Objective of the proposed Islet Cell Resource (ICR) is to continue and further expand the mission of the existing cGMP Islet Cell processing at the University of Miami-Diabetes Research Institute by participating in the proposed network of ICRs. The proposed UM-DRI ICR, together with other selected ICRs, will be responsible for optimization of the procurement of human pancreata from cadaver donors, isolation and quality control of islet cell preparations, distribution of islets for provided applied research or clinical protocols. The proposed ICR will also continue to perform research and development to improve isolation techniques, optimize cellular viability and function, and to improve shipping of human islet cells between centers for research and clinical transplant applications. The proposed UM-DRI ICR has been already working in compliance with the Food and Drug Administration (FDA) Good Manufacturing Practice (GMP) guidelines relevant to Phase cell therapy trials. The objectives of the proposed ICR are to: 1. Optimize the isolation procedures to obtain high yields of functional islet cells. 2. Provide well-characterized islet cells for transplantation into patients with type 1 diabetes. 3. Distribute islet cells to investigators for clinical research or for applied research applications that are in line with the objectives of this RFA. 4. Develop isolation, preservation and shipment procedures that result in maximal islet cell function upon transplantation.
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Leitão, Cristiane Bauermann; Peixoto, Eduardo Moraes Leao; Westphalen, Antonio C et al. (2014) Liver fat accumulation after islet transplantation and graft survival. Cell Transplant 23:1221-7 |
Peixoto, Eduardo Moraes Leao; Bozkurt, Nujen Colak; Messinger, Shari et al. (2014) The use of 1.5-anhydroglucitol for monitoring glycemic control in islet transplant recipients. Cell Transplant 23:1213-9 |
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