Continuation of the Collaborative Islet Transplantation Registry (U01 Clinical Trial Not allowed)

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the U.S. Department of Health and Human Services through the National Institutes of Health, has announced a forecasted opportunity titled Continuation of the Collaborative Islet Transplantation Registry (U01 Clinical Trial Not Allowed). The program is designed to continue a long-standing effort to collect and analyze data from clinical trials involving isolated human islets for the treatment of diabetes. These efforts are meant to support scientific understanding and future development of islet transplantation as a therapeutic strategy. The program will provide the research community with data for publications, presentations, and the design of subsequent clinical trials. The registry will not support new clinical trials directly but will serve as a cooperative agreement that emphasizes the collection, analysis, and dissemination of trial data. The Collaborative Islet Transplantation Registry (CITR) is tasked with preparing periodic reports summarizing transplantation outcomes and identifying trends over time. These summaries are intended to inform the broader public, including researchers, clinicians, and policymakers, of the progress and challenges within the field. Additionally, the registry will facilitate periodic meetings with contributing clinical sites, ensuring active collaboration and knowledge-sharing among stakeholders. Applications for this opportunity are not currently being solicited. Instead, this forecast serves as an advance notice to allow researchers, institutions, and partners time to develop meaningful collaborations and prepare responsive applications. The program will use the U01 Cooperative Agreement mechanism under the Clinical Trial Not Allowed designation, meaning funding is restricted to registry and data analysis activities without direct support for patient enrollment or intervention-based research. Investigators with expertise in clinical trial data collection and analysis are strongly encouraged to prepare proposals. The estimated total program funding available for this opportunity is $700,000, with one award expected. While no ceiling or floor is currently stated, the amount suggests a single large-scale award to support the continuation of registry operations. Matching funds are not required, removing cost-sharing obligations for applicants. The forecast indicates an estimated post date of July 1, 2026, with a full application due date of October 1, 2026. The award is expected to be announced by July 1, 2027, with project activities starting the same day. These dates are subject to confirmation when the final Notice of Funding Opportunity (NOFO) is published. Because the program has been forecasted in advance, applicants have additional time to form collaborations, particularly for multi-institutional data collection and analysis efforts. Eligible applicants include a wide range of entities such as state governments, city and township governments, county governments, special district governments, independent school districts, Native American tribal governments (federally recognized), tribal organizations, public housing authorities, public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with 501(c)(3) status, small businesses, for-profit organizations, and others. Additionally, eligibility extends to federal agencies, U.S. territories, foreign institutions, faith-based and community-based organizations, and regional organizations. This broad eligibility structure reflects the program’s intent to encourage wide participation from diverse entities capable of managing data collection and analysis. The official contact for this opportunity is Thomas L. Eggerman at NIDDK, available via phone at 301-594-8813 or by email at eggermant@extra.niddk.nih.gov. Applicants and interested parties should use this forecast to prepare for the eventual NOFO release, review eligibility requirements, and determine their capacity to contribute to the continuation of this registry.