SBIR Phase I: Biologic Filler for Regenerating Tissue Following Breast Conserving Surgery

SBIR 第一阶段：用于保乳手术后组织再生的生物填充剂

• 批准号: 1913626
• 负责人: Theodore Puls
• 金额: $ 22.49万
• 依托单位: GENIPHYS, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2020-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1913626&HistoricalAwards=false
• 关键词: SBIR; Phase; Biologic; Filler; Regenerating

This SBIR Phase I project will address key hurdles for commercialization of an injectable breast tissue replacement for use immediately following breast conserving surgery, otherwise known as lumpectomy. Surgeons using this procedure today have limited options for predictably restoring normal breast size, shape, and consistency following tumor removal. Because of this, many women are left with breast deformities or must undergo multiple surgical procedures. These issues compromise their psychological well-being and quality of life and increase healthcare costs. With these challenges in mind, this project will evaluate the ability of a patented, liquid, fibril-forming collagen to serve as an injectable, breast tissue replacement. Upon injection, this liquid biopolymer self-assembles into a physically stable and persistent natural fibrillar scaffold, meaning it can be used to fill patient-specific tissue voids. Project results will provide early-stage preclinical evidence of this biopolymer's effectiveness for filling and regenerating breast tissue in a large animal lumpectomy model. If successfully translated to the clinic, this therapy would provide breast cancer surgeons with a much-needed regenerative breast tissue solution. This in turn, would boost surgeons' confidence when working to achieve complete tumor removal, improve quality of life for breast cancer survivors, and decrease overall costs of care. The liquid collagen polymers evaluated in this proposal preserve several natural features of the collagen protein as it exists in the body, thus giving rise to three key advantages. First, this biomaterial has the ability to rapidly transition from liquid to solid, forming natural collagen-fibril scaffolds just like those in the body's tissues. Second, it is amenable to customization and advanced biofabrication with tailorable geometries, fibril architectures, and mechanical properties. And finally, these scaffolds stably integrate and persist in vivo, inducing site-appropriate tissue generation without evoking immune or inflammatory response. This project seeks to overcome technical hurdles associated with identifying compatible and scalable sterilization and manufacturing processes for this unique, liquid biomaterial. Additionally, project activities will seek to specify biopolymer formulations that support surgeon ease-of-use, provide efficacy for breast tissue replacement, and do not interfere with standard clinical practices (e.g. radiation and re-excision procedures). The outcomes of this proposal will provide valuable proof-of-concept for a viable medical-grade manufacturing process and early preclinical validation that these collagen polymers can address breast cancer patient-specific needs. Finally, this project will lay the foundation for this natural collagen polymer to serve as an enabling tool for next generation personalized regenerative medicine therapies.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

该SBIR I期项目将解决可注射乳腺组织替代物商业化的关键障碍，该替代物可在保乳手术（也称为乳房肿瘤切除术）后立即使用。今天使用这种手术的外科医生在肿瘤切除后可预测地恢复正常乳房大小，形状和一致性的选择有限。正因为如此，许多妇女留下乳房畸形或必须接受多次手术。这些问题损害了他们的心理健康和生活质量，并增加了医疗费用。考虑到这些挑战，该项目将评估获得专利的液体原纤维形成胶原蛋白作为可注射乳房组织替代品的能力。注射后，这种液体生物聚合物自组装成物理稳定和持久的天然纤维状支架，这意味着它可以用于填充患者特定的组织空隙。项目结果将提供这种生物聚合物在大型动物乳房肿瘤切除术模型中填充和再生乳房组织的有效性的早期临床前证据。如果成功地转化为临床，这种疗法将为乳腺癌外科医生提供急需的再生乳腺组织解决方案。这反过来又会增强外科医生在实现肿瘤完全切除时的信心，提高乳腺癌幸存者的生活质量，并降低整体护理成本。本提案中评估的液体胶原蛋白聚合物保留了胶原蛋白在体内存在的几种天然特征，因此具有三个关键优势。首先，这种生物材料具有快速从液体转变为固体的能力，形成天然的胶原纤维支架，就像人体组织中的支架一样。其次，它适合定制和先进的生物织物，具有可定制的几何形状，原纤维结构和机械性能。最后，这些支架在体内稳定整合并持续存在，诱导适当部位的组织生成，而不会引起免疫或炎症反应。该项目旨在克服与确定这种独特的液体生物材料的兼容性和可扩展的灭菌和制造工艺相关的技术障碍。此外，项目活动将寻求指定生物聚合物配方，以支持外科医生的易用性，为乳房组织置换提供有效性，并且不干扰标准临床实践（例如，放射和再次切除手术）。该提案的结果将为可行的医用级制造工艺和早期临床前验证提供有价值的概念验证，这些胶原蛋白聚合物可以满足乳腺癌患者的特定需求。最后，该项目将为这种天然胶原蛋白聚合物奠定基础，使其成为下一代个性化再生医学疗法的有利工具。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。