SBIR Phase II: Development of a Tissue Engineered Trachea

SBIR 第二阶段：组织工程气管的开发

• 批准号: 1456341
• 负责人: Jed Johnson
• 金额: $ 62.46万
• 依托单位: Nanofiber Solutions
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-01 至 2017-04-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1456341&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Development; Tissue

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is focused on developing a customizable tissue engineered tracheal implant for tracheal transplantation and reconstruction surgery. Current surgical solutions for these patients are limited by problems with the availability of suitable cadaveric tissue, as well as with unsatisfactory long-term survival of the engrafted tissues due to issues with both revascularization and immune rejection. The combination of an inert biomaterial scaffold and autologous cells avoids any concerns with graft rejection, while allowing for the reliable production of tracheal grafts. Nanofiber Solutions expects this new device will enable as many as 6,500 life-saving procedures annually. A successful Phase 2 project will demonstrate long-term performance of the nanofiber tracheal implant and the mechanisms of action in a large animal model as well as a humanitarian device exemption (HDE) application with the FDA to initiate a clinical trial. This trachea implant product addresses a $600 million dollar opportunity. Other tissue engineered products based on this technology platform address billions of dollars more in market opportunity.The proposed project is focused on developing a customizable tissue engineered tracheal implant for tracheal transplantation and reconstruction surgery. The trachea has challenging mechanical and biological requirements, and despite many attempts there currently is no fully functional artificial trachea. The fully synthetic tracheal scaffold is seeded with autologous stem cells harvested from the patient?s bone marrow. To prepare for an FDA submission and initial human clinical trials, we will accomplish three technical objectives in this Phase II work: 1) Optimize the use of a closed system, disposable seeding chamber to allow uniform cell seeding throughout the scaffold, 2) Develop a commercial manufacturing process for the production and placement of support ribs on the tracheal graft, and 3) Elucidate mechanisms of tracheal regeneration in vivo of intraoperatively seeded tracheal implants.

这个小企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力集中在开发用于气管移植和重建手术的可定制的组织工程气管植入物。目前用于这些患者的手术解决方案受到以下问题的限制：合适的尸体组织的可用性，以及由于血管重建和免疫排斥的问题而导致的移植组织的长期存活率不令人满意。惰性生物材料支架和自体细胞的组合避免了对移植物排斥的任何担忧，同时允许可靠地生产气管移植物。Nanofiber Solutions预计，这种新设备每年将实现多达6，500个救生程序。一个成功的第二阶段项目将证明气管植入物的长期性能和在大型动物模型中的作用机制，以及向FDA申请人道主义器械豁免（HDE）以启动临床试验。这种气管植入产品解决了6亿美元的机会。基于该技术平台的其他组织工程产品将带来数十亿美元的市场机会。拟议项目的重点是开发可定制的组织工程气管植入物，用于气管移植和重建手术。气管具有挑战性的机械和生物学要求，尽管有许多尝试，目前还没有功能齐全的人工气管。全合成的气管支架是用从病人身上采集的自体干细胞接种的？的骨髓。为了准备FDA申报和初步人体临床试验，我们将在第二阶段工作中实现三个技术目标：1）优化封闭系统、一次性接种室的使用，以允许在整个支架上均匀地接种细胞，2）开发用于在气管移植物上生产和放置支撑肋的商业制造工艺，3）阐明术中种植的气管植入物在体内的气管再生机制。