Wednesday, July 2, 2025 7/2/2025

Hydrogels for human beta cell survival, function and evasion of immune rejection

Award Number: R01DK133702
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2022
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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Hydrogels for human beta cell survival, function and evasion of immune rejection - PROJECT SUMMARY Type 1 diabetes (T1D) is an autoimmune disease in which the insulin-producing β-cells of the pancreas are destroyed. T1D affects 3 million children and adults in the US with healthcare costs exceeding $15 billion. Standard therapy with exogenous insulin is burdensome, associated with a significant danger of hypoglycemia, and only partially efficacious in preventing long-term complications. Transplantation of allogeneic islets from cadaveric donors in conjunction with chronic immunosuppression has been recently shown to be effective in restoring euglycemia in clinical trials. However, the long-term future of cell replacement therapy for T1D requires a reliable and replenishable β-cell source and elimination of the need for chronic immunosuppression. β-cells derived from human pluripotent stem cells (SC-β cells) represent a transformative, unlimited source of insulin- producing cells for the treatment of T1D. Despite advances in engineering functional insulin-producing SC-β cells, significant barriers related to long-term engraftment and function without chronic immunosuppression hinder the clinical translation of these promising cells. Furthermore, the use of encapsulation devices to protect transplanted cells has not been successful in large animal models due to fibrotic responses and lack of direct vascularization. Our objective is to engineer advanced biomaterial delivery technologies to (i) enhance vascularization, survival, and engraftment of SC-β cells and (ii) protect them from rejection by the immune system without the need for encapsulation or chronic immunosuppression. We hypothesize that synthetic hydrogels with controlled presentation of vasculogenic and immunomodulatory signals will provide an injectable delivery vehicle that directs SC-β cell survival, engraftment, and function without chronic immunosuppression or encapsulation. Aim 1: Engineer injectable VEGF-delivering hydrogels to promote vascularization, survival, and function of SC- β cells transplanted in the subcutaneous space of diabetic, immunocompromised mice. Aim 2: Evaluate our SA- FasL-microgel technology to promote SC-β cell immune acceptance and function in diabetic, immunocompetent humanized mice without chronic immunosuppression. Aim 3: Examine the ability of VEGF/SA-FasL hydrogels to enhance SC-β cell survival and function in diabetic nonhuman primates with no or reduced chronic immunosuppression in a pilot study. This highly significant and innovative strategy is fundamentally different from ongoing work in the field in terms of engineering advanced injectable biomaterials that promote SC-β cell vascularization, local immune acceptance, survival, and function without encapsulation in devices or systemic immunosuppression. Furthermore, the focus on humanized murine and nonhuman primate models will accelerate the development of an effective and broadly applicable cure for T1D.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $784,733 )
2025	2025	GEORGIA TECH RESEARCH CORP	926 DALNEY ST NW	ATLANTA	GA	30318	FULTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	5/28/2025	NON-COMPETING CONTINUATION	$784,733
														Subtotal = $784,733

Issue Date FY: 2024 ( Subtotal = $868,391 )
2024	2024	GEORGIA TECH RESEARCH CORP	926 DALNEY ST NW	ATLANTA	GA	30318	FULTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	5/13/2024	NON-COMPETING CONTINUATION	$785,689
2024	2024	GEORGIA TECH RESEARCH CORP	926 DALNEY ST NW	ATLANTA	GA	30318	FULTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	3	5/14/2024	SUPPLEMENT FOR EXPANSION	$82,702
2024	2023	GEORGIA TECH RESEARCH CORPORATION	926 DALNEY ST NW	ATLANTA	GA	30332	FULTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	2/1/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $868,391

Issue Date FY: 2023 ( Subtotal = $855,573 )
2023	2023	GEORGIA TECH RESEARCH CORPORATION	926 DALNEY ST NW	ATLANTA	GA	30332	FULTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	7/13/2023	SUPPLEMENT FOR EXPANSION	$82,702
2023	2023	GEORGIA TECH RESEARCH CORPORATION	926 DALNEY ST NW	ATLANTA	GA	30332	FULTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	6/9/2023	NON-COMPETING CONTINUATION	$772,871
														Subtotal = $855,573

Issue Date FY: 2022 ( Subtotal = $822,338 )
2022	2022	GEORGIA TECH RESEARCH CORPORATION	926 DALNEY ST NW	ATLANTA	GA	30332	FULTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/15/2022	NEW	$822,338
														Subtotal = $822,338

Grand Total All Awards = $3,331,035

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Hydrogels for human beta cell survival, function and evasion of immune rejection

Award Number: R01DK133702

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2022

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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