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Developing extracellular vesicle based therapeutics against pre-term birth through the use of maternal-fetal interface on a chip

Award Number: UG3TR003283
ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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ABSTRACT Spontaneous preterm birth (PTB) accounts for ~60% of all preterm births (15 million PTBs/year and 1 million neonatal deaths around the globe). Balanced immune homeostasis by fetal and maternal compartments ensure pregnancy maintenance and feto-placental growth. Premature disruption of immune homeostasis and overwhelming host inflammatory response due to infectious or other non-infectious risk factors lead to majority of PTBs. PTB rate has not declined in the past several decades, and current PTB prevention strategies do not address fetal immune responses, a key mediator that triggers preterm labor. The proposing team has recently used an innovative technology to engineer exosomes to be enriched with an inhibitor to NF-¿B, termed as super repressor I¿Ba [SR]. Pilot studies using a transgenic mouse model showed successful delay in PTB without any side effects that was associated with reduction in inflammation at the feto-maternal interface tissues (F-M; fetal membrane cells and maternal decidua). However, moving this to the next stage is challenging, as a very large number of non-human primates, the animal model that most closely resemble the human F-M interface, will be needed, which is cost prohibitive. An organ-on-chip (OOC) model that faithfully represents the structure, functions, and responses of human F-M interface can overcome such challenges. The proposing team has recently reported the first F-M interface OOC model, which was successfully utilized to show the interactive and transitional properties of primary cells, resembling their biological functions in utero. In the UG3 phase, this model will be expanded to include the full F-M interface, recreate a healthy and disease inflammatory state, and fully validated for their cellular functions and responses predisposing to PTB. The UG3 aims are: Aim 1 To validate the F-M interface OOC model; Aim 2 To establish disease F-M interface OOC models. The UH3 aims are: Aim 3 To test extracellular vesicle (EV)-encoded experimental drug NF-kB repressor (SR) on normal and disease F-M interface OOC models; Aim 4 Conduct pre-clinical trial using the OOC model to investigate the impact of racial diversity and gender of fetus on the efficacy of the experimental drug. The success of the proposed research will produce a personalized F-M interface OOC model that can mimic either healthy or disease state of pregnancy, which can be used to test the effect of candidate therapeutic molecules to expedite processes towards clinical trials and or eliminate/minimize certain steps from expensive clinical trials.


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: 2024 ( Subtotal = -$1,028 )
2024	2021	TEXAS A&M ENGINEERING EXPERIMENT STATION	3124 TAMU	COLLEGE STATION	TX	77843	BRAZOS	USA	National Center for Advancing Translational Sciences	000	2	12/12/2023	NON-COMPETING CONTINUATION	-$928
2024	2021	TEXAS A&M ENGINEERING EXPERIMENT STATION	3124 TAMU	COLLEGE STATION	TX	77843	BRAZOS	USA	National Center for Advancing Translational Sciences	001	2	12/12/2023	SUPPLEMENT FOR EXPANSION	-$100
														Subtotal = -$1,028

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	TEXAS A&M ENGINEERING EXPERIMENT STATION	3124 TAMU	COLLEGE STATION	TX	77843	BRAZOS	USA	National Center for Advancing Translational Sciences	000	2	6/24/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $800,851 )
2021	2021	TEXAS A&M ENGINEERING EXPERIMENT STATION	7607 EASTMARK DR	COLLEGE STATION	TX	77840	BRAZOS	USA	National Center for Advancing Translational Sciences	000	2	7/27/2021	NON-COMPETING CONTINUATION	$722,985
2021	2021	TEXAS A&M ENGINEERING EXPERIMENT STATION	7607 EASTMARK DR	COLLEGE STATION	TX	77840	BRAZOS	USA	National Center for Advancing Translational Sciences	001	2	8/25/2021	SUPPLEMENT FOR EXPANSION	$77,866
														Subtotal = $800,851

Issue Date FY: 2020 ( Subtotal = $691,020 )
2020	2020	TEXAS A&M ENGINEERING EXPERIMENT STATION	7607 EASTMARK DR	COLLEGE STATION	TX	77840	BRAZOS	USA	National Center for Advancing Translational Sciences	000	1	8/26/2020	NEW	$691,020
														Subtotal = $691,020

Grand Total All Awards = $1,490,843

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Developing extracellular vesicle based therapeutics against pre-term birth through the use of maternal-fetal interface on a chip

Award Number: UG3TR003283

ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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