Trachea Organ Regeneration
Diseases of the trachea may result from tumour, trauma, congenital defects or iatrogenic injury for example following intubation or rigid bronchoscopy. These conditions may lead to tracheal stenosis (narrowing), tracheomalacia (floppiness of the trachea which may result in collapse of the trachea during breathing) or surgical intervention to remove some or all of the trachea (e.g. tumour excision).
Severe airway diseases, may lead to life-threatening airway obstruction with resultant high associated morbidity and mortality rate if not treated successfully. Currently patients are subjected to repeated, limited efficacy, surgical interventions such as stent insertions which ultimately have a high incidence of failure. Tissue engineered autologous stem cell seeded tracheal transplants could offer a cost-effective one-off curative treatment for these patients.
Donated human trachea are processed using Videregen’s proprietary technology to remove cells and cellular remnants. Autologous mesenchymal stromal cells and airway epithelial cells are used to reseed the decellularised tracheal scaffold, which is then used to replace the diseased portion of the patients trachea.
GMP manufacture capability is in place for the trachea replacement product and the product has all required regulatory and ethical approvals necessary to commence clinical trials in the UK.