Islet culture, shipping, and infusion device

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44DK069865-03
Agency Tracking Number: DK069865
Amount: $3,764,960.00
Phase: Phase II
Program: SBIR
Awards Year: 2008
Solicitation Year: 2008
Solicitation Topic Code: N/A
Solicitation Number: PHS2007-2
Small Business Information
DUNS: 170969237
HUBZone Owned: Y
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 () -
Business Contact
Phone: (612) 628-9259
Research Institution
DESCRIPTION (provided by applicant): The culture and shipment of islets are an integral part of islet transplant research. Flasks, petri dishes, and bags are the devices used to perform that role. However, these devices have inherent design characteristics that make them poorly suited to the unique needs of islet culture and islet shipping. This results in the use of far too many devices to maintain an islet preparation, a high potential for contamination, severely limited process control, and islet damage during shipping. Unfortunately, little effort has been undertaken to address the problems inherent to existing devices. We propose the creation of a superior device that is ideally suited to oxygenate islets and is tailored to the needs of the islet commun ity. It will be the only device capable of culturing, shipping, and infusing an entire pancreatic islet isolation. This device is referred to as the single layer gas permeable device (SLD). Our investigation is expected to achieve five specific aims. Aim 1 will define a high-density SLD islet culture protocol that provides islets of superior quality and less immunogenicity than possible with existing devices when an entire islet preparation is cultured in a single device for at least seven-days without feed ing. Outcomes will be determined by a variety of techniques including oxygen consumption rate (OCR), OCR/DNA, and molecular profiling. Aim 2 will adapt the SLD from a culture to a shipping device. Aim 3 will create a novel gyroscopic shipping container (GS C) that functions as an incubator without need of electronic controls and maintains the SLD in a standing position independent of how its outer container is oriented during shipping. This essentially allows islets to be cultured during shipping. Aim 4 will verify that the SLD of Aim 2 and the GSC of Aim 3 deliver islet tissue with superior viable islet yield, quality, and reduced immunogenicity relative to existing methods. Aim 5 will modify the SLD for islet transfusion and verify the superiority of the SL D for islet culture, shipping, and infusion relative to existing methods. Project Narrative: Islet transplants hold promise to provide a better quality of life for those afflicted with diabetes and reduce health care cost to society. There are no c ell culture devices on the market that are designed with the attributes needed to efficiently oxygenate islets during culture and shipping. This grant is intended to create a gas permeable device (SLD) that can culture, ship, and infuse islets with maximum efficiency.

* information listed above is at the time of submission.

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