NEI Regenerative Medicine Clinical Trial Planning Grant (R34 - Clinical Trials Not Allowed) | PAR 22 135

Opportunity Information: Apply for PAR 22 135

The NEI Regenerative Medicine Clinical Trial Planning Grant (R34 - Clinical Trials Not Allowed), funding opportunity number PAR 22 135, is a discretionary NIH grant program from the National Eye Institute (NEI) designed to help research teams plan early-stage clinical studies in regenerative medicine for the eye, without actually running a clinical trial under this award. It sits within the NEI Audacious Goal Initiative (AGI), a focused effort to move vision science beyond incremental advances and toward the long-term goal of restoring human vision by regenerating key retinal cells and the neural connections they depend on.

The scientific emphasis of the AGI is on two retinal cell types that are central to vision: photoreceptors (PRCs) and retinal ganglion cells (RGCs). Photoreceptors, commonly known as rods and cones, convert light into signals that represent visual information. Retinal ganglion cells then carry that information out of the eye and through the optic nerve to the brain. Many blinding conditions involve damage or loss of one or both of these cell populations, and while there has been notable progress in animal models (including demonstrations of retinal neuron regeneration and reconnection in systems such as fish and mice), the program is explicitly oriented toward what it will take to translate regenerative approaches into humans. In practical terms, the R34 planning mechanism is meant to support the groundwork required for a future clinical study by helping investigators build the necessary clinical, operational, and regulatory foundation.

Because this is a clinical trial planning grant and clinical trials are not allowed under the award, the supported activities generally center on preparatory work rather than enrolling participants or testing an intervention in humans. Applicants typically use this type of funding to refine a proposed clinical protocol, define eligibility criteria and outcome measures, develop statistical and data-management plans, address safety monitoring concepts, create manuals of procedures, coordinate multi-site logistics where relevant, and map out regulatory and oversight pathways. For regenerative medicine approaches, planning can also include steps like aligning on product characterization and manufacturing readiness expectations (where applicable), planning for clinical-grade materials or processes, and assembling the clinical and scientific team needed to execute a later-phase study. The overall intent is to reduce risk and uncertainty so that, after the planning period, the project is positioned to compete for subsequent funding that would support an actual clinical trial or other translational work.

The opportunity falls under the Health funding activity category and is associated with CFDA number 93.867. The funding instrument is a grant, and the listed award ceiling is $150,000. The opportunity was created on March 8, 2022, and the original closing date provided is May 7, 2025. While the expected number of awards is not specified in the source data provided, the ceiling indicates this is a relatively targeted planning award meant to cover essential planning milestones rather than full development or trial execution costs.

Eligibility is broad and includes many types of organizations that can contribute meaningfully to translational vision research. Eligible applicants include 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 (including those other than federally recognized tribal governments); public housing authorities and Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), 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, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This wide eligibility reflects NEI's interest in drawing on diverse institutional strengths, including clinical centers, academic labs, community-connected organizations, and international expertise where it can accelerate progress toward regenerative vision restoration.

In short, this R34 opportunity is best understood as a structured, NEI-backed on-ramp to future human studies in retinal regeneration. It supports the careful planning needed to responsibly translate promising regenerative strategies for photoreceptors and retinal ganglion cells toward eventual clinical testing, while making clear that the planning grant itself cannot be used to conduct a clinical trial.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NEI Regenerative Medicine Clinical Trial Planning Grant (R34 - Clinical Trials Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.867.
• This funding opportunity was created on 2022-03-08.
• Applicants must submit their applications by 2025-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $150,000.00 in funding.
• 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 PAR 22 135

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