Flowable antimicrobial skin scaffolding matrix that promotes regeneration

促进再生的可流动抗菌皮肤支架基质

基本信息

批准号：
9048528
负责人：
Manav Mehta
金额：
$ 22.34万
依托单位：
GEL4MED, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-05-15 至 2018-02-14
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9048528
关键词：
Aftercare Amino Acids Amputation Animals Anti-Bacterial Agents Antibiotic Resistance Antibiotics Antimicrobial Effect Arginine Bacteria Binding Caring Cell membrane Cell-Matrix Junction Cells Cellular Infiltration Cessation of life Characteristics Charge Clinical Services Code Cytolysis Delaware Deposition Dorsal Extracellular Matrix Family suidae Formulation Gel Goals Healed Health Professional Histopathology Hospitalization Hospitals Human Hydrogels In Vitro Infection Infection prevention Lead Legal patent Letters Licensing Local Anti-Infective Agents Measurement Measures Membrane Methods Modality Modeling Monitor Multi-Drug Resistance Natural regeneration Operative Surgical Procedures Optics Patients Peptides Phase Preparation Property Provider Repeat Surgery Reporting Rodent Model Shapes Site Skin Skin Substitutes Small Business Innovation Research Grant Staphylococcus aureus Surface Technology Testing Therapeutic Thick Time Tissues Topical application Toxic effect Universities Work Wound Healing Wound Infection antimicrobial base cost design disease transmission healing in vivo killings mouse model multi-drug resistant pathogen nanofiber pathogen pre-clinical prevent public health relevance scaffold tissue regeneration tissue support frame wound

项目摘要

DESCRIPTION (provided by applicant): The goal of this Phase I SBIR proposal is to test the feasibility of an antimicrobial tissue scaffolding hydrogel matrix in eliminating infecting bacteril pathogens and promoting wound regeneration. Preventing and treating wound infections and regeneration are becoming less effective due to the rapid rise in Multi-drug Resistant Organisms (MDRO). A recent study by Pada et al. (2011) reported that patients with MRSA-infected wounds were 10.2 times more likely to die during their hospitalization, had 4.6 times longer hospitalization, and incurred 4 times higher hospitalization costs when compared to patients without infection. Patients who do survive MRSA (multidrug-resistant Staphylococcus aureus) often spend months in the hospital and endure repeated surgeries to cut out infected tissue. In 1974, 2% of staph infections were MRSA. By 1995, the number had climbed to 22%, and now is over 60% and still rising. The proposed product will treat wounds by both (i) preventing infection through a unique mechanism of action that is broad spectrum antibacterial, and (2) it will promote tissue regeneration by providing cell attachment sites within the scaffolding matrix. Additionally, the gel formulation of the proposed product allows it to be flowable and conform to unique wound shapes and depths easily, so it can be administered quickly by any healthcare professional. To establish the feasibility, we propose the following two specific aims: Specific aim 1) Demonstrate the therapeutic in vivo efficacy of the product to eliminate infection from a wound in a mouse model infected with Staphylococcus aureus (S. aureus). Milestones: Show elimination of S. aureus from wounds to 99.9% or below as quantified by bacterial titers Specific aim 2) Demonstrate the in vivo efficacy of the hydrogel to promote healing of full-thickness dorsal excisional wounds in swine. Milestones: Show accelerated wound healing by day 14. In SBIR Phase II, we will validate the hydrogel in an infected wound healing swine model, establish GMP manufacturing, and execute GLP studies in preparation for our FDA submission.

描述（由申请人提供）：第一阶段 SBIR 提案的目标是测试抗菌组织支架水凝胶基质在消除感染细菌病原体和促进伤口再生方面的可行性。 Pada 等人 (2011) 最近的一项研究报告称，MRSA 感染患者的数量迅速增加。与未感染 MRSA（多重耐药金黄色葡萄球菌）的患者相比，有伤口的患者在住院期间死亡的可能性高出 10.2 倍，住院时间长出 4.6 倍，住院费用高出 4 倍。 1974 年，2% 的葡萄球菌感染是 MRSA，这一数字已增至 22%。超过 60% 并且仍在上升，该产品将通过以下两种方式治疗伤口：(i) 通过独特的广谱抗菌作用机制预防感染，(2) 通过在支架基质内提供细胞附着位点来促进组织再生。此外，所提议产品的凝胶配方使其具有流动性，并且易于适应独特的伤口形状和深度，因此任何医疗保健专业人员都可以快速施用。为了确定可行性，我们提出以下两个具体目标：具体目标。 1) 展示治疗效果该产品在感染金黄色葡萄球菌（S. aureus）的小鼠模型中消除伤口感染的体内功效里程碑：通过细菌滴度定量显示，伤口中金黄色葡萄球菌的消除率达到 99.9% 或更低具体目标 2)。展示水凝胶促进猪背部全层切除伤口愈合的体内功效里程碑：显示第 14 天伤口愈合加速。 SBIR 第二阶段，我们将在受感染的伤口愈合猪模型中验证水凝胶，建立 GMP 生产，并执行 GLP 研究，为 FDA 提交做准备。