Tracheal regeneration using an artificial trachea: a multicenter clinical trial

Abstract

A tracheal resection is sometimes required because of malignancies or stenosis due to traumas or inflammatory diseases, and the consequent tracheal defect causes cosmetic and functional problems. Although early closure of the stoma is expected, the closure of a huge stoma is still challenging. We have developed an artificial trachea according to the concept of in situ tissue engineering in the past few decades, aiming to establish a safe and easy procedure for tracheal reconstruction. The long-term safety and efficacy of our in situ regeneration-inducing artificial trachea composed of a porcine collagen sponge and polypropylene framework have been confirmed by previous non-clinical and clinical studies. In order to obtain approval for our in situ regeneration-inducing artificial trachea as a new medical device under Japan’s Pharmaceutical and Medical Device Law, we are now running a multi-institutional, investigator-initiated clinical trial of tracheal reconstruction using our artificial trachea. Patients with a stoma unable to be reconstructed with existing treatment options, or with malignancies affecting no less than half of the tracheal cartilage as well as three tracheal rings, will be included in this trial. When the safety and efficacy of the artificial trachea are proven with this trial, we plan to apply for approval of the artificial trachea as a new medical device.