Regenerative Medicine Innovation Projects (RMIP) (U44 - Clinical Trial Not Allowed) | RFA HL 18 035

Opportunity Information: Apply for RFA HL 18 035

The Regenerative Medicine Innovation Projects (RMIP) funding opportunity (RFA HL 18 035) is a National Institutes of Health (NIH) cooperative agreement designed to help small businesses tackle practical, well-known bottlenecks that slow down or complicate the development of regenerative medicine products based on adult stem cells. It is specifically a U44 mechanism, meaning it is a cooperative agreement rather than a standard grant, and applicants should expect a more hands-on partnership style with the NIH (and coordination with the U.S. Food and Drug Administration) compared with typical research awards. The program is aimed at moving regenerative medicine technologies closer to readiness for regulatory review and eventual clinical use, while explicitly stating that clinical trials are not allowed under this opportunity.

The core purpose of the program is to support innovative, solutions-oriented projects that strengthen the evidence package needed for product development and regulatory submissions. NIH is looking for work that improves how adult stem cell-based products are characterized, manufactured, tested, and validated, especially in ways that regulators and developers rely on when deciding whether a product is consistent, safe, and likely to work. The emphasis is not simply on scientific discovery, but on applied development efforts that address real translational problems that repeatedly come up when trying to turn a regenerative medicine concept into a regulated therapeutic product.

The scope strongly favors projects that address “critical issues” for regulatory submission and product development. Examples of the kinds of topics highlighted include improved tools, methods, standards, and other applied science approaches that enable deeper and more reliable evaluation of product attributes. This includes in-depth product characterization (understanding what the product is and how it behaves), manufacturing and process development (how it is produced consistently and at appropriate quality), potency (demonstrating the product has a measurable biological activity relevant to its intended therapeutic effect), identity (confirming the product is what it is claimed to be), quality and safety (reducing variability and uncovering risks), and functional evaluation such as in vivo function and integration (how the product performs and incorporates in living systems). It also includes work that supports or improves evaluation of effectiveness in a preclinical setting, with the understanding that this is about building credible development data rather than conducting human efficacy trials.

A key feature of RMIP is its interest in late-stage preclinical research involving adult stem cells when that research is intended to generate or supplement evidence for clinical development. The opportunity explicitly mentions that studies may be conducted to support, among other goals, preparation of an Investigational New Drug (IND) application or an Investigational New Device Exemption (IDE) package. It also allows for research that supports work already being conducted under an authorized IND or IDE, as long as the proposed activities themselves remain preclinical and do not cross into clinical trial territory. In practice, this positions the program as a bridge between earlier R&D and the point where a company is ready to engage regulators with a well-supported submission package.

Eligibility is limited to small businesses, consistent with the small business research focus of the U44 mechanism. Foreign participation is tightly restricted: non-U.S. (non-domestic) entities are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components as defined by the NIH Grants Policy Statement are not allowed. In other words, applicants need to be U.S.-based small businesses and plan to conduct the funded work without foreign components.

Administratively, the opportunity is categorized as discretionary funding and falls under health-related activity categories, with multiple CFDA numbers listed (reflecting participation across NIH Institutes and Centers). The original closing date shown is October 19, 2018, indicating this specific announcement was time-bound to that cycle. The award ceiling shown is $225,000, which suggests the program anticipated modest, targeted development efforts aimed at resolving specific translational or regulatory-relevant hurdles rather than underwriting broad platform development or large-scale preclinical programs.

Overall, RMIP is best understood as a targeted NIH-and-FDA-aligned push to improve the development toolkit for adult stem cell-based regenerative medicine products. Competitive applications would be expected to propose a clear, practical solution to a recognized development problem, show how the work will improve the ability to characterize and manufacture a product or to demonstrate potency, identity, safety, and function, and explain how the resulting data or methods will strengthen an eventual IND/IDE-oriented regulatory package without involving any clinical trial activities.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Regenerative Medicine Innovation Projects (RMIP) (U44 - 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 18 035

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