2017 Volume 63 Issue 5 Pages 183-188
A resection of the trachea is sometimes required because of the malignancies or stenosis due to traumas or inflammatory diseases. The consequent tracheal defect causes cosmetic and functional problems, and thus early closure of the stoma is usually expected. However, the closure of a huge stoma is still challenging. In order to establish a safe and easy procedure for tracheal reconstruction, we have developed an artificial trachea over the past few decades. Our in situ regeneration-inducible artificial trachea composed of a porcine collagen sponge and polypropylene framework has been proven to have a long-term safety and efficacy by previous non-clinical studies. Further, a clinical study using the artificial trachea conducted under an approval of institutional review board has achieved a successful outcome of tracheal reconstruction. Now, we are running a multi-institutional, investigator initiated clinical trial of tracheal reconstruction using our in situ regeneration-inducible artificial trachea intending to investigate its safety and efficacy. The patients with a stoma unable to be reconstructed with existing treatment options, or with malignancies affecting no less than a half of the tracheal cartilage as well as three tracheal rings will be included in this trial. With results of this trial, we are expecting to have an approval of the artificial trachea as a new medical device under Japan's Pharmaceutical and Medical Device Law.
