Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) Clinical Trial Not Allowed

The National Institutes of Health (NIH), specifically the National Center for Advancing Translational Sciences (NCATS), is offering funding under the program titled "Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) Clinical Trial Not Allowed." This initiative is part of the Small Business Technology Transfer (STTR) cooperative agreement mechanism and is designed to support the development of therapeutic platforms utilizing extracellular vesicles (EVs) in regenerative medicine. The program encompasses both Phase I (UT1) and Phase II (UT2) funding tracks and is oriented toward platform-based technology development focused on large-scale GMP production, manufacturing, and therapeutic application of EVs for tissue and organ repair. The main objective of this opportunity is to foster the development of native or engineered EVs with therapeutic potential for specific, targeted tissue and organ regeneration. The use of EVs offers advantages such as the ability to cross biological barriers, low immunogenicity, and stability during storage. This funding opportunity builds on previous NIH investments in EV biology and regenerative medicine, including initiatives like the Extracellular RNA Communication Program and the Stem Cell Translation Laboratory. The program targets significant technological challenges such as scaling EV production and refining isolation and purification techniques for clinical applications. Applicants must be U.S.-based small business concerns (SBCs) meeting stringent ownership and operational criteria. Non-domestic organizations and components are not eligible. Eligible applicants must be for-profit entities organized in the U.S., with a majority ownership by U.S. citizens or permanent residents. The FOA specifically excludes projects centered on liposome or nanoparticle-based therapeutics or those that fall outside the scope of regenerative medicine. The application process requires various registrations, including SAM, UEI, eRA Commons, and Grants.gov, and mandates the submission of milestones, commercialization plans, and detailed budgets. The application deadlines for this funding cycle include June 6, 2025, and October 6, 2025, with letters of intent due 30 days prior to submission. Applications must be submitted by 5:00 PM local time of the applicant organization. Awards are anticipated to start in April or July of the following year, depending on the review cycle. Phase I awards can receive up to $295,924 in total costs for one year, while Phase II awards can reach up to $1,972,828 over two years. Higher amounts may be considered under special waiver topics listed by NIH. The review process evaluates applications based on significance, innovation, approach, and investigator expertise, with a strong emphasis on commercialization potential and FDA engagement for regulatory planning. The application must detail the manufacturing environment, potential market, and strategy for IND submission. Contact persons for inquiries include Dr. Christine Happel and Dr. Meena Rajagopal for scientific/research matters, Marilyn Moore-Hoon for peer review, and Imoni Williams for financial/grant management.

Engage with FDA OTAT early (esp. for Phase II) Use approved budget waiver topics if requesting above standard award ceiling Include detailed milestones and commercialization strategy Ensure compliance with all application guide instructions