SBIR Phase I: Development of a Tissue Engineered Trachea

这个小企业创新研究（SBIR）第一阶段项目建议开发一种由合成纳米纤维制成的人工气管，并将其植入患者体内。在手术室使用一次性的封闭系统接种室。 对于可能由大肿瘤或创伤性损伤引起的大气管病变，目前还没有市售的解决方案。 本项目的研究目标是开发一种可重复的干细胞接种方案，确定接种气管移植物与非接种气管移植物的有效性，并表征植入特定时间点后新气管的机械性能。 预期干细胞接种气管移植物将被患者完全接受？该项目更广泛的影响/商业潜力在于，该项目的结果不仅将挽救目前没有其他可行选择的气管病变患者的生命，而且将推进再生医学领域，并对其他组织工程器官的商业开发具有重大利益。 通过用合成聚合物制造支架，我们能够为身体中几乎任何类型的器官创建框架，从血管到气管再到皮肤。 如果我们能开发出一种强大，快速，有效的方法，在这些支架上接种来自手术室中预期患者的干细胞，那么我们就有可能为任何患者重建器官，而没有排斥反应的风险，不需要器官捐赠者，也不需要等待名单。 修复或再生组织/器官的能力解决了估计每年数千亿美元的市场规模。 该平台技术将创造再生医学的新范式，并将患者护理提升到新的水平。

This Small Business Innovation Research (SBIR) Phase I project proposes to develop an artificial trachea made from synthetic nanofibers that is seeded with the patient?s own stem cells in the operating room using a disposable, closed system seeding chamber. There currently are no commercially available solutions to large tracheal lesions that may occur from large tumors or traumatic injuries. The research objectives of this project are to develop a reproducible stem cell seeding protocol, determine the efficacy of seeded tracheal grafts versus non-seeded tracheal grafts and characterize the mechanical properties of the neotrachea after implantation for specified time points. It is anticipated that the stem cell seeded tracheal graft will become fully accepted by the patient?s body and facilitate the body to regenerate a new trachea on the implanted nanofiber scaffold.The broader impact/commercial potential of this project is that the results of this project will not only save the lives of patients with tracheal lesions that currently have no other viable options, but it will advance the field of regenerative medicine and have significant benefits on the commercial development of other tissue engineered organs. By creating scaffolds with synthetic polymers, we are able to create the framework of nearly any type of organ in the body ranging from blood vessels to tracheas to skin. If we can develop a robust, fast, efficient method to seed these scaffolds with stem cells from the intended patient in the operating room, then we have the potential to recreate organs for any patient without the risk of rejection, without the need for an organ donor, and without the need to be a waiting list. The ability to repair or regenerate tissue/organs addresses a market size estimated to be several hundred billion dollars annually. This platform technology will create a new paradigm of regenerative medicine and advance patient care to new levels.