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

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

What is this funding opportunity?

This opportunity is the National Eye Institute (NEI) Regenerative Medicine Clinical Trial Planning Grant (R34 - Clinical Trials Not Allowed), funding opportunity number PAR 22 135. It is a discretionary NIH grant program designed to support planning activities for early-stage clinical studies in regenerative medicine for the eye, without conducting an actual clinical trial under this award.

Which NIH institute runs this program?

The program is administered by the National Eye Institute (NEI), which is part of the National Institutes of Health (NIH).

Is this grant meant to pay for a clinical trial?

No. This is a clinical trial planning grant, and clinical trials are not allowed under this award. The funding is intended for preparatory work that positions a project for later funding that could support an actual clinical trial or other translational activities.

What is the overall goal of the program?

The goal is to help research teams build the clinical, operational, and regulatory foundation needed to responsibly translate regenerative approaches for vision restoration into humans. The planning period is meant to reduce risk and uncertainty so the team is better positioned to compete for subsequent funding.

How does this opportunity relate to the NEI Audacious Goal Initiative (AGI)?

This R34 planning grant sits within the NEI Audacious Goal Initiative (AGI), which is a focused effort aimed at moving vision science beyond incremental advances and toward the long-term objective of restoring human vision by regenerating key retinal cells and the neural connections they depend on.

What scientific areas are emphasized under the AGI?

The AGI emphasizes regenerative strategies related to two key retinal cell types: photoreceptors (PRCs) and retinal ganglion cells (RGCs). Photoreceptors (rods and cones) convert light into signals, and retinal ganglion cells carry those signals through the optic nerve to the brain.

Why are photoreceptors and retinal ganglion cells a focus?

Many blinding conditions involve damage to, or loss of, photoreceptors and/or retinal ganglion cells. The program highlights the importance of translating regenerative approaches that could restore these cells and their neural connections in humans.

Does the program focus on translating animal model progress to humans?

Yes. While there has been 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.

What kinds of activities can this R34 planning grant support?

Supported activities generally center on planning and preparatory work for a future clinical study. Examples described include refining a proposed clinical protocol, defining eligibility criteria and outcome measures, developing statistical and data-management plans, addressing safety monitoring concepts, creating manuals of procedures, coordinating multi-site logistics (when relevant), and mapping regulatory and oversight pathways.

Can the planning work include regulatory and oversight preparation?

Yes. The opportunity specifically describes planning activities such as mapping out regulatory and oversight pathways and addressing safety monitoring concepts as part of the clinical and operational groundwork.

Can this award support multi-site planning?

Yes. The description notes that planning may include coordinating multi-site logistics where relevant, which can be important for future clinical studies that involve more than one site.

Can this planning grant support development of study documents and procedures?

Yes. The opportunity mentions activities such as creating manuals of procedures and refining the protocol, which are common components of preparing a study for future execution.

Does the planning scope include manufacturing readiness or product characterization?

Yes, where applicable. For regenerative medicine approaches, planning can include aligning on product characterization and manufacturing readiness expectations, and planning for clinical-grade materials or processes.

Is team formation an expected part of the planning effort?

Yes. The description indicates that planning can include assembling the clinical and scientific team needed to execute a later-phase study.

What funding category and instrument apply to this opportunity?

The opportunity falls under the Health funding activity category, and the funding instrument is a grant.

What is the CFDA number associated with this opportunity?

The opportunity is associated with CFDA number 93.867.

What is the maximum award amount (award ceiling)?

The listed award ceiling is $150,000.

Is the expected number of awards provided?

The expected number of awards is not specified in the provided source information.

When was this opportunity created, and what is the closing date listed?

The opportunity was created on March 8, 2022, and the original closing date provided is May 7, 2025.

Who is eligible to apply?

Eligibility is broad and includes many organization types, including: 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 (with or without 501(c)(3) status, other than institutions of higher education); for-profit organizations other than small businesses; and small businesses.

Are minority-serving institutions and community-based organizations eligible?

Yes. The opportunity highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs), as well as faith-based or community-based organizations.

Are federal agencies, U.S. territories, or regional organizations eligible?

Yes. The announcement highlights eligible federal agencies, regional organizations, and U.S. territories or possessions as eligible applicants.

Are non-U.S. entities (foreign organizations) eligible?

Yes. The eligibility list includes non-U.S. entities (foreign organizations).

What is this grant best described as, in practical terms?

It is best understood as a structured, NEI-backed on-ramp to future human studies in retinal regeneration. It funds the planning work needed to responsibly translate promising regenerative strategies toward eventual clinical testing, while making clear that a clinical trial cannot be conducted with this award.