SBIR-STTR Award

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.

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.