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Therapeutic cells encapsulation and delivery for improved healing of chronic diabetic wounds

Award Number: R43DK115347
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: 09/01/2017
PERIOD OF PERFORMANCE END DATE: 08/31/2021

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Therapeutic cells encapsulation and delivery for improved healing of chronic diabetic wounds - The goal of this Phase I SBIR proposal is to demonstrate feasibility of a flowable, antimicrobial cell delivery vehicle for improving tissue regeneration in clean and pathogen-contaminated diabetic wounds. Diabetic ulcers are a major burden on public health and the economy, as they represent least 33 % of the annual $116 billion in direct diabetic health care cost in the United States. This burden is projected to increase in the near future, since it is estimated that the prevalence of diabetes in the US, which is currently at 9.3%, could reach up to 1 in 3 adults by 2050. Delayed diabetic wound healing complicated by infection is the primary cause of non-traumatic lower-limb amputations, representing ~100,000 cases annually. The proposed product will deliver therapeutic cells into diabetic wounds that are at risk for infection by (i) allowing simple, point-of-care cell encapsulation and application to wound beds (ii) providing an extracellular cell scaffolding matrix that promotes retention and viability of transplanted cells (iii) preventing pathogenic contamination through intrinsic, broad-spectrum antimicrobial activity. The proposed product is intended for use by healthcare professionals following surgical wound debridement procedures. To establish feasibility for this product, we propose the following two specific aims: Specific Aim 1: Evaluate gel formulations for their ability to effectively encapsulate therapeutic cells and support cell viability in vivo. Milestones: Show high viability of therapeutic cells following encapsulation in gels both in vitro and in vivo. Specific Aim 2: Demonstrate in vivo efficacy of gels delivering therapeutic cells for promoting improved healing of full-thickness clean and pathogen-contaminated wounds in diabetic mice. Milestones: Show accelerated wound healing and improved quality of regenerated tissue at days 14 and 28. In Phase II SBIR studies, we will validate the product in a diabetic swine model of wound healing, establish GMP manufacturing, and execute GLP studies in preparation for an FDA pre-submission discussion.


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: 2022 ( Subtotal = $0 )
2022	2017	GEL4MED INC	655 WATERTOWN ST	NEWTONVILLE	MA	02460	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	2/16/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2017	GEL4MED, INC.	15 WAVERLY ST STE 210	BRIGHTON	MA	02135	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	3/3/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2017	GEL4MED, INC.	15 WAVERLY ST STE 210	BRIGHTON	MA	02135	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	7/15/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2017	GEL4MED, INC.	15 WAVERLY ST STE 210	BRIGHTON	MA	02135	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	8/27/2019	NEW	$0
2019	2017	GEL4MED, INC.	15 WAVERLY ST STE 210	BRIGHTON	MA	02135	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	10/25/2018	NEW	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $298,530 )
2017	2017	GEL4MED, INC.	15 WAVERLY ST STE 210	BRIGHTON	MA	02135	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	8/31/2017	NEW	$298,530
														Subtotal = $298,530

Grand Total All Awards = $298,530

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Therapeutic cells encapsulation and delivery for improved healing of chronic diabetic wounds

Award Number: R43DK115347

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: 09/01/2017

PERIOD OF PERFORMANCE END DATE: 08/31/2021

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