Immunobiology of Xenotransplantation (U01 Clinical Trial Not Allowed) | RFA AI 24 019

Opportunity Information: Apply for RFA AI 24 019

The Immunobiology of Xenotransplantation (U01 Clinical Trial Not Allowed) funding opportunity (RFA-AI-24-019) is an NIH discretionary grant that will support a cooperative, multi-center research program called the Immunobiology of Xenotransplantation Cooperative Research Program (IXCRP). The program is focused on tackling key immunologic and physiologic obstacles that currently limit how safe and effective xenotransplantation can be. The work is explicitly preclinical and is intended to generate the kind of mechanistic and translational evidence needed to move the field forward without supporting clinical trials under this announcement.

Scientifically, the central goal is to advance understanding of how the immune system and whole-body physiology respond to pig-to-primate or pig-to-human tissue and organ transplantation, and then to use that knowledge to develop strategies that make xenotransplantation more viable. The NOFO targets research using pig donors and either nonhuman primate (NHP) recipients or human decedent models. The organ and tissue systems highlighted are pancreatic islets, kidney, heart, lung, and liver, which reflects both the clinical need in end-stage organ failure and the distinct immune and physiologic challenges each graft type presents. By emphasizing both immunologic and physiologic barriers, the program signals interest not only in classic rejection mechanisms, but also in issues like inflammation, coagulation and thrombosis, graft function and adaptation, and other systemic responses that can derail xenograft survival even when immune rejection is partially controlled.

As a U01 cooperative agreement, awards made under this opportunity will involve substantial NIH programmatic involvement compared to a typical investigator-initiated research grant. In practice, that usually means awardees are expected to operate as part of a coordinated consortium, align with shared program goals, and participate in collaborative activities such as common protocols, data sharing, and cross-site coordination. The multi-center structure is intended to accelerate progress by bringing together complementary expertise and enabling studies that benefit from harmonized models and comparable outcome measures across institutions.

Eligibility is broad across U.S.-based organizations and includes many common applicant types: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The NOFO also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, tribal governments other than federally recognized entities, and U.S. territories or possessions. At the same time, the announcement makes clear that non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components as defined under the NIH Grants Policy Statement are allowed, which means a U.S. applicant can include certain well-justified foreign collaborations or performance sites consistent with NIH policy, even though a foreign organization cannot be the direct applicant.

Administratively, the opportunity is listed under CFDA 93.855 and is run by the National Institutes of Health. The original application due date shown is August 9, 2024, and the funding instrument is a cooperative agreement (U01). The title includes "Clinical Trial Not Allowed," which indicates applications should not propose prospective clinical studies in human participants as clinical trials under NIH definitions, and applicants should frame the work as preclinical xenotransplantation research in the specified models. Overall, the NOFO is aimed at building a coordinated research effort that can systematically reduce the immune and physiologic hurdles to pig-to-primate or pig-to-human decedent xenotransplantation across multiple organ systems, with the long-term intent of enabling safer and more effective future translation.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Immunobiology of Xenotransplantation (U01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2024-04-01.
• Applicants must submit their applications by 2024-08-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA AI 24 019

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: