TABA funding for the Fast Track project "ANTIMICROBIAL DERMAL MATRICES TO PROMOTE INFECTION FREE WOUND CLOSURE IN CUTANEOUS WOUNDS_R44GM133305"

TABA 资助快速通道项目“抗菌真皮基质促进皮肤伤口无感染伤口闭合_R44GM133305”

• 批准号: 10526336
• 负责人: Manav Mehta
• 金额: $ 5万
• 依托单位: GEL4MED, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2023-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10526336
• 关键词: American; Amputation; Anti-Bacterial Agents; Antibiotic Resistance; Antibiotics; Area; Bacteria; Bacterial Antibiotic Resistance; Biocompatible Materials; Biological Products; Biomedical Technology; Biophysics; Cell-Matrix Junction; Cells; Cellular Infiltration; Centers for Disease Control and Prevention (U.S.); Cessation of life; Charge; Clinic; Data; Dermal; Development; Drug resistance; Environment; Funding; Hydrogels; Infection; Inpatients; Membrane; Names; Natural regeneration; Outpatients; Patients; Peptides; Process; Property; Reporting; Resistance development; Safety; Shapes; Skin; Skin Substitutes; Structure; Thinness; Wound Infection; antimicrobial; bacterial resistance; base; chronic wound; design; drug resistant bacteria; drug resistant pathogen; feasibility testing; fighting; healing; novel; pathogen; scaffold; self assembly; skin wound; tissue regeneration; tissue repair; tissue support frame; wound; wound care; wound closure; wound healing; wound treatment

Overview: This Fast track project aims to test the feasibility of a self-assembly peptide hydrogel for the treatment of wounds. Wound care is currently an expensive, multistep process in which wounds are treated with sequential products to 1) remove pathogens with antibiotics, 2) promote a healthy cellular environment through hydrogel application, and 3) close the wound with skin substitutes. Thus, the proposed product G4Derm is capable of simultaneously removing drug resistant pathogens through biophysical disruption of bacterial membranes, while promoting host tissue regeneration without added antibiotics or biologics. This product can be used in inpatient and outpatient wound care clinics to heal patients infected with drug resistant bacteria, and to reduce the 100,000 amputations performed each year in the US due to chronic wounds. Key words: tissue regeneration, infections, wound healing, biomaterials, antimicrobial Areas of application: tissue regeneration and repair, wound healing, infections Subtopic name: Biomedical (BM) Technologies Intellectual Merit: This Fast track proposal will generate 510(k) enabling data demonstrating safety and efficacy of G4Derm as an antimicrobial cell-scaffolding matrix that is simultaneously toxic to antibiotic- resistant bacterial strains, while remaining conducive to tissue regeneration. The current product uses a charge-based mechanism to lyse bacterial membranes upon contact and has a porous structure to promote cellular infiltration and cell attachment. Broader Impact: The broader impact of this Fast track proposal would be the development of a novel antimicrobial mechanism that can eliminate even drug-resistant bacterial strains from infected wounds. According to the Centers for Disease Control and Prevention Report, antibiotic-resistant bacteria will cause serious infections in 2 million Americans each year, resulting in an estimated 23,000 deaths annually. Our ability to fight antibiotic-resistant bacteria is diminishing, and the pipeline of new potential antibiotic drugs is growing lean. Only 9 new antibiotics have received FDA approval since 1998, of which only 2 of these incorporated novel mechanisms of action. Hence, the proposed product offers the unprecedented combination of simultaneous bacterial elimination while promoting tisue regeneration. As the antibacterial mechanism is biophysical, bacteria are unlikely to develop resistance to this product.

概述：该快速通道项目旨在测试自组装肽水凝胶用于 治疗伤口。目前，伤口护理是一个昂贵的、多步骤的伤口治疗过程 使用连续产品 1) 使用抗生素去除病原体，2) 促进健康的细胞环境 通过水凝胶应用，3）用皮肤替代品闭合伤口。因此，建议的产品 G4Derm 能够通过生物物理破坏同时消除耐药病原体 细菌膜，同时促进宿主组织再生，无需添加抗生素或生物制剂。 本产品可用于住院和门诊伤口护理诊所，治疗药物感染患者 抗药性细菌，并减少美国每年因慢性病而进行的 100,000 例截肢手术 伤口。 关键词: 组织再生, 感染, 伤口愈合, 生物材料, 抗菌 应用领域：组织再生和修复、伤口愈合、感染 子主题名称：生物医学（BM）技术 智力优点：该快速通道提案将生成 510(k) 支持数据，证明安全性和 G4Derm 作为抗菌细胞支架基质的功效，同时对抗生素具有毒性 耐药菌株，同时保持有利于组织再生。目前的产品采用的是 基于电荷的机制在接触时裂解细菌膜，并具有多孔结构以促进 细胞浸润和细胞附着。 更广泛的影响：该快速通道提案的更广泛影响将是开发一种新颖的 抗菌机制，甚至可以消除感染伤口中的耐药菌株。 根据疾病控制和预防中心的报告，抗生素耐药性细菌会导致 每年有 200 万美国人遭受严重感染，估计每年导致 23,000 人死亡。我们的 对抗抗生素耐药细菌的能力正在减弱，新的潜在抗生素药物正在研发中 正在变瘦。自1998年以来，只有9种新抗生素获得FDA批准，其中只有2种 纳入新颖的作用机制。因此，所提出的产品提供了前所未有的 同时消除细菌，同时促进组织再生。作为抗菌 机制是生物物理的，细菌不太可能对该产品产生耐药性。