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？在手术室中使用一次性的、封闭的系统播种室。对于可能由大肿瘤或创伤性损伤引起的气管大病变，目前还没有商业上可用的解决方案。本项目的研究目标是开发一种可重复的干细胞播种方案，确定有籽气管移植物与无籽气管移植物的疗效，并在特定时间点表征新气管植入后的力学特性。预计干细胞植入气管移植物将被患者完全接受。并在植入的纳米纤维支架上促进人体再生新的气管。该项目的更广泛的影响/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，而且将推动再生医学领域的发展，并对其他组织工程器官的商业开发具有重大益处。通过用合成聚合物制造支架，我们能够制造人体几乎任何类型器官的框架，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，在手术室里用预定病人的干细胞植入这些支架，那么我们就有可能为任何病人重建器官，而不会有排斥的风险，不需要器官捐赠者，也不需要等待名单。修复或再生组织/器官的能力每年的市场规模估计为数千亿美元。该平台技术将创造再生医学的新范式，并将患者护理提高到新的水平。

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.