Translating a biostimulatory implant for the long-term treatment of glottic insufficiency
将生物刺激植入物用于声门功能不全的长期治疗
基本信息
- 批准号:10650269
- 负责人:
- 金额:$ 60.06万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-08-01 至 2028-07-31
- 项目状态:未结题
- 来源:
- 关键词:AccidentsAcuteAddressAdverse eventBiocompatible MaterialsBiologicalBiological AssayBiomechanicsCadaverCellsCharacteristicsClinicalClinical ResearchClinical TrialsCommunication impairmentComplexCytometryDeglutitionEvaluationExtracellular MatrixFingerprintFunctional disorderGelGoalsGood Manufacturing ProcessHomeostasisHumanHydrogelsHypersensitivityImmobilizationImplantIn SituInflammationInjectableInjectionsIntramuscularLaryngeal DiseasesLarynxMechanicsMethodsModelingModulusMolecularNanoporousOperative Surgical ProceduresParalysedPhasePilot ProjectsPliabilityPorosityPositioning AttributePre-Clinical ModelPropertyRadiationRaman Spectrum AnalysisRetrievalSafetySecureTestingTimeTissuesTitrationsToxic effectToxicologyTranslatingTraumaVoicecommon treatmentcytotoxicitydesignergonomicsfirst-in-humangenotoxicityhigh dimensionalityhistiocyteimplantationimprovedin vivoindexingmechanical propertiesnanoindentationnovelparticlepre-clinicalresearch clinical testingresponsescaffoldstandard of caresuccesssystemic toxicitytechnology developmenttranslational potentialvocal cord
项目摘要
RFA-DC-22-001: Translating a biostimulatory implant for the long-term treatment of glottic
insufficiency
Abstract
Glottic insufficiency (GI) is a laryngeal disorder that can impair communication and swallowing
function due to vocal fold paralysis, presbylarynges, trauma, surgery, or radiation. The most common
treatment for GI is vocal fold augmentation with temporary nanoporous biomaterials that assist with
glottic closure. However, currently available materials poorly restore the biomechanical properties of
the native vocal fold and can be associated with dense histiocytic responses, while only lasting three
to eighteen months. In addition, vocal folds are a complex laminar tissue capable of producing voice
due to specific mechanical properties of the extracellular matrix and cellular components. However,
the structural, cellular, and intrinsic mechanical effects of vocal fold augmentation have not yet been
fully characterized, particularly after achieving homeostasis in situ. There is a need for a well
characterized and purposefully-designed injectable implant that can restore permanent laryngeal
function without producing inflammation or compromising vocal fold pliability. To address this need,
we developed a novel iteration of microporous annealed particle (MAP) scaffold that is
biomechanically matched to the vocal fold, capable of promoting tissue integration, and providing
persistent tissue bulk. This proposal aims to (1) develop assays of MAP-associated de novo
tissue formation, (2) characterize the clinical feasibility of in vivo delivery, (3) determine the
toxicology profile and (4) initiate a first-in-human clinical trial of MAP hydrogel vocal fold
augmentation.
RFA-DC-22-001:翻译生物刺激植入物用于声门炎的长期治疗
不足
摘要
声门功能不全(GI)是一种喉部疾病,可损害沟通和吞咽
由于声带麻痹、喉咙老化症、创伤、手术或放射而导致的功能障碍。最常见的
胃肠道感染的治疗是用临时的纳米多孔生物材料增强声带,以帮助
声门关闭。然而,目前可用的材料很难恢复生物力学性能
天然声带,可与密集的组织细胞反应有关,但仅持续三个月
到18个月。此外,声带是一种复杂的板层组织,能够发出声音
由于细胞外基质和细胞成分的特殊机械特性。然而,
声带扩大术的结构、细胞和内在机械效应尚未得到证实。
完全具有特征的,特别是在原位实现动态平衡之后。需要一口井
特制和有目的的可注射植入物,可恢复永久性喉部
功能不会产生炎症或影响声带的柔韧性。为了满足这一需求,
我们开发了一种新型的微孔退火颗粒(MAP)支架,即
生物力学与声带匹配,能够促进组织整合,并提供
持久的组织块。该建议旨在(1)开发与地图相关的从头测定法
组织形成,(2)表征体内给药的临床可行性,(3)确定
毒理学概况和(4)启动MAP水凝胶声带的首个人类临床试验
增强功能。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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James J. Daniero其他文献
Predicting Patient Needs for Interdisciplinary Services in a Voice and Swallowing Center.
预测语音和吞咽中心患者对跨学科服务的需求。
- DOI:
- 发表时间:
2020 - 期刊:
- 影响因子:2.2
- 作者:
Holly Hess;Nicholas A. Barone;James J. Daniero - 通讯作者:
James J. Daniero
Exploration of biomaterial-tissue integration in heterogeneous microporous annealed particle scaffolds in subcutaneous implants over 12 months
在皮下植入物中,超过 12 个月的异质微孔退火颗粒支架中生物材料与组织整合的探索
- DOI:
10.1016/j.actbio.2025.02.020 - 发表时间:
2025-04-01 - 期刊:
- 影响因子:9.600
- 作者:
Ethan Nicklow;Lauren J. Pruett;Neharika Singh;James J. Daniero;Donald R. Griffin - 通讯作者:
Donald R. Griffin
"Quality, Readability, and Understandability of Online Posterior Glottic Stenosis Information".
“在线声门后狭窄信息的质量、可读性和可理解性”。
- DOI:
10.1016/j.jvoice.2022.11.036 - 发表时间:
2022 - 期刊:
- 影响因子:0
- 作者:
Julian S. De La Chapa;Jeffrey R. Bellinger;Allyson R. Timm;James J. Daniero - 通讯作者:
James J. Daniero
Ultrasonic surgical aspirator‐assisted phonosurgery: A novel technique for laryngeal cartilage dissection
超声手术吸引器辅助声外科:喉软骨解剖的新技术
- DOI:
- 发表时间:
2014 - 期刊:
- 影响因子:0
- 作者:
James J. Daniero;J. Spiegel;R. Brody;M. Fickes - 通讯作者:
M. Fickes
Anatomy from the Inside Out
由内而外的解剖学
- DOI:
- 发表时间:
2020 - 期刊:
- 影响因子:0
- 作者:
Reed C Gilbow;James J. Daniero - 通讯作者:
James J. Daniero
James J. Daniero的其他文献
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{{ truncateString('James J. Daniero', 18)}}的其他基金
Novel Implementation of Microporous Annealed Particle HydroGel for Next-generation Posterior Pharyngeal Wall Augmentation
用于下一代咽后壁增强的微孔退火颗粒水凝胶的新实现
- 批准号:
10727361 - 财政年份:2023
- 资助金额:
$ 60.06万 - 项目类别:
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