Regenerative Medicine Innovation Projects (RMIP) (UT2 - Clinical Trial Not Allowed) | RFA HL 18 033

Opportunity Information: Apply for RFA HL 18 033

The Regenerative Medicine Innovation Projects (RMIP) funding opportunity (RFA-HL-18-033) is an NIH cooperative agreement (UT2) designed to help small businesses tackle practical, well-known bottlenecks that slow down the development of safe and effective regenerative medicine therapies based on adult stem cells. The program is run by the National Institutes of Health with participation from multiple NIH Institutes and Centers, and it is coordinated with the U.S. Food and Drug Administration, which signals that the work NIH wants supported here is tightly connected to real-world regulatory expectations and the kind of evidence packages companies ultimately need for clinical development. Importantly, this UT2 notice is labeled "Clinical Trial Not Allowed," meaning the supported work is not meant to be a clinical trial; instead, it is focused on late-stage preclinical and product-enabling research that strengthens the foundation for eventual clinical studies.

At its core, RMIP is looking for innovation that directly addresses development and translational challenges for adult stem cell-based products. The emphasis is not on basic discovery, early proof-of-concept, or exploratory biology. Instead, applicants are expected to propose solutions to recognized issues that come up when moving a regenerative medicine concept toward a regulated product: how the product is characterized in depth, how it is manufactured reproducibly, how its potency and identity are defined and measured, how quality is controlled across batches, and how safety is assessed in a way that is meaningful for regulators and clinicians. The announcement highlights areas such as tools, methods, standards, and applied science approaches that improve evaluation of the product itself, including its in vivo function and integration, and the evidence needed to support claims of effectiveness. In other words, NIH is encouraging projects that make regenerative medicine development more measurable, more standardized, and more defensible when it is time to communicate with FDA.

A key theme in the opportunity is regulatory relevance. The program explicitly points applicants toward work that would be useful for regulatory submissions and regulatory decision-making. That includes generating or supplementing evidence needed for clinical development and, specifically, work that supports preparation of an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) submission. The notice also makes clear that NIH will consider late-stage preclinical studies involving adult stem cells when they are framed as the type of research that strengthens an IND/IDE package or adds to the evidence base for studies conducted under an already authorized IND or IDE. This is essentially a bridge-building program: it helps small businesses do the difficult, expensive, and highly technical preclinical and product-development work that often determines whether a regenerative medicine program can realistically move into the clinic.

From an applicant eligibility standpoint, the opportunity is limited to small businesses, consistent with its intent to accelerate commercialization-oriented development work. The eligibility rules also draw a firm boundary around foreign participation: non-U.S. (foreign) institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them in the NIH Grants Policy Statement) are not allowed. Practically, that means the work and the participating entities must stay within an allowable domestic framework, which is a common requirement for certain U.S. government funding programs, particularly those focused on product development and translational pipelines.

On the funding details provided, the award instrument is a cooperative agreement, which generally implies more substantial federal involvement than a standard grant mechanism. While the exact structure can vary by program, cooperative agreements typically involve closer coordination with NIH program staff and potentially more active project stewardship, which fits the program's translational and regulatory focus. The listed award ceiling is $225,000. The original closing date shown is October 19, 2018, and the opportunity was created on August 1, 2018. The opportunity is categorized under discretionary funding and is associated with multiple CFDA numbers spanning various NIH components, reflecting broad NIH participation and the cross-cutting nature of regenerative medicine development.

Overall, RMIP (UT2) is best understood as a targeted, product-enabling regenerative medicine program for small businesses working with adult stem cells, centered on solving the practical technical and standards-related problems that stand between promising science and a regulatory-ready therapeutic product. The strongest fit is a late-stage preclinical or translational development plan that produces rigorous, decision-grade data and/or tools that can be used in an IND/IDE context, without crossing the line into conducting a clinical trial under this specific funding opportunity.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Regenerative Medicine Innovation Projects (RMIP) (UT2 - 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): 93.121, 93.173, 93.233, 93.242, 93.286, 93.350, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.856, 93.866, 93.867.
• This funding opportunity was created on 2018-08-01.
• Applicants must submit their applications by 2018-10-19. (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 $225,000.00 in funding.
• Eligible applicants include: Small businesses.

Apply for RFA HL 18 033

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