Collagen-based tissue guidance biofabric for treatment of stress urinary incontinence

基于胶原蛋白的组织引导生物纤维用于治疗压力性尿失禁

• 批准号: 10010584
• 负责人: Subba Shankar
• 金额: $ 76.88万
• 依托单位: COLLAMEDIX INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-15 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10010584
• 关键词: Abdomen; Absorbable Implants; Allografting; Automation; Biocompatible Materials; Caliber; Cattle; Cells; Chronic; Cicatrix; Clinical; Collagen; Collagen Type I; Complex; Connective Tissue; Data; Data Collection; Deposition; Development; Device Designs; Devices; Diamond; Disease; Ensure; Equilibrium; Failure; Family; Fascia; Feedback; Female; Filament; Freezing; Funding; Growth; Hernia; Histologic; Histology; Human; Implant; Incidence; Inflammation; Legal patent; Life; Ligaments; Measures; Mechanics; Medical; Medical Device; Modulus; Operative Surgical Procedures; Organism; Orthopedics; Oryctolagus cuniculus; Pattern; Pelvic Floor Disorders; Pelvis; Phase; Plants; Polypropylenes; Porosity; Process; Production; Property; Rattus; Reporting; Running; Shapes; Sheep; Shipping; Sterility; Sterilization; Stress Urinary Incontinence; Structure; System; Techniques; Tendon structure; Testing; Time; Tissues; Toxic effect; Universities; Validation; Weight-Bearing state; Woman; Work; Xenograft procedure; aged; base; biomaterial compatibility; clinical application; cost; density; design; health application; implant design; implantation; improved; in vivo; innovation; meetings; novel; pelvic organ prolapse; physical property; prototype; reconstitution; repaired; response; scale up; side effect; soft tissue; standard of care; subcutaneous; tissue repair; verification and validation; wound

Innovation in approaches for soft tissue repair and support involving connective tissue laxity are needed for many clinical applications. These include developing improved treatments for female pelvic floor disorders, ab- dominal surgical repair (hernia), orthopedic applications for tendon and ligament repairs. Some of these disorders, such as stress urinary incontinence (SUI) in women, pelvic organ prolapse (POP) and hernia repair, are treated by using synthetics such as polypropylene mesh as the standard of care. Nonetheless there is a high reported incidence of complications relating to the implantation of polypropylene mesh in pelvic floor disorders. Other biomaterials, such as decellularized allografts or xenografts, lack porosity to accommodate tissue integration; thus, their physical properties diminish over time, resulting in functional failure. There is, therefore, a strong clinical need to develop innovative soft-tissue repair and support products to treat these life-altering conditions in women and such products would also impact hernia, orthopedic repairs, and other fields as well. CollaMedix is developing new implantable medical devices based on pure collagen threads formed by a novel, patented electrochemical compaction process. Medical-grade solubilized bovine Type I collagen is electrocompacted into threads that are among the most dense and strongest forms of reconstituted collagen. Therefore, these threads can be woven or filament-wound into complex shapes to make a biofabric (CollaFabric™) to form a wide variety of bioabsorbable implants that have ample porosity for tissue ingrowth and rapid integration. CollaFabric produces a new tissue growth response in the body while it is being broken down; thus, it performs better than synthetic plastic implants, while avoiding negative side effects, including extrusion, erosion, and chronic inflammation. CollaMedix and co-inventors at Case Western Reserve University have conducted extensive preliminary biocompatibility studies on CollaFabric in rats, rabbits, and recently on sheep, that showed excellent tissue integration and strength even at 6 months. The first family of products produced from CollaFabric will be for the treatment of SUI and POP in women, followed by products for other applications. The aim of this project is to complete the development of a SUI treatment for women based on CollaFabric. The proposed activities and data collection are based on direct feedback from FDA. The design of existing CollaFabric prototypes will be optimized and the design frozen. The design will then be verified and validated, including packaging validation, sterilization validation, biocompatibility testing, and in vivo implant testing, with comparison to an existing predicate, in a 6-month sheep study. The end result of this work will be an FDA 510(k) application.

需要创新软组织修复方法和涉及结缔组织松弛的支持 许多临床应用，包括开发针对女性盆底疾病的改进疗法。 腹部手术修复（疝气）、肌腱和韧带修复的骨科应用。 疾病，例如女​​性压力性尿失禁（SUI）、盆腔器官脱垂（POP）和疝气修复， 虽然使用聚丙烯网等合成材料进行处理，但护理标准很高。 报告了与盆底疾病植入聚丙烯网相关的并发症发生率。 其他生物材料，例如脱细胞同种异体移植物或异种移植物，缺乏容纳组织的孔隙度 整合；因此，它们的物理特性随着时间的推移而减弱，从而导致功能失效。 临床强烈需要开发创新的软组织修复和支持产品来治疗这些改变生活的疾病 妇女的状况和此类产品也会影响疝气、骨科修复和其他领域。 CollaMedix 正在开发基于纯胶原线的新型植入式医疗设备，该线由一种新颖的、 获得专利的电化学压实工艺是医用级溶解牛 I 型胶原蛋白。 电压成线，是最致密和最强的重组胶原蛋白形式之一。 因此，这些线可以编织或缠绕成复杂的形状以制造生物纤维 (CollaFabric™) 形成各种可生物吸收的植入物，这些植入物具有充足的孔隙率，适合组织向内生长和 CollaFabric 在分解的同时在体内产生新的组织生长反应； 因此，它的性能比合成塑料植入物更好，同时避免了负面副作用，包括挤压、 CollaMedix 和凯斯西储大学的共同发明者已经发现了侵蚀和慢性炎症。 对 CollaFabric 在大鼠、兔子以及最近的绵羊身上进行了广泛的初步生物相容性研究， 即使在 6 个月时，也显示出出色的组织整合性和强度。 CollaFabric 的产品将用于治疗女性 SUI 和 POP，随后将推出用于其他应用的产品。 该项目的目的是完成基于 CollaFabric 的女性 SUI 治疗方法的开发。 拟议的活动和数据收集基于 FDA 的直接反馈。 CollaFabric 原型将被优化，设计将被冻结，然后设计将被验证和验证。 包括包装验证、灭菌验证、生物相容性测试和体内植入测试， 在为期 6 个月的绵羊研究中与现有谓词进行比较 这项工作的最终结果将是 FDA 510(k)。 应用。