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

乳腺癌相关淋巴水肿手术解决方案的前瞻性评估

• 批准号: 9547331
• 负责人: Michael Vitoldovich Paukshto
• 金额: $ 99.82万
• 依托单位: FIBRALIGN CORPORATION
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9547331
• 关键词: Address; Advanced Development; Affect; Aftercare; Animals; Autologous; Blinded; Breast Cancer survivor; Breast Cancer survivorship; Cell-Matrix Junction; Chronic; Chronic Disease; Clinical; Clinical Research; Collagen; Comprehension; Cutaneous; Data; Deformity; Deposition; Dermal; Development; Devices; Diagnostic Neoplasm Staging; Disease; Endothelial Cells; Enrollment; Evaluation; Exclusion Criteria; Family suidae; Funding; Future; Goals; Grant; Head; Histologic; Human Resources; Ii-Key; Infection; Intervention; Investigation; Left; Life; Limb structure; Lymphatic; Lymphatic vessel; Lymphedema; Measurable; Measures; Membrane; Memorial Sloan-Kettering Cancer Center; Missouri; Modeling; Monitor; Multi-Institutional Clinical Trial; Natural regeneration; Operative Surgical Procedures; Outcome; Outpatients; Output; Pain; Pathology; Patients; Phase; Play; Preventive Intervention; Procedures; Process; Production; Protocols documentation; Punch Biopsy; Quality of life; Radiation therapy; Randomized; Regenerative Medicine; Research; Role; Savings; Skin; Small Business Innovation Research Grant; Specific qualifier value; Statistical Data Interpretation; Swelling; System; Systems Development; Technology; Testing; Thick; Time; Tissues; Universities; anticancer research; arm; base; clinical investigation; cohort; commercialization; design; effective therapy; high risk; human subject; implantation; improved; inclusion criteria; innovation; lymph nodes; malignant breast neoplasm; manufacturing process; migration; minimally invasive; nanofibrillar; nanopattern; neglect; next generation; novel; novel therapeutic intervention; outcome prediction; pre-clinical; preclinical study; prevent; prospective; prototype; recruit; repaired; scaffold; scale up; secondary endpoint; success; technology research and development; treatment response; treatment strategy

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.

项目总结/摘要 乳腺癌相关性水肿手术治疗方案的前瞻性评价 拟议项目将完成其余的关键研究和技术要求， 需要将一种治疗继发性水肿的突破性介入装置商业化 --一种慢性和使人衰弱的疾病，目前没有治愈方法，估计影响15-30%的 乳腺癌幸存者 乳腺癌的分期和治愈通常需要手术，有或没有放射治疗 疗法这些干预措施虽然可以挽救生命，但有时会破坏足够的淋巴功能， 乳腺癌幸存者的手臂会出现疼痛肿胀，频繁的疼痛， 感染，可能危及生命，并最终导致组织中不可逆的结构变化， 导致严重畸形，功能和生活质量严重下降。 BioBridge是一种新型的线状胶原蛋白支架，旨在支持新的健康组织再生。 淋巴管，将修复患病组织的患者患有乳腺癌相关 水肿根据早期成功的大型动物研究的结果，假设 一种新的装置将提供有史以来第一个治疗，以可测量地恢复淋巴功能，减少 缓解疼痛，提高患者的生活质量。 该项目的主要目标是评估BioBridge在人类受试者中的有效性。定义的协议具有 已开发用于测试120名患有I期或II期乳腺癌相关疾病的受试者 由斯坦福大学领导的一项多中心临床研究中的水肿。成功完成后， 该研究将产生关键的定量数据，这些数据将证实生物桥的能力， 逆转疾病，并将其疗效与现有的水肿治疗策略进行比较。 另一个目标是扩大制造技术，以支持生物桥的商业生产 装置.已经成功开发和部署了专有的制造工艺 低产量生产。该项目现在将专注于开发和扩展下一代 沉积技术，以实现更大的商业量。本项目的最终目标是准备 并提交临床结果供监管部门批准和报销考虑， BioBridge作为治疗水肿的介入器械。 在这项研究完成时取得成功的结果将提供一个可行的，安全的， 需要治疗这种严重影响乳腺癌生存率的常见疾病。 它还将提供一个框架，更好地理解这种疾病和再生的作用， 药物在未来治疗和预防水肿的策略中发挥作用。