Sprayable Hydrogel Barrier for the Delivery of Adhesion-Preventing Therapeutics

用于提供防粘连治疗的可喷雾水凝胶屏障

• 批准号: 10696561
• 负责人: Lauren Costella
• 金额: $ 27.07万
• 依托单位: LUNA LABS USA, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-20 至 2024-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10696561
• 关键词: Abdomen; Abdominal Cavity; Address; Adhesions; Alginates; American; Animal Model; Anti-Inflammatory Agents; Antihypertensive Agents; Biological; Biomedical Research; Cellular Assay; Chemistry; Chitosan; Clinical; Crosslinker; Development; Dexamethasone; Encapsulated; FDA approved; Female; Female infertility; Fibrin; Fibrinolysis; Fibrosis; Film; Formulation; Goals; Government; Health; Healthcare Systems; Hydrogels; In Vitro; Incidence; Infertility; Inflammation; Inflammatory; Injury to Peritoneum; Interruption; Intestinal Obstruction; Intra-abdominal; Kinetics; Life; Liquid substance; Losartan; Marketing; Methods; Modeling; Mus; National Institute of General Medical Sciences; Operative Surgical Procedures; Oryctolagus cuniculus; Outcome; Peritoneum; Pharmaceutical Preparations; Phase; Polymers; Postoperative Complications; Postoperative Period; Prevention; Procedures; Rattus; Research; Risk; Rodent; Safety; Science; Severities; Site; Small Business Innovation Research Grant; Small Intestines; Solid; Surface; Surgical incisions; Therapeutic; Therapeutic Agents; Therapeutic Uses; Tissues; Unnecessary Procedures; Water; aqueous; atorvastatin; commercialization; cost; crosslink; cytokine; dosage; efficacy validation; fertility preservation; first-in-human; healing; improved; in vivo; in vivo evaluation; injured; interest; meetings; migration; novel; prevent; programs; reproductive tract; response; technology validation; wound healing

ABSTRACT Adhesion formation after intra-abdominal surgery poses a significant health risk, cited as a leading cause of small bowel obstruction and female infertility. Methods to prevent these adhesions are currently limited to barrier films, which are difficult to place and are often restricted to use preventing adhesions to the surgical incision site, leaving the bulk of the abdominal contents unprotected. These barrier products also fail to address the tissue response that causes most adhesions. This program will focus on the optimization of a low-cost, sprayable barrier that will flow around and adhere to the internal tissues of the abdominal cavity, providing protection from adhesions for all internal surfaces. This hydrogel will also deliver anti-inflammatory or fibrinolytic therapeutics to mitigate local biological responses responsible for adhesion formation. Luna Labs will optimize the product formulation using in vitro characterization before completing preliminary validation of efficacy in a rodent abdominal model of adhesion formation. These results will support a Phase II transition effort towards product commercialization and submission to the FDA.

摘要 腹部手术后粘连的形成对健康构成重大风险，被认为是导致小 肠梗阻和女性不孕症。防止这些粘连的方法目前仅限于屏障 很难放置的薄膜，通常被限制用于防止粘连到手术切口处， 腹部的大部分内容物没有受到保护。这些屏障产品也不能解决组织问题 导致大多数粘连的反应。该计划将重点关注低成本、可喷雾屏障的优化 它会流过并附着在腹膜腔的内部组织上，从而保护身体免受 所有内表面的粘合剂。这种水凝胶还可以提供抗炎或纤溶治疗药物。 以减轻导致粘连形成的局部生物反应。露娜实验室将对产品进行优化 在完成对啮齿动物的疗效初步验证之前使用体外表征的配方 腹部粘连形成模型。这些结果将支持向产品的第二阶段过渡工作 商业化并提交给FDA。