Prospective evaluation of a surgical solution for breast cancer-associated lymphedema

项目摘要/摘要 乳腺癌相关淋巴水肿外科治疗方案的前瞻性评价 拟议的项目将完成剩余的关键研究和技术要求，这些要求包括 需要商业化一种用于治疗继发性淋巴水肿的突破性介入设备 -一种慢性和衰弱的疾病，目前无法治愈，估计影响15%-30% 乳腺癌幸存者。 乳腺癌的分期和治愈通常需要手术，无论有没有辅助放射治疗。 心理治疗。这些干预措施虽然挽救了生命，但有时会破坏足够多的淋巴功能，以至于 乳腺癌幸存者的手臂状况可能包括疼痛的肿胀，经常 感染可能危及生命，并最终导致组织中不可逆转的结构性变化 导致严重畸形，严重降低功能和生活质量。 BioBridge是一种新型的线状胶原支架，旨在支持新健康的 淋巴管将修复乳腺癌相关患者的病变组织 淋巴浮肿。根据早期一项成功的大型动物研究的结果，可以假设这是 新型装置将提供有史以来第一种治疗方法，以显著恢复淋巴功能，减少 肿胀，提高患者的生活质量。 该项目的一个主要目标是评估BioBridge在人类受试者中的疗效。已定义的协议具有 已被开发出来，将用于测试120名与I期或II期乳腺癌相关的受试者 由斯坦福大学领导的一项多点临床研究中的淋巴水肿。当成功完成时， 这项研究将产生关键的量化数据，证实生物桥的能力 逆转疾病，并将其疗效与现有的淋巴水肿治疗策略进行比较。 另一个目标是扩大制造技术，以支持BioBridge的商业生产 设备。已经成功地开发和部署了专有制造工艺 适用于较低的批量生产。该项目现在将专注于开发和扩展下一代 沉积技术，以实现更大的商业容量。这个项目的最终目标是准备 并将临床结果提交监管部门批准和报销考虑使用 生物桥作为治疗淋巴水肿的介入性装置。 如果在完成这项研究时取得成功，将提供一个可行的、安全的和 对于这种严重影响乳腺癌存活率的常见疾病，需要采取必要的治疗方法。 它还将为更好地理解这种疾病以及再生的作用提供框架。 药物可以在未来治疗和预防淋巴水肿的策略中发挥作用。

Project Summary/Abstract Prospective evaluation of a surgical solution for breast cancer-associated lymphedema The proposed project will complete remaining key research and technology requirements that are needed to commercialize a ground-breaking interventional device for treating secondary lymphedema -- a chronic and debilitating disease that currently has no cure and impacts an estimated 15-30% of breast cancer survivors. Breast cancer staging and cure typically necessitates surgery, with or without adjunctive radiation therapy. These interventions, while life-saving, sometimes destroy enough lymphatic function that the breast cancer survivor is left with a condition in the arm that can include painful swelling, frequent infections that can be life-threatening and, ultimately, irreversible structural changes in the tissues that result in severe deformity, and serious reduction in function and quality-of-life. BioBridge is a novel, thread-like collagen scaffold designed to support the regeneration of new healthy lymphatic vessels that will repair diseased tissue in patients that are suffering from breast cancer related lymphedema. Based on results from an earlier, successful large animal study, it is hypothesize that this novel device will provide the first ever treatment to measurably restore lymphatic function, reduce swelling, and improve the patient’s quality of life. A primary goal of this project is evaluate BioBridge efficacy in human subjects. A defined protocol has been developed that will be used to test 120 subjects that have Stage I or Stage II breast cancer-related lymphedema in a multi-site clinical study and led by Stanford University. When successfully completed, the study will have generated critical quantitative data that will confirm the ability of the BioBridge to reverse disease and compare its efficacy to the existing treatment strategies for lymphedema. Another goal is to scale up the fabrication technology to support commercial production of BioBridge devices. A proprietary manufacturing process has already been successfully developed and deployed for lower volume production. This project will now focus on developing and scaling the next generation deposition technology to enable larger commercial volumes. The final goal of this project is to prepare and submit the clinical results for regulatory approval and reimbursement consideration for using BioBridge as an interventional device for treating lymphedema. Having a successful outcome at the completion of this study would provide a viable, safe and much needed treatment approach to this common disease that so heavily impacts breast cancer survivorship. It will also provide the framework for better comprehension of this disease and the role that regenerative medicine can play in future strategies to treat and prevent lymphedema.