Extracellular Vesicle Therapeutics for Regenerative Medicine (ExTReMe)

The National Institutes of Health (NIH), through the National Center for Advancing Translational Sciences (NCATS), has released a forecast for an upcoming discretionary funding opportunity titled "Extracellular Vesicle Therapeutics for Regenerative Medicine (ExTReMe)." This initiative aligns with NCATS's mission to catalyze the development, demonstration, and dissemination of innovations that reduce, remove, or bypass translational science barriers to more efficient and effective treatments. Specifically, this opportunity supports research on extracellular vesicles (EVs), with a focus on their application as novel therapeutic agents in regenerative medicine. EVs, including exosomes and microvesicles, serve as essential mediators of intercellular communication and carry biologically active molecules such as proteins, nucleic acids, and lipids. These vesicles influence cellular behavior, especially during tissue repair and regeneration, and offer a promising avenue for cell-free therapies. This funding opportunity will target projects that advance the translation of EV-based therapeutic strategies. Among the key application areas are direct EV therapy, using stem cell-isolated EVs manufactured under Good Laboratory Practice (GLP) conditions, and designer EVs, which are engineered to meet the personalized needs of individual patients. The funding mechanism for this grant will be through cooperative agreements, indicating that substantial programmatic involvement from NIH staff is anticipated during the project period. Although specific funding amounts, award ceilings, and floor values are not yet disclosed, this is typical for forecasted opportunities and will be clarified in the official Notice of Funding Opportunity (NOFO) once posted. The opportunity is expected to support several awards but no estimated number has been announced. Importantly, there is no cost-sharing or matching requirement for applicants. Eligible applicants for this program span a wide array of institutional types, including public and state-controlled institutions of higher education, private higher education institutions, nonprofit organizations with 501(c)(3) status (excluding higher education institutions), small businesses, and for-profit organizations other than small businesses. In addition, a variety of government entities such as state, county, and Native American tribal governments (both federally recognized and not), public housing authorities, and independent school districts are eligible. This broad eligibility reflects the funder's intent to foster interdisciplinary and cross-sectoral innovation in the area of regenerative medicine. As this is a forecasted opportunity, applications are not currently being accepted. The estimated post date for the NOFO is October 15, 2025, with an anticipated application due date of February 17, 2026. Award decisions are expected to be announced by December 17, 2026, with funded projects projected to begin on January 18, 2027. Given that this is a new funding initiative forecasted under the authority of 42 U.S. Code § 287a - Cures Acceleration Network, there is no confirmed information yet about recurrence or future cycles, though this may evolve depending on program outcomes and funding availability. Prospective applicants are encouraged to monitor Grants.gov and the NIH website for the official NOFO and detailed submission instructions. For further information or inquiries, applicants may contact Christine Happel, Ph.D., at the National Center for Advancing Translational Sciences by email at christine.happel@nih.gov or by phone at 240-472-7550.