NIH – Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (T1D) (R01 Clinical Trial Optional)

April 16, 2021 by


This Funding Opportunity Announcement (FOA) encourages applications from institutions/organizations proposing original research addressing barriers that limit progress toward effective cell therapies for type 1 diabetes (T1D). The purpose is to support research leading to the development and testing of novel and supportive technologies for the improvement of cell interventions using novel cell sources, immune-modulatory strategies, biomaterials and devices for T1D treatment.


Despite clear progress made during the last decades on cellular transplantation for T1D, the most recent results demonstrate a long-term limited viability of engrafted islets and, as a result, limited insulin independence under different novel modalities of immunosuppressive (IS) regimens. In addition, even the most innovative IS regimens required for transplant survival still have significant side effects and long-term safety remains uncertain. These problems together with the scarcity of donor organs and the complexity of transplants mandate a renewed emphasis on the investigation of novel methods within the field of cell/tissue engineering for the development of a bio-artificial, cell-based hormone replacement therapy that may minimize, or possibly eliminate the need of IS. To support this, it is necessary to develop/optimize novel/smart/safe biomaterials, scaffolds, bio-matrices and bio-barriers that may protect grafted cells from immune rejection and simultaneously promote appropriate vascularization/innervation with an efficient exchange of nutrients and proper oxygenation to optimize cellular long-term survival and proper function. It is also necessary to investigate methods to use different cell sources including human progenitor cells and derivatives of induced pluripotent stem cells as valid option for cell replacement therapy in combination with or without delivery technologies. Also, further research on the potential use of xenogeneic cells/islets is needed. Recent advances in this field, demonstrate feasibility of these technologies, mainly in pre-clinical (rodent) models of T1D. However, important obstacles remain before long-term preclinical efficacy and safety in non-human primates (NHP) can be effectively translated and clinical feasibility verified in humans.

Key Dates:

Open Date (Earliest Submission Date): September 20, 2021
Letter of Intent Due Date(s): September 20, 2021
Application: October, 20 2021

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Filed Under: Funding Opportunities