Clinical Islet Transplantation: Clinical Centers

The summary for the Clinical Islet Transplantation: Clinical Centers grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the National Institutes of Health, which is the U.S. government agency offering this grant.

Clinical Islet Transplantation: Clinical Centers: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute of Allergy and Infectious Diseases (NIAID) invite applications for Clinical Centers to participate in a consortium of investigators and institutions that will perform studies of islet transplantation in patients with type 1 diabetes mellitus (T1D). This consortium will develop and implement a program of single- and/or multi- center clinical studies, accompanied by mechanistic studies, in islet transplantation with or without accompanying kidney transplantation, for the treatment of T1D. Successful applicants for Clinical Centers, together with a Data Coordinating Center (see below), will constitute a Clinical Islet Transplantation (CIT) consortium whose aim is to design and implement human islet transplantation studies that will result in improved treatment of T1D. Responsive applications for Clinical Center support will describe a clinical study of islet transplantation as well as a mechanistic study that will enhance current knowledge in specific key areas related to islet transplantation, as described in "Research Objectives" below. It is expected that successful applicants will bring a range of experiences and perspectives to this consortium that will inform group decisions and accelerate the pace of progress toward general clinical applicability of islet transplantation for the treatment of T1D. Specifically, applicants must have successful experience in islet cell transplantation, thorough knowledge of the current state of the science, and an understanding of the evolving FDA guidance on the development of clinical islet transplantation so that they can contribute to achieving the following CIT objectives: (1) Develop a scientific agenda for clinical and mechanistic studies in islet transplantation that is consistent with the research objectives described in this RFA. (2) Design and implement studies consistent with the scientific agenda. These studies may be performed by single centers within the consortium or by multiple centers implementing a single protocol, as required by the study design. (3) Share information and resources that will advance the field of islet transplantation. A complementary solicitation (RFA 04-004) will establish a CIT Data Coordinating Center (CIT-DCC) that will provide organization of study group meetings, assistance with protocol and manual of operations development, biostatistical support, data monitoring, core laboratory support and coordination, assistance with regulatory submissions, training and monitoring at clinical sites, drug distribution, reporting of adverse events, and other organizational and administrative support as needed. Institutions applying to become Clinical Centers (CC) may also apply for the CIT-DCC solicited under RFA DK-04-004. In order to ensure that data analysis is done independently of data acquisition, the CIT-DCC cannot have overlap in personnel with a CIT-CC. An institution may apply for both a CIT-CC and the CIT-DCC, but each application must have separate principal investigators and include a specific plan documenting how the independent operation (i.e., confidentiality of the study-wide data) of each unit will be maintained.