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Evaluation of growth potential of ice-free vitrified heart valves in a pediatric porcine model.

Award Number: R41HL169059
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2023
PERIOD OF PERFORMANCE END DATE: 09/30/2025

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Evaluation of growth potential of ice-free vitrified heart valves in a pediatric porcine model. - Abstract: Heart valve replacement in children is a serious problem because there are no heart valve implants that grow with the patient. The valves that are currently employed need to be changed as the patient grows with a very high associated mortality rate (~40%). In response to this clinical need, we are pioneering an entirely new approach to deliver growing heart valve implants, which we are calling partial heart transplantation (PHT). PHT differs from heart transplantation because only the part of the heart containing a valve is transplanted. Based on our preliminary data in immunosuppressed piglets, we recently performed the world’s first human partial heart transplant on 4/22/2022 with demonstrated valve growth. However, the chance of a donor partial heart transplant being available at just the right time is low. Therefore, we propose development of a network of tissue banks with technology licenses at major pediatric cardiovascular medical centers nationwide in preparation for clinical application. Our central hypothesis is that vitrified and nanowarmed PHTs can fulfill both their hemodynamic and biological functions after orthotopic transplantation in growing children. In this Phase I proposal there are three specific aims: First we propose optimization of short-term preservation protocols. Our working hypothesis for this aim is that PHTs will tolerate longer post-mortem cold ischemic times than intact hearts. The impact of procurement and refrigeration on piglet-derived PHTs will be evaluated by assessment of viability in vitro. This will establish the anticipated geographic range for PHT procurement after dissection based upon estimated refrigerated travel time. In the second specific aim we will optimize vitrification protocols for PHTs. Our working hypothesis for this aim is that ice-free cryo-preservation employing tissue vitrification, rapid nanowarming and apoptosis inhibition developed for adult porcine pulmonary heart valves can be further optimized for smaller PHTs required for pediatric cases. Different cryoprotectant loading times, exposure conditions, and apoptosis inhibitors will be evaluated by assessment of viability in vitro. This will establish the optimal vitrification protocol for pediatric PHTs. In the final aim we will evaluate post- transplant growth, leaflet viability and hemodynamic function of optimally vitrified and nanowarmed cryopreserved PHTs. Our working hypothesis for this aim is that optimized protocols will allow vitrified PHTs that were banked for one month to function in vivo like fresh PHTs. The optimized protocols developed in the earlier aims will be evaluated in a swine leukocyte antigen matched growing immunosuppressed piglet PHT model by transplantation. This will establish the PHT vitrification, warming, and banking methods for future clinical application.


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 = $0 )
2026	2023	TISSUE TESTING TECHNOLOGIES LLC	2231 TECHNICAL PKWY	CHARLESTON	SC	29406	CHARLESTON	USA	Cardiovascular Diseases Research	000	1	3/25/2026	NEW	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2023	TISSUE TESTING TECHNOLOGIES LLC	2231 TECHNICAL PKWY	CHARLESTON	SC	29406	CHARLESTON	USA	Cardiovascular Diseases Research	000	1	10/22/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $610,972 )
2023	2023	TISSUE TESTING TECHNOLOGIES LLC	2231 TECHNICAL PKWY	CHARLESTON	SC	29406	CHARLESTON	USA	Cardiovascular Diseases Research	003	1	6/21/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2023	TISSUE TESTING TECHNOLOGIES LLC	2231 TECHNICAL PKWY	CHARLESTON	SC	29406	CHARLESTON	USA	Cardiovascular Diseases Research	001	1	5/8/2023	NEW	$0
2023	2023	TISSUE TESTING TECHNOLOGIES LLC	2231 TECHNICAL PKWY	CHARLESTON	SC	29406	CHARLESTON	USA	Cardiovascular Diseases Research	000	1	3/29/2023	NEW	$452,184
2023	2023	TISSUE TESTING TECHNOLOGIES LLC	2231 TECHNICAL PKWY	CHARLESTON	SC	29406	CHARLESTON	USA	Cardiovascular Diseases Research	002	1	5/15/2023	SUPPLEMENT FOR EXPANSION	$158,788
														Subtotal = $610,972

Grand Total All Awards = $610,972

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Evaluation of growth potential of ice-free vitrified heart valves in a pediatric porcine model.

Award Number: R41HL169059

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2023

PERIOD OF PERFORMANCE END DATE: 09/30/2025

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