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Conformal islet encapsulation for transplantation at vascularized sites to allow physiological insulin secretion

Award Number: R01DK109929
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: 07/05/2016
PERIOD OF PERFORMANCE END DATE: 02/28/2029

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Conformal islet encapsulation for transplantation at vascularized sites to allow physiological insulin secretion - Project Summary: Type 1 diabetes is an autoimmune disease that leads to selective destruction of insulin-secreting pancreatic b cells and lifelong dependence on exogenous insulin supplementation. In the United States, type 1 diabetes affects 1.84 million people, increased 21% in diagnosis between 2001 and 2009, and is projected to affect 5 million people by 2050. Allogeneic b cell replacement through intrahepatic islet transplantation leads to improved metabolic control, quality of life, and decreased levels of long-term complications in patients with type 1 diabetes compared to exogenous insulin supplementation. This is largely due to the capability of transplanted islets to re- establish physiological glucose-stimulated insulin secretion. Recent clinical advances in islet transplantation have increased the hope of the millions of patients with type 1 diabetes for a widely available cure. However, all this progress notwithstanding, the need for chronic systemic immunosuppression to prevent allorejection and recurrence of autoimmunity is still restricting the applicability of b cell replacement procedures only to the most severe cases of type 1 diabetes due to the multitude of unavoidable side effects. Islet immunoisolation through encapsulation with permselective biomaterials is a viable option to allow safer and more widely applicable b cell replacement for patients with type 1 diabetes. The main challenges associated with transplantation of encapsulated islets are (1) their large capsule size, which delays glucose sensing and insulin release and results in an inability to achieve the same level of metabolic control as that provided by unencapsulated islets, and (2) their large graft volumes, which prevent transplantation in retrievable, confined, and well-vascularized sites. We developed an innovative microencapsulation platform that achieves conformal coating of islets, including ones derived from stem cells, within biocompatible, stable, and clinically applicable hydrogels that are only 10-20 µm thick. This conformal coating addresses limitations of traditional islet encapsulation platforms and safety as demonstrated in non-human primate models of type 1 diabetes. However, conformally coated grafts are still hindered by alloreactive T cell activation by alloantigen shedding through permeable hydrogel capsules and can benefit from localized immunomodulatory therapies to improve their performance for clinical translation. Thus, we propose to co-transplant them with our innovative nanomaterial platform to achieve targeted and sustained release of drugs that decrease alloreactive T cell activation in the site of transplantation (aim 1). As an alternative and innovative approach, we also propose to integrate islet conformal coating with co-delivery of tolerogenic stromal cells that can present shed alloantigens to specific T cells, thereby inducing anergy and deletion in the transplant site (aim 2). We will test these combination therapies in murine and rat islet allograft models of type 1 diabetes in clinically applicable confined sites, uniquely enabled by the small volumes of conformal coated grafts in aims 1 and 2. In aim 3, we will test the most promising immunomodulatory approach in non-human primate islet allograft models and with human islets in a humanized mouse model.


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: 2026 ( Subtotal = $503,346 )
2026	2026	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	2/27/2026	NON-COMPETING CONTINUATION	$503,346
														Subtotal = $503,346

Issue Date FY: 2025 ( Subtotal = $503,345 )
2025	2025	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	7	2/14/2025	NON-COMPETING CONTINUATION	$453,011
2025	2025	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	7	6/12/2025	NON-COMPETING CONTINUATION	$50,334
2025	2022	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	1/14/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $503,345

Issue Date FY: 2024 ( Subtotal = $520,751 )
2024	2024	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	6	3/22/2024	COMPETING CONTINUATION	$520,751
														Subtotal = $520,751

Issue Date FY: 2022 ( Subtotal = $457,744 )
2022	2022	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	11/4/2021	NON-COMPETING CONTINUATION	$411,969
2022	2022	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	4/6/2022	NON-COMPETING CONTINUATION	$45,775
														Subtotal = $457,744

Issue Date FY: 2021 ( Subtotal = $464,757 )
2021	2021	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	2/5/2021	NON-COMPETING CONTINUATION	$46,476
2021	2021	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	11/30/2020	NON-COMPETING CONTINUATION	$418,281
														Subtotal = $464,757

Issue Date FY: 2020 ( Subtotal = $472,208 )
2020	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	11/25/2019	NON-COMPETING CONTINUATION	$424,987
2020	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	2/10/2020	NON-COMPETING CONTINUATION	$47,221
														Subtotal = $472,208

Issue Date FY: 2019 ( Subtotal = $479,742 )
2019	2019	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	11/29/2018	NON-COMPETING CONTINUATION	$479,742
														Subtotal = $479,742

Issue Date FY: 2018 ( Subtotal = $487,066 )
2018	2018	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	12/11/2017	NEW	$487,066
														Subtotal = $487,066

Grand Total All Awards = $3,888,959

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Conformal islet encapsulation for transplantation at vascularized sites to allow physiological insulin secretion

Award Number: R01DK109929

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: 07/05/2016

PERIOD OF PERFORMANCE END DATE: 02/28/2029

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