Antimicrobial dermal matrices to promote infection free wound closure in cutaneous wounds

抗菌真皮基质促进皮肤伤口无感染伤口闭合

• 批准号: 10001816
• 负责人: Manav Mehta
• 金额: $ 169.99万
• 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 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10001816
• 关键词: American; Amputation; Anti-Bacterial Agents; Antibiotic Resistance; Antibiotics; Area; Bacteria; Bacterial Antibiotic Resistance; Biocompatible Materials; Biological; Biomedical Technology; Biophysics; Caring; Cell-Matrix Junction; Cells; Cellular Infiltration; Centers for Disease Control and Prevention (U.S.); Cessation of life; Charge; Clinic; Clinical; Data; Dermal; Development; Drug resistance; Effectiveness; Environment; Exhibits; Family suidae; Formulation; Gel; Goals; Gram-Negative Bacteria; Guidelines; Health; Hospitals; Hydrogels; In Vitro; Infection; Infection prevention; Inpatients; Local Anti-Infective Agents; Mammalian Cell; Membrane; Methods; Modality; Multi-Drug Resistance; Names; Natural regeneration; Outcome; Outpatients; Pathogenicity; Patients; Peptides; Phase; Process; Property; Quality Control; Repeat Surgery; Reporting; Resistance development; Safety; Shapes; Site; Skin; Skin Substitutes; Small Business Innovation Research Grant; Speed; Staphylococcal Infections; Staphylococcus aureus; Sterility; Structure; Testing; Thinness; TimeLine; Tissues; Toxic effect; Wound Infection; antimicrobial; bacterial resistance; base; biomaterial compatibility; chronic wound; cost; design; drug resistant bacteria; drug resistant pathogen; efficacy study; fighting; healing; improved; in vivo; innovation; methicillin resistant Staphylococcus aureus; multi-drug resistant pathogen; novel; pathogen; pre-clinical; preclinical safety; prevent; research clinical testing; resistant strain; safety study; scaffold; self assembly; skin wound; small molecule; technological innovation; tissue regeneration; tissue repair; tissue support frame; wound; wound care; wound closure; wound dressing; 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：这个快速轨道项目旨在测试自组装肽水凝胶的可行性 伤口的治疗。伤口护理目前是一个昂贵的多步骤过程，其中伤口接受治疗 使用顺序产物到1）用抗生素去除病原体，2）促进健康的细胞环境 通过水凝胶施加，3）用皮肤替代品关闭伤口。因此，提出的产品 G4DERM能够通过生物物理破坏来同时消除耐药性病原体 细菌膜，同时促进宿主组织再生而没有添加抗生素或生物制剂。 该产品可用于住院和门诊伤口护理诊所，以治愈感染药物的患者 耐药细菌，并减少由于慢性而在美国每年进行的100,000个截肢 伤口。 关键词：组织再生，感染，伤口愈合，生物材料，抗菌素 应用领域：组织再生和修复，伤口愈合，感染 亚主题名称：生物医学（BM）技术 知识分子的优点：这个快速提案将产生510（k），启用数据证明安全性和 G4Derm作为抗菌细胞c型基质的功效，与抗生素同时有毒 耐药性细菌菌株，同时还有利于组织再生。当前产品使用 接触后，基于电荷的基于裂解细菌膜的机制，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：这项快速提案的更广泛影响将是一部小说的发展 抗菌机制也可以消除受感染伤口的抗药性细菌菌株。 根据疾病控制与预防中心的报告，抗生素耐药细菌会引起 每年有200万美国人的严重感染，每年估计死亡23,000人。我们的 与抗生素抗性细菌作斗争的能力正在减少，而新的潜在抗生素药物的管道 正在增长。自1998年以来，只有9种新的抗生素获得了FDA的批准，其中只有2种 结合了新型作用机理。因此，拟议的产品提供了前所未有的 同时消除细菌的结合，同时促进tisue再生。作为抗菌 机制是生物物理，细菌不太可能对该产品产生抗性。