DESCRIPTION (provided by applicant): Objective of the proposed Islet Cell Resource center at the University of Miami (UM) - Diabetes Research Institute (DRI), is to continuing its leadership role within the ICR network, focused on the development and dissemination of improved human islet cell processing and transplantation protocols. The proposed UM-DRI ICR has already been working in compliance with the Food and Drug Administration (FDA) current Good Manufacturing Practice (cGMP) guidelines, relevant to Phase l/ll cell therapy trials and has led the way in the collaborative efforts to develop standardized protocols for islet cell manufacturing to be used by centers participating in the NIH Clinical Islet Transplantation (CIT) consortium. This critically important and synergistic initiative between the ICR (NCRR) and the CIT (NIDDK-NIAID), will result in the standardization of islet manufacturing protocols that will be used in the first FDA Phase III islet transplantation registration trials. In addition to leading the collaborative sharing of information and protocols, and massive coordinating effort required for the completion of the standardized islet manufacturing protocol, the UM-DRI ICR will continue its mission to improve and optimize all aspects of islet cell product manufacturing, from pancreas procurement to islet cell purification, culture, quality control of the final islet cell preparations, shipment and infusion techniques, with the overall objective of maximizing the quality and potency of islet cell products to be used for clinical and research applications, while minimizing the risk or procedure-related complications. The objectives of the proposed ICR are 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. Validate and standardize prospective product release criteria to define islet cell product identity, viability and functional integrity, and to predict post-transplant function. Optimize islet shipment technologies to maximize the number and quality of islet cell products received at remote sites for either clinical or research applications. Continue to train investigators from other ICRs as well as from other institutions, 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, while significantly contributing to the ICR network interactive approach, to enhance collaboration and synergy. Continue making human islets of high quality available to ICR-approved centers, for clinical and research applications.
|Effective start/end date||9/30/01 → 9/29/11|
- National Center for Research Resources: $938,388.00
- National Center for Research Resources: $895,390.00
- National Center for Research Resources: $497,833.00
- National Center for Research Resources: $47,281.00
- National Center for Research Resources: $200,001.00
- National Center for Research Resources: $1,331,668.00
- National Center for Research Resources: $116,119.00
- National Center for Research Resources: $792,200.00
- National Center for Research Resources: $380,000.00
- National Center for Research Resources: $800,000.00
- National Center for Research Resources: $928,149.00
- National Center for Research Resources: $120,000.00
- National Center for Research Resources: $763,662.00
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