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

This funding opportunity is designed to support research in understanding how to engineer intrinsic characteristics of stem cell-derived islet cell products that can result in improved cell replacement therapy outcomes. Unlike cadaveric human islets, stem cell-derived islet cell products are generated from well-defined and highly controlled cell bank sources. Their banking, manufacturing, and quality control processes can be used to instill optimized cell characteristics resulting in more resilient and durable graft viability and function. This funding opportunity aims to stimulate studies on targets and pathways amenable to such engineering approaches and to encourage preclinical testing and validation of such strategies.This NOFO is associated with the Special Diabetes Program (https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/type-1-diabetes-special-statutory-funding-program/about-special-diabetes-program) which funds research on the prevention, treatment, and cure of type 1 diabetes and its complications, including unique, innovative, and collaborative research consortia and clinical trials networks.

This funding opportunity is designed to support research in understanding how to engineer intrinsic characteristics of stem cell-derived islet cell products that can result in improved cell replacement therapy outcomes. Unlike cadaveric human islets, stem cell-derived islet cell products are generated from well-defined and highly controlled cell bank sources. Their banking, manufacturing, and quality control processes can be used to instill optimized cell characteristics resulting in more resilient and durable graft viability and function. This funding opportunity aims to stimulate studies on targets and pathways amenable to such engineering approaches and to encourage preclinical testing and validation of such strategies.This NOFO is associated with the Special Diabetes Program (https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/type-1-diabetes-special-statutory-funding-program/about-special-diabetes-program) which funds research on the prevention, treatment, and cure of type 1 diabetes and its complications, including unique, innovative, and collaborative research consortia and clinical trials networks.

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.