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 17 030

Opportunity Information: Apply for RFA DK 17 030

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) Funding Opportunity Announcement (FOA) that supports Small Business Innovation Research (SBIR) projects aimed at improving cell replacement approaches for treating type 1 diabetes (T1D). The central focus is on advancing practical, engineering-driven solutions that make cell replacement therapies more effective, more durable, and more clinically viable, particularly through the development of new biomaterials and device-based technologies that can support transplanted insulin-producing cells.

This FOA is offered as a discretionary grant under the SBIR program using the R43/R44 mechanisms, which correspond to the standard SBIR phased structure. In general terms, R43 typically supports early feasibility and proof-of-concept work (Phase I), while R44 supports more advanced research and development steps that move a technology closer to commercialization (Phase II). A key limitation is built into the title: clinical trials are not allowed under this announcement. That means the work is intended to remain in the preclinical and technology-development space, such as creating prototypes, optimizing biomaterials, improving device performance, demonstrating function in relevant laboratory and animal models, validating manufacturing approaches, or generating data that de-risks the path toward later-stage clinical evaluation under a different funding or regulatory strategy.

Scientifically, the opportunity targets "novel and supportive technologies" for cell replacement interventions in T1D, with an emphasis on bioengineering innovations. This can include, for example, new encapsulation materials that protect transplanted cells from immune attack, implantable devices that improve oxygen and nutrient delivery to transplanted islets or stem-cell-derived beta cells, scaffolds or matrices that enhance cell survival and function, and other engineered platforms that address common barriers like fibrosis, inflammation, inadequate vascularization, or long-term stability of graft function. The description indicates that NIH is looking for technologies that directly improve the performance and feasibility of cell-based therapies, rather than purely basic biology studies. The overall intent is to help small businesses build enabling tools and translational solutions that can strengthen the entire cell replacement pipeline for T1D.

Eligibility is narrowly defined around U.S. small businesses, consistent with SBIR requirements. The FOA explicitly states that non-domestic (non-U.S.) entities, including foreign institutions, are not eligible to apply, and that non-domestic components of U.S. organizations are also not eligible. However, it also notes that "foreign components," as defined by the NIH Grants Policy Statement, may be allowed in some circumstances. In practice, this typically means a U.S. small business may be able to include certain discrete project elements performed outside the U.S. if they meet NIH rules, are well justified, and are permitted under the specific terms of the announcement, but the applicant organization itself must be an eligible U.S. small business and the project cannot be structured around a non-U.S. operating component as an integral part of the applicant organization.

From an administrative standpoint, the opportunity is issued by the National Institutes of Health and is associated with the program number RFA-DK-17-030, with a CFDA listing of 93.847. The activity categories include health and food/nutrition-related research, aligning with diabetes as a major chronic disease area. The original closing date shown is March 21, 2018, and the FOA creation date is December 21, 2017, which places it as a time-bound solicitation that was active during that period. The summary data provided does not specify an award ceiling or the expected number of awards, so those details would normally need to be confirmed in the full announcement text.

Overall, this NIH SBIR funding opportunity is designed to help U.S. small businesses develop and de-risk next-generation biomaterials and device technologies that can make T1D cell replacement therapies more reliable and clinically practical, while staying strictly in the non-clinical-trial domain. It is best suited for companies building tangible translational platforms such as implantable devices, encapsulation systems, engineered scaffolds, or other enabling bioengineering solutions that address immune protection, cell survival, integration with the host environment, and long-term function of transplanted insulin-producing cells.

• 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 2017-12-21.
• Applicants must submit their applications by 2018-03-21. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

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