Engineering Improved Stem Cell-Derived Islet Cells for Replacement Therapies (R01 - Clinical Trial Not Allowed)

The National Institutes of Health (NIH), specifically the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), has issued a funding opportunity titled “Engineering Improved Stem Cell-Derived Islet Cells for Replacement Therapies (R01 - Clinical Trial Not Allowed).” This grant supports advanced research into engineering intrinsic properties of stem cell-derived islet cell products to enhance their effectiveness in cell replacement therapies, particularly for individuals with type 1 diabetes (T1D). The program leverages the Special Diabetes Program to promote innovative approaches for preventing, treating, and potentially curing T1D by improving the durability, function, and immune resilience of islet cell grafts. Stem cell-derived islet cells offer advantages over cadaveric islets by originating from well-characterized, controlled cell banks, enabling refined manufacturing processes and quality control. These capabilities make it possible to engineer cells with specific traits aimed at enhancing viability and therapeutic impact. The program encourages exploration of novel gene or molecular targets, development of immune evasion techniques, safety switches, and real-time reporting tools embedded within islet cells. Importantly, the funding opportunity excludes projects focused on implant site engineering, co-transplantation scaffolds, encapsulation, or xenogeneic cell sources. Eligible applicants include a wide spectrum of U.S.-based entities such as higher education institutions, nonprofits, state and local governments, tribal organizations, and for-profit businesses, including small businesses. Foreign entities, components, and collaborations involving foreign subcontracts are explicitly ineligible. Applications involving any form of foreign subaward or subcontract will be deemed noncompliant and excluded from review, though limited unfunded foreign collaborations or purchases from foreign vendors are permitted. The funding mechanism is the R01 research project grant, and clinical trials are not allowed. NIH plans to commit $3 million in FY 2026 to support 4–6 awards. Each project may request up to $500,000 in direct costs annually for up to five years. No cost-sharing or matching funds are required. The application process must follow the SF424(R&R) guidelines, with strict conformance to NIH’s data sharing and submission policies. Applications must be submitted electronically via ASSIST, Grants.gov Workspace, or institutional system-to-system solutions. The application cycle opens on February 6, 2026, and submissions are due by March 6, 2026, at 5:00 PM local time. Awards are expected to begin in December 2026 following scientific peer review, advisory council evaluation, and final NIH approval. There is no letter of intent or pre-application step required. The opportunity is issued annually, and the next expected cycle will open in February 2027. For inquiries, applicants may contact Albert Hwa at NIDDK_DEM@nih.gov. A PDF of the full NOFO is not publicly linked but is summarized on Grants.gov under RFA-DK-26-306.

Reviewers prioritize rigor, innovation, and feasibility. Clear data analysis plans, appropriate biological variable inclusion, and strong scientific rationale are critical.