Year 2

Patients with congenital or acquired severe airway stenosis have few treatment options and a severely impaired quality of life. Current treatments are limited and include the need for multiple surgeries, which in most cases will not correct the problem. To advance preclinical investigations, studies were initiated to optimize protocols. New techniques and methods were developed and refined for cellular products, tracheal decellularization and recellularization, and a biorepository of characterized stem/progenitor cells and trachea for a tailored precision medicine approach. Fresh and decellularized tracheal sections were collected for histology, biomechanical testing, and quantitative PCR. The decellularization process was shown to remove 97% DNA and MHC proteins. Biomechanical strength testing demonstrated retention of necessary properties when decellularized scaffolds were compared with native tissue. For recellularization, autologous mesenchymal stem/stromal cells and epithelial cells were used and a consistent cell seeding protocol was developed with release criteria for in vivo studies. Surgical techniques for implantation have been optimized, and clinical parameters monitored including structure integrity. Based on the outcomes, to date, results suggest no evidence of rejection or structural failure.