Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (T1D) (R01 Clinical Trial Optional) | RFA DK 18 004

Opportunity Information: Apply for RFA DK 18 004

The grant opportunity titled "Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (T1D) (R01 Clinical Trial Optional)" (Funding Opportunity Number RFA-DK-18-004) is a discretionary NIH research grant aimed at pushing forward practical, effective cell replacement approaches for people with type 1 diabetes. The central focus is not simply on studying diabetes biology in general, but on solving the real technical and translational obstacles that have slowed progress in making cell replacement therapies work reliably, safely, and durably in patients. The FOA is positioned within NIH's health and nutrition research mission (CFDA 93.847) and supports original research projects that can generate new enabling tools, engineering strategies, and proof-of-concept testing that move the field closer to clinical impact.

A key theme of the announcement is technology development for cell replacement interventions, especially the kinds of bioengineering advances needed to make transplanted insulin-producing cells survive, function, and remain protected over time. The FOA explicitly emphasizes novel biomaterials and devices, which commonly includes areas like immunoprotective encapsulation, implantable or retrievable devices, scaffolds that improve cell survival and vascularization, materials that reduce fibrosis or inflammatory responses, and systems that improve oxygen and nutrient delivery to implanted cells. In practical terms, the NIH is signaling interest in proposals that tackle barriers such as immune rejection, foreign-body reactions to implanted materials, inadequate engraftment, poor long-term viability of replacement cells, limited control over where cells reside in the body, and difficulties with monitoring or retrieving implants if complications occur. The intent is to fund research that does not just describe these challenges, but produces concrete technological solutions and tests them in ways that demonstrate feasibility for improving T1D cell replacement therapies.

The mechanism is an R01, meaning it is designed for substantial, hypothesis-driven or technology-driven research programs with enough scope to develop and evaluate new approaches. The "Clinical Trial Optional" designation indicates that applicants may propose studies that include a clinical trial if appropriate, but they are not required to do so. This accommodates both preclinical development (for example, device and biomaterial prototyping and testing in relevant models) and more advanced translational work that could involve human participants, depending on readiness and the nature of the proposed technology.

Eligibility is broad and includes a wide range of U.S. and non-U.S. organizations. Standard eligible applicants listed include state, county, city or township 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 that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those specific nonprofit categories); for-profit organizations (other than small businesses); and small businesses. The FOA also calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and foreign (non-U.S.) entities. The overall message is that NIH is open to strong, well-justified proposals from many sectors, including academic, nonprofit, industry, and international groups, as long as they can meaningfully address the stated technological barriers.

Administrative details in the source information indicate the opportunity was created on February 15, 2018, with an original closing date of May 10, 2018. The award ceiling is listed as $500,000, which signals an upper bound for annual or total costs depending on NIH-specific budget interpretation in the full FOA, and an emphasis on focused but impactful engineering and translational work. The number of expected awards is not specified in the provided excerpt, which is common when the agency intends to fund based on the quality of applications and available appropriations rather than committing to a fixed number upfront.

Overall, this FOA is best understood as a targeted NIH call for bioengineering and technology innovation that can unlock the next generation of T1D cell replacement therapies. Rather than funding broad exploratory diabetes research, it prioritizes solutions-oriented projects that develop and test biomaterials, devices, and supportive technologies that directly improve the performance, safety, and practicality of replacing lost insulin-producing cell function in type 1 diabetes.

• 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 (T1D) (R01 Clinical Trial Optional)" 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 2018-02-15.
• Applicants must submit their applications by 2018-05-10. (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 $500,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA DK 18 004

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: