Miami, FL — September, 2009 — The University of Miami’s Islet Cell Resource Center (ICR), which is funded by the NIH’s National Center for Research Resources, has fulfilled its mission for the past eight years by providing islets of excellent quality for clinical transplantation trials as well as research applications. Miami, together with the other centers that have contributed to the ICR success, has served the scientific community by advancing in the achievement of the specific goals that were identified as aims of the grant:
•to optimize and develop pancreas preservation, islet processing, pre-transplant in-vitro culture techniques to maximize yield, stability and potency of final islet cell products;
•to validate and standardize prospective product release criteria that will allow not only to define islet cell product identity, viability and functional integrity, but also to predict post-transplant function and survival of the transplanted islets or suitability for selected research applications;
• to optimize islet shipment technologies to maximize the number and quality of islet cell products received at remote sites for either clinical or research applications;
•to assure translation of any improvement achieved by the UM-DRI ICR and effective transfer of know-how, standard operating procedures as well as novel protocols, technologies and equipment through training;
•to make available human islets of high quality to selected centers engaged in clinical and basic research through ICR’s implemented allocation mechanisms.
In the current supplemental request, DRI scientists will complement the research sponsored through the parent grant with studies aimed at improving islet isolation and at increasing our islet potency testing to reliably predict islet function prior to transplantation. Improvement in islet isolation will be achieved by identifying the key variables that are associated with success (e.g. temperature, pressure, flow rate) through accurate, real time monitoring. Novel tests of islet potency that will complement the ones studied in the ICR parent grant will include the analysis of stress-activated signaling pathways and the analysis of gene profiles in human islet preparations.
The results will provide information that is key in the definition of islet potency tests that are reliable and predictive of in vivo function, a key requisite for FDA approval of islet transplantation as a procedure for the treatment of patients with type 1 diabetes.