SBIR Phase II: Development of a Tissue Engineered Trachea

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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.