Year 3 (NCE)
The development candidate is an airway construct, composed of a customized tissue-engineered biologic scaffold, including a decellularized tracheal construct which is repopulated with cells from the patient. Constructs are prepared in a dedicated bioreactor according to standard operating procedures. The target population is patients with airway stenosis due to traumatic, inflammatory, or idiopathic causes, who have failed conventional therapies. Individuals with these problems presently require frequent hospitalization. Currently, ~200 adults annually present in California with acquired tracheal stenosis, and require surgery and/or stents. Surgery can lead to further scar formation, and stents are uncomfortable and can migrate. Thus, neither stents nor conventional surgery fully addresses the need. IND-enabling studies performed include refine optimal surgical implantation techniques, determine the duration and fate of recellularized grafts, and assess potential efficacy.