed based upon preliminary specifications developed in pilot experiments. Porcine pancreases will be placed on the prototype PTR and islet yields and functions determined after varying periods of perfusion. During the testing phase, the design will be continuously reviewed and specifications modified to optimize performance, It is anticipated that specifications for a preclinical PTR will be finalized for safety and efficacy testing in a large animal model in a subsequent Phase II SBIR proposal. It is further anticipated that the availability of a pancreas transporter (PTR) will permit most, if not all, pancreases suitable for transplantation in the U.S. to be utilized. Furthermore, the PTR may permit islets to be banked in long-term storage so that they are available off-the-shelf to clinicians. Banking would allow time for better HLA matching of donors to recipients and enable quality assurance and quality control procedures to be conducted prior to transplantation.
