Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (R43/44 Clinical Trial Not Allowed) | RFA DK 18 023

Opportunity Information: Apply for RFA DK 18 023

The grant opportunity titled "Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (R43/44 Clinical Trial Not Allowed)" is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding announcement focused on accelerating practical, technology-driven advances that can make cell replacement therapies for type 1 diabetes (T1D) work better. It supports research and development aimed at creating new or improved tools, platforms, biomaterials, and devices that address key bottlenecks in replacing insulin-producing cells, with an emphasis on engineering and translational solutions rather than basic discovery alone. As indicated by the R43/R44 mechanism, the program is structured for small businesses and typically aligns with phased SBIR development, moving from early feasibility and proof-of-concept work toward more advanced development and validation as the project matures.

The scientific goal of the announcement is to improve cell replacement interventions for T1D by advancing "novel and supportive technologies." In practical terms, this points to efforts that can enhance the survival, function, and long-term performance of transplanted or implanted insulin-producing cells, as well as the methods used to deliver and protect those cells in the body. The description highlights technologies that involve novel methods, biomaterials, and devices. That framing strongly suggests interest in bioengineering approaches such as advanced cell encapsulation or immunoprotective barriers, implantable devices that improve oxygenation and nutrient transport, scaffolds or matrices that promote cell engraftment, improved manufacturing and handling approaches that preserve cell quality, and other enabling technologies that make cell replacement more reliable, durable, and scalable. The announcement is oriented toward product-enabling R and D that a small business could ultimately translate into a deployable technology supporting T1D cell therapy strategies.

This FOA is explicitly marked "Clinical Trial Not Allowed," meaning applicants are not permitted to propose or conduct clinical trials under this specific funding opportunity. Projects can still be translational and may involve preclinical development and testing, but the work must stop short of clinical trial activities as defined by NIH policy. In effect, the program supports the kind of preclinical engineering, prototyping, optimization, and validation work needed to de-risk a technology so it could later move toward clinical evaluation under other mechanisms or funding opportunities.

Eligibility is limited to small businesses, consistent with SBIR requirements. Non-domestic (non-U.S.) entities, including foreign institutions, are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply as part of the applicant organization. However, the announcement notes that "foreign components" may be allowed as defined by the NIH Grants Policy Statement, which generally refers to discrete project elements performed outside the United States under specific justifications and approvals. The practical takeaway is that the applicant organization must be an eligible U.S. small business, and any foreign involvement would need to be handled, justified, and structured in a way consistent with NIH foreign component rules rather than as a foreign applicant or a non-U.S. organizational component.

From an administrative standpoint, the opportunity is a discretionary grant under the NIH, listed under CFDA 93.847, and categorized under health-related research activities (also tagged under food and nutrition, health). The funding opportunity number is RFA-DK-18-023, and the original closing date listed is March 21, 2019, with a creation date of January 18, 2019. The source data does not provide an award ceiling or the expected number of awards, so the precise funding size and award count are not specified in the provided excerpt and would normally be confirmed in the full FOA text on NIH systems.

Overall, this program was designed to push forward enabling bioengineering technologies that can strengthen the real-world feasibility of cell replacement therapies for type 1 diabetes, with SBIR-style emphasis on innovation, development milestones, and potential commercialization pathways, while keeping the scope firmly in the preclinical or non-clinical-trial domain.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (R43/44 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): 93.847.
• This funding opportunity was created on 2019-01-18.
• Applicants must submit their applications by 2019-03-21. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for RFA DK 18 023

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