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Bioengineered Tissues For Uterine Reconstruction

Award Number: R01HD108298
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/02/2022
PERIOD OF PERFORMANCE END DATE: 01/31/2027

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Bioengineered Tissues For Uterine Reconstruction - Summary Uterine-factor infertility affects up to 8.0% of infertile women, 13.3% of those with a history of miscarriage, 24.5% of those with miscarriage and infertility and 1:500 or 1.5 million women worldwide. The use of human allogeneic uterine tissues is a good option for uterine reconstruction, but its clinical use can be compromised by donor shortage, and immunologic complications. Alternatives are needed. Recently, we reported, in Nature Biotechnology, the application of autologous cell seeded-bioengineered uterine constructs for subtotal organ replacement in a rabbit model. The engineered constructs maintained luminal patency, developed native uterine tissue-like cellular and acellular structure and biomechanical properties; and supported embryo attachment, placentation, pregnancy, and full-term delivery of viable offspring following natural mating. While rabbits provide proof-of principle for this approach, they do not have a simplex uterus or monthly menstrual cyclicity. The most appropriate preclinical model that parallels the uterine structure and function of women are old-world monkeys who have a relatively thick simplex uterus, a monthly menstrual cycle including cycles of growth, differentiation, degeneration (menses), and regeneration during their reproductive life. Recently, we completed a series of tests using bioengineered implants that accommodate the thicker simplex uterus of NHPs and assessed structural maturation; but did not assess the contribution of seeded vs. peripheral cells and matrix production in structural regeneration, or their relationship to native uterine/endometrial biology and function. To this end, the goal of this study is to measure the ability of autologous cell-seeded polymer scaffolds to reproduce primate-like uterine tissue-like structure and function with significant surgically created uterine defects. The approach is to identify the cellular and acellular origin of structural and functional regeneration; thus exploring the biology of the regeneration process in these bioengineered implants. The clinical potential for successful treatment of uterine factor infertility includes repair of adenomyosis/adenomyomas and uterine fibroid resection; restoration of endometrial function in Asherman’s Syndrome; and reconstruction of normal uterine anatomy and function in women with congenital abnormalities. Aim 1 will assess the structural development of the seeded bioengineered implants and test the hypotheses that these implants develop native uterine tissue-like structure and size; consist of both labeled seeded myometrial/endometrial and peripheral cells that contribute cellular and acellular development similar to native tissue. Aim 2 will assess the functional development of bioengineered uterine constructs and will test the hypotheses that they develop biomechanical and contractile properties similar to that of native uteri; and functional endometrial markers consistent with normal uterine receptivity, implantation and pregnancy. These studies will translate the work done in rabbits to a primate model that is highly relevant in structure and physiology to that of women, and help us better understand the underlying biology of a bioengineering approach for treating uterine factor infertility.


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 = $393,277 )
2026	2026	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Child Health and Human Development Extramural Research	001	5	1/29/2026	NON-COMPETING CONTINUATION	$393,277
2026	2025	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Child Health and Human Development Extramural Research	000	4	1/21/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $393,277

Issue Date FY: 2025 ( Subtotal = $404,592 )
2025	2025	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Child Health and Human Development Extramural Research	001	4	4/14/2025	NON-COMPETING CONTINUATION	$40,459
2025	2025	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Child Health and Human Development Extramural Research	000	4	1/13/2025	NON-COMPETING CONTINUATION	$364,133
														Subtotal = $404,592

Issue Date FY: 2024 ( Subtotal = $497,469 )
2024	2024	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Child Health and Human Development Extramural Research	000	3	1/10/2024	NON-COMPETING CONTINUATION	$452,245
2024	2024	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Child Health and Human Development Extramural Research	001	3	5/2/2024	NON-COMPETING CONTINUATION	$45,224
														Subtotal = $497,469

Issue Date FY: 2023 ( Subtotal = $496,936 )
2023	2023	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Child Health and Human Development Extramural Research	000	2	1/23/2023	NON-COMPETING CONTINUATION	$496,936
														Subtotal = $496,936

Issue Date FY: 2022 ( Subtotal = $589,817 )
2022	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Child Health and Human Development Extramural Research	000	1	3/2/2022	NEW	$589,817
														Subtotal = $589,817

Grand Total All Awards = $2,382,091

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Bioengineered Tissues For Uterine Reconstruction

Award Number: R01HD108298

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/02/2022

PERIOD OF PERFORMANCE END DATE: 01/31/2027

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