The goal of the proposed work is to develop a substantially improved technique of preserving the human pancreas in order to improve the quality of the isolated human islets that are harvested from it for use in human islet transplantation for Type 1 diabetes. Currently, human pancreata are transported with the two layer method (TLM) of storage (8?C), which uses an oxygenated perfluorocarbon solution as an external oxygen reservoir. While the TLM is widely reported to improve islet quality, there are still insufficiencies in the number of viable islets acquired. This is partially attributable to viable islet loss during pancreas storage. Preliminary calculations and experiments indicate that external oxygenation of the pancreas only benefits tissue in the outer rim of the organ leaving the majority of the volume of the pancreas without oxygenation (85-95%). The proposed work will use a novel method of oxygen delivery to the interior of the organ. Another innovative component of the research and development is to develop a system to generate and regulate oxygen delivery to the organ using a portable electrochemical oxygen concentrator/generator. The proposed electrochemical oxygen concentrator uses electrical power to concentrate oxygen from air and release it as pure, humidified oxygen that can be blended with ambient air to give the most efficacious pO2 for the proposed preservation technique. Delivery of gaseous oxygen to the interior of the organ is less complex than full liquid perfusion of the organ. Also the proposed system will be designed to be portable since the main """"""""storage"""""""" time of the pancreas before islet isolation is during its transportation to a facility that specializes in harvesting islets from pancreata. Oxygen will be continuously generated at the desired flow rate and pressure without the need for transporting pressurized gas cylinders. This proposed method has the potential to effect a breakthrough, rather than an incremental improvement, in the quality of islets harvested from the pancreas. The effective treatment of serious cases of Type I Diabetes through pancreatic islet transplant is a high priority in cutting-edge healthcare research, and the proposed work will contribute to the advancement of the field. COMMERCIAL POTENTIAL The preservation system equipment could be a specialty commercial product, supplied to the major organ harvest and transplantation centers. Alternatively, the transportation and preservation of pancreata, using the proposed technique, could be a commercial service. The techniques and equipment could be applicable to the preservation of other organs. KEYWORDS pancreas, pancreata, Type I Diabetes, organ transport, islet transplantation, electrochemical oxygen concentration. ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
5R43DK070400-02
Application #
7216696
Study Section
Special Emphasis Panel (ZRG1-SSMI-K (10))
Program Officer
Arreaza-Rubin, Guillermo
Project Start
2006-04-01
Project End
2009-12-31
Budget Start
2007-04-01
Budget End
2009-12-31
Support Year
2
Fiscal Year
2007
Total Cost
$250,063
Indirect Cost
Name
Giner, Inc.
Department
Type
DUNS #
066594979
City
Newton
State
MA
Country
United States
Zip Code
02466
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