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