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Chitosan Guided Bone Regeneration Membranes for Dual Local Delivery of Simvastatin and Raspberry Ketone

Award Number: R01DE026759
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Chitosan Guided Bone Regeneration Membranes for Dual Local Delivery of Simvastatin and Raspberry Ketone - We propose newly developed electrospun chitosan guided bone regeneration (GBR) membranes for local delivery of simvastatin (SMV), an alternative to BMP-2, and raspberry ketone (RK), an anti- inflammatory/pro-healing agent, as a novel adjunctive therapy to heal grafted dental/craniomaxillofacial defects. GBR membranes are widely used in dental/craniomaxillofacial applications to protect bone grafted spaces from invasion by soft tissues and by providing an osteogenic environment for enhancing bone regeneration. Our chitosan GBR membranes overcome limitations of current GBR membranes by providing predictable degradation, and biomimetic nanofiber structure with an interconnected porosity that that is cell occlusive but allows exchange of fluids and signals between healing bone and epithelial compartments. The nanofiber structure also provides high surface area that is advantageous for drug loading and delivery. Our goal is to synergize our chitosan GBR membranes with local delivery of RK and SMV, to create novel bioactive GBR membranes that promote healing by stimulating the transition of the macrophage phenotype from pro-inflammation to pro-healing and promoting osteogenesis that significantly augments healing of grafted dental/craniomaxillofacial defects, especially large traumatic defects. Innovation of this work arises from our unique strategies that stabilize nanofiber structure of the electrospun chitosan and in the local delivery of SMV, an economical alternative to BMP-2 for stimulating bone formation, and the novel RK compound, to provide anti- inflammatory/pro-healing characteristics. Delivery of these agents from our GBR membranes will result in adjunctive implants that afford surgeons flexibility in choice of graft materials to be used with the GBR membrane in accordance with graft availability, clinician and patient factors, and may serve as a platform for overcoming inflammation and stimulating healing in other tissue engineering applications. In this work we will first, investigate individual delivery of RK (aim 1) and SMV (aim 2) from membranes, and effects on macrophage phenotype and osteogenesis in vitro and in rat calvarial models. We will then (aim 3) investigate dual release for synergistic/antagonistic effects on cells and healing of grafted site as compared to commercial GBR membrane in rat models. Finally (aim 4) the dual loaded bioactive chitosan GBR membranes will be investigated in a pre-clinical porcine model as compared to commercial devices. This work will have a large impact in augmenting dental/craniomaxillofacial bone regeneration especially in challenging traumatic bone injuries and lead to improved restoration of facial esthetics and subsequent dental/craniofacial implant therapies. These membranes may also find application in augmenting treatments in challenging large segmental orthopedic defects


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: 2025 ( Subtotal = -$125,211 )
2025	2021	UNIVERSITY OF MEMPHIS	115 JOHN WILDER TOWER	MEMPHIS	TN	38152	SHELBY	USA	Oral Diseases and Disorders Research	000	5	4/1/2025	NON-COMPETING CONTINUATION	-$125,211
														Subtotal = -$125,211

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2021	UNIVERSITY OF MEMPHIS	115 JOHN WILDER TOWER	MEMPHIS	TN	38152	SHELBY	USA	Oral Diseases and Disorders Research	000	5	3/28/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	UNIVERSITY OF MEMPHIS, THE	101 WILDER TOWER	MEMPHIS	TN	38152	SHELBY	USA	Oral Diseases and Disorders Research	000	5	3/13/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $437,292 )
2021	2021	UNIVERSITY OF MEMPHIS, THE	101 WILDER TOWER	MEMPHIS	TN	38152	SHELBY	USA	Oral Diseases and Disorders Research	000	5	3/17/2021	NON-COMPETING CONTINUATION	$437,292
														Subtotal = $437,292

Issue Date FY: 2020 ( Subtotal = $439,015 )
2020	2020	UNIVERSITY OF MEMPHIS, THE	101 WILDER TOWER	MEMPHIS	TN	38152	SHELBY	USA	Oral Diseases and Disorders Research	000	4	3/11/2020	NON-COMPETING CONTINUATION	$439,015
														Subtotal = $439,015

Issue Date FY: 2019 ( Subtotal = $356,754 )
2019	2019	UNIVERSITY OF MEMPHIS, THE	101 WILDER TOWER	MEMPHIS	TN	38152	SHELBY	USA	Oral Diseases and Disorders Research	000	3	3/12/2019	NON-COMPETING CONTINUATION	$356,754
														Subtotal = $356,754

Issue Date FY: 2018 ( Subtotal = $321,144 )
2018	2018	UNIVERSITY OF MEMPHIS, THE	101 WILDER TOWER	MEMPHIS	TN	38152	SHELBY	USA	Oral Diseases and Disorders Research	001	2	4/26/2018	NON-COMPETING CONTINUATION	$32,115
2018	2018	UNIVERSITY OF MEMPHIS, THE	101 WILDER TOWER	MEMPHIS	TN	38152	SHELBY	USA	Oral Diseases and Disorders Research	000	2	3/1/2018	NON-COMPETING CONTINUATION	$289,029
														Subtotal = $321,144

Issue Date FY: 2017 ( Subtotal = $330,892 )
2017	2017	UNIVERSITY OF MEMPHIS, THE	315 ADMINISTRATION BLDG	MEMPHIS	TN	38152	SHELBY	USA	Oral Diseases and Disorders Research	000	1	3/7/2017	NEW	$330,892
														Subtotal = $330,892

Grand Total All Awards = $1,759,886

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Chitosan Guided Bone Regeneration Membranes for Dual Local Delivery of Simvastatin and Raspberry Ketone

Award Number: R01DE026759

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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