Immunobiology of Xenotransplantation (U19 Clinical Trial Not Allowed) | RFA AI 24 020

Opportunity Information: Apply for RFA AI 24 020

The Immunobiology of Xenotransplantation (U19 Clinical Trial Not Allowed) funding opportunity (RFA-AI-24-020) is a National Institutes of Health (NIH) cooperative agreement that supports a multi-center research effort called the Immunobiology of Xenotransplantation Cooperative Research Program (IXCRP). The program is aimed at accelerating progress in xenotransplantation by tackling the key immune and physiologic hurdles that currently limit safety and effectiveness when transplanting organs or tissues from pigs into primate or human settings. The work is explicitly preclinical and is meant to generate the mechanistic understanding and practical strategies needed to make xenotransplantation more reliable and clinically translatable, without directly funding human clinical trials under this announcement.

The scientific focus is on resolving immunologic and physiologic barriers to successful xenotransplantation. In practical terms, that means studying how the recipient immune system responds to pig grafts and identifying ways to prevent or control rejection and other damaging immune reactions. It also includes understanding non-immune challenges that can cause graft injury or failure, such as physiologic incompatibilities between species, inflammatory responses, coagulation or vascular issues, and organ-specific functional barriers that could prevent a transplanted pig organ from working normally in a recipient environment. The intent is to move beyond proof-of-concept and address the core biology that determines whether pig-derived grafts can function safely over meaningful timeframes.

The research models supported by this program are pig-to-nonhuman primate (NHP) studies and pig-to-human decedent models. The target graft types include pancreatic islets, kidney, heart, lung, and liver xenotransplantation. By concentrating on these organs and tissues and using rigorous preclinical models, the program is designed to produce data and insights that can inform future clinical development while keeping the supported work within a non-clinical-trial scope for this specific opportunity.

This is a U19 cooperative agreement mechanism, which generally indicates a structured, collaborative program with substantial scientific coordination across multiple components and sites, often with close interaction with NIH program staff compared to standard investigator-initiated grants. The cooperative structure reflects the multi-center nature of IXCRP and the expectation that funded teams contribute to an integrated program that collectively advances shared goals in xenotransplant immunobiology rather than operating as isolated projects.

Eligibility is broad across many U.S.-based organization types, including state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; Native American tribal governments (federally recognized) and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education in those categories); for-profit organizations (other than small businesses); and small businesses. The announcement also 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, and U.S. territories or possessions.

At the same time, the opportunity draws clear boundaries around foreign involvement. 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 in the NIH Grants Policy Statement, are allowed. In other words, the applicant organization must be eligible and domestic, but certain types of foreign collaboration may be permissible if structured as NIH-defined foreign components within an otherwise eligible application.

Administratively, this opportunity falls under the health funding activity category and is associated with CFDA number 93.855. The original application closing date listed is 2024-08-09, and the opportunity was created on 2024-04-01. The announcement title includes "Clinical Trial Not Allowed," signaling that the proposed work must remain within preclinical or otherwise non-clinical-trial research boundaries as understood by NIH policy, even though the overarching goal is to enable safer and more effective xenotransplantation in the long run.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Immunobiology of Xenotransplantation (U19 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.

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