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

基本信息

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
项目类别：
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

项目摘要

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.

抽象的腹腔内手术后的粘附形成构成显着的健康风险，被认为是小的主要原因肠梗阻和女性不育症。预防这些粘附的方法目前仅限于障碍薄膜很难放置，并且通常仅限于防止手术切口部位粘附的膜，使大部分腹部内容不受保护。这些障碍物也无法解决组织引起大多数粘附的反应。该程序将重点介绍低成本，可喷涂的障碍物的优化这将流过并粘附在腹腔的内部组织，从而保护所有内部表面的粘附。该水凝胶还将提供抗炎或纤维蛋白水解治疗剂减轻负责粘附形成的局部生物学反应。 Luna Labs将优化产品在完成啮齿动物的疗效初步验证之前，使用体外表征进行配方粘附形成的腹部模型。这些结果将支持对产品的第二阶段过渡工作商业化和提交FDA。