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: 10611752
• 负责人: Manav Mehta
• 金额: $ 120万
• 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 2024-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10611752
• 关键词: Acceleration; Adoption; Affect; American; Amputation; Animals; Anti-Bacterial Agents; Antibiotic Resistance; Antibiotic susceptibility; Antibiotics; Antifungal Agents; Area; Award; Bacteria; Bacterial Antibiotic Resistance; Biocompatible Materials; Biological; Biological Products; Biomedical Technology; Biophysics; Budgets; Businesses; Cell-Matrix Junction; Cells; Cellular Infiltration; Centers for Disease Control and Prevention (U.S.); Cessation of life; Characteristics; Charge; Clinic; Clinical; Clinical Trials; Consumption; Counseling; Data; Debridement; Delaware; Dermal; Devices; Diabetic Foot Ulcer; Discipline of Nursing; Drug resistance; Economics; Effectiveness; Elements; Environment; Evaluation; Failure; Family suidae; Formulation; Frequencies; Funding; Gel; Growth; Guidelines; Health; Health Care Costs; Healthcare; Healthcare Systems; Hydrogels; In Vitro; Infection; Inpatients; Intellectual Property; Legal patent; Length of Stay; Letters; Licensing; Life; Mammalian Cell; Managed Care; Marketing; Medical Device; Membrane; Microbial Biofilms; Microbiology; Mus; Names; Natural regeneration; Operative Surgical Procedures; Outcome; Outpatients; Pain; Pathogenicity; Pathway interactions; Patients; Peptides; Periodicity; Pilot Projects; Polymers; Porosity; Preparation; Price; Privatization; Process; Production; Property; Pseudomonas aeruginosa; Reporting; Research; Research Personnel; Resistance development; Safety; Sales; Shapes; Skin; Skin Substitutes; Small Business Innovation Research Grant; Sterile coverings; Sterilization; Structure; Technology; Temperature; Testing; Thinness; Time; Treatment Cost; Ulcer; Water; Work; Wound Infection; Wound models; antimicrobial; antimicrobial dressing; bacterial resistance; care burden; chronic wound; clinical trial protocol; clinical trial readiness; commercialization; commercialization readiness; cost; design; drug resistant bacteria; drug resistant microorganism; fabrication; fighting; healing; in vivo; manufacture; methicillin resistant Staphylococcus aureus; microbial; multi-drug resistant pathogen; new technology; non-healing wounds; novel; pathogen; porcine model; prevent; recurrent infection; scaffold; self assembly; skin wound; soft tissue; standard of care; tissue regeneration; tissue repair; wound; wound bed; wound care; wound closure; wound environment; wound healing; wound treatment

Overview: This CRP project aims at enabling regulatory clearance/approval and accelerating commercial availability of a self-assembly peptide-based matrix (G4Derm) for the management of wounds. Wound care is currently an expensive, multistep, and often cyclic 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. The proposed product, G4Derm, is capable of simultaneously removing drug- resistant microbes through biophysical disruption of bacterial membranes, while promoting host tissue regeneration without added antibiotics or biologics. G4Derm 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 CRP proposal will allow for completion of the FDA 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 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: This CRP funding would enable the regulatory clearance and product launch of G4Derm, providing healthcare systems with a novel antimicrobial technology that can eliminate even drug-resistant bacterial strains from infected wounds while simultaneously promoting wound closure via tissue regeneration. 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 pathogen elimination and host tissue regeneration. As the antibacterial mechanism is biophysical, bacteria are unlikely to develop resistance to this product.

概述：该CRP项目旨在实现监管许可/批准，并加快 用于管理的基于自组装肽的基质（G4 Derm）的商业可用性 伤口。伤口护理目前是昂贵的、多步骤的并且通常是循环的过程，其中， 用连续产品治疗伤口，以1）用抗生素去除病原体，2）促进 通过水凝胶应用获得健康的细胞环境，以及3）用皮肤闭合伤口 替代品申报产品G4 Derm能够同时清除药物- 通过生物物理破坏细菌膜，同时促进宿主 组织再生而不添加抗生素或生物制剂。G4 Derm可用于住院患者 和门诊伤口护理诊所，以治愈感染耐药细菌的患者， 减少美国每年因慢性伤口而进行的10万例截肢手术。 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 知识价值：本CRP提案将允许完成FDA 510（k）启用数据 证明了G4 Derm作为抗微生物细胞支架基质的安全性和有效性， 同时对耐药性细菌菌株有毒，同时保持有益于组织 再生该产品使用基于电荷的机制裂解细菌膜， 接触，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CRP资金将使监管许可和产品推出， G4 Derm，为医疗保健系统提供一种新型的抗菌技术， 即使是来自感染伤口的耐药菌株， 通过组织再生进行闭合。根据疾病控制和预防中心的数据， 报告称，耐药细菌每年将导致200万美国人严重感染， 每年造成约23,000人死亡。我们对抗抗药性细菌的能力 正在减少，新的潜在抗生素药物的管道越来越少。9新 自1998年以来，FDA已经批准了抗生素，其中只有2种抗生素包含了新的抗生素。 行动机制。因此，拟议的产品提供了前所未有的组合， 同时消除病原体和宿主组织再生。作为抗菌机制 是生物物理的，细菌不太可能对本产品产生耐药性。