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SMART Polymer Fibers For Tampon-Like Nonsteroidal Contraceptive Devices

Award Number: R33HD099748
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: 09/13/2019
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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SMART Polymer Fibers For Tampon-Like Nonsteroidal Contraceptive Devices - PROJECT SUMMARY/ABSTRACT Natural fertility requires spermatozoa to migrate through viscoelastic secretions and to overcome the physiolog- ical acidic environment of the female reproductive tract. Our preliminary data show that novel mucoadhesive, bioresponsive polymer compositions maintain a physiologically acidic pH environment upon exposure to seminal fluid and, at the same time, dramatically increase viscoelastic properties, which negatively impacts sperm motil- ity. Therefore, it is hypothesized that - upon exposure to semen - the novel mucoadhesive, bioresponsive com- position rapidly transforms the vaginal cavity into an inhospitable environment for sperm. We propose to explore an innovative approach to on-demand non-steroidal contraception for women using SMART (= System Mute until Activation by a Remote Trigger) polymer fibers that maintain a physiological, protective vag- inal environment upon exposure to seminal fluid resulting in infertility. This high-risk/high-reward research strategy is fundamentally different from conventional nonsteroidal contraceptive methods as it represents an innovative bioengineering concept intended to reach the human testing phase (i.e., IND milestone) much faster and at a lower cost than conventional development programs focusing on medicinal chemistry approaches. In the R61 Phase, we will test whether non-woven fiber mats comprised of bioresponsive polymer mixtures establish an acidic mucoadhesive gel phase upon exposure to vaginal fluid that maintains a physiologically pro- tective highly viscous, acidic milieu in the presence of semen, thereby inhibiting sperm motility to a level con- sistent with infertility. The feasibility of this approach has been shown using polymeric fiber mats produced by electrospinning that demonstrated rapid conversion into a gel phase, which maintained acidic properties upon exposure to alkaline seminal fluid while, simultaneously, increasing 5-fold in viscosity. In Aim #1, we will delineate electrospinning fabrication parameters required to prepare dry, non-woven fiber mats that exhibit desired muco- adhesive and bioresponsive properties. We will test their ability to rapidly reconstitute into an acidic gel phase and maintain effective physical and chemical barriers properties for human sperm that are consistent with infer- tility. In Aim #2, we will define safety risks of non-woven polymeric fiber mats for nonsteroidal contraception. We will assess whether polymeric fiber mats are toxic to cells of the female reproductive tract. In addition, we will explore human factors that contribute to use-related safety and efficacy risks using internet surveys. The R33 Phase will be initiated only if quantitative milestones defined for the R61 Phase are met. In Aim #3, we will refine electrospinning fabrication process and perform a more rigorous in vitro safety assessment that includes inter- actions with the vaginal microbiome. In the final Aim #4, we will determine the safety, tolerability, and contracep- tive efficacy of the most promising polymer composition in vivo using the rabbit animal 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 = -$140,904 )
2026	2023	UNIVERSITY OF HEALTH SCIENCES AND PHARMACY IN ST. LOUIS	1 PHARMACY PL	SAINT LOUIS	MO	63110	SAINT LOUIS CITY	USA	Child Health and Human Development Extramural Research	000	5	2/26/2026	NON-COMPETING CONTINUATION	-$140,904
														Subtotal = -$140,904

Issue Date FY: 2023 ( Subtotal = $818,526 )
2023	2023	UNIVERSITY OF HEALTH SCIENCES AND PHARMACY IN ST. LOUIS	1 PHARMACY PL	SAINT LOUIS	MO	63110	SAINT LOUIS CITY	USA	Child Health and Human Development Extramural Research	001	5	8/9/2023	SUPPLEMENT FOR EXPANSION	$109,174
2023	2023	UNIVERSITY OF HEALTH SCIENCES AND PHARMACY IN ST. LOUIS	1 PHARMACY PL	SAINT LOUIS	MO	63110	SAINT LOUIS CITY	USA	Child Health and Human Development Extramural Research	000	5	8/8/2023	NON-COMPETING CONTINUATION	$709,352
														Subtotal = $818,526

Issue Date FY: 2022 ( Subtotal = $1,021,013 )
2022	2022	UNIVERSITY OF HEALTH SCIENCES AND PHARMACY IN ST. LOUIS	1 PHARMACY PL	SAINT LOUIS	MO	63110	SAINT LOUIS CITY	USA	Child Health and Human Development Extramural Research	001	4	8/23/2022	NON-COMPETING CONTINUATION	$804,143
2022	2021	UNIVERSITY OF HEALTH SCIENCES AND PHARMACY IN ST. LOUIS	1 PHARMACY PL	SAINT LOUIS	MO	63110	SAINT LOUIS CITY	USA	Child Health and Human Development Extramural Research	000	3	5/9/2022	EXTENSION WITH OR WITHOUT FUNDS	$216,870
														Subtotal = $1,021,013

Issue Date FY: 2021 ( Subtotal = $754,905 )
2021	2021	UNIVERSITY OF HEALTH SCIENCES AND PHARMACY IN ST. LOUIS	4588 PARKVIEW PL	SAINT LOUIS	MO	63110	SAINT LOUIS CITY	USA	Child Health and Human Development Extramural Research	000	3	8/24/2021	EXTENSION WITH OR WITHOUT FUNDS	$754,905
														Subtotal = $754,905

Grand Total All Awards = $2,453,540

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SMART Polymer Fibers For Tampon-Like Nonsteroidal Contraceptive Devices

Award Number: R33HD099748

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: 09/13/2019

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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