BIOtrachea · Biomaterials for Tracheal Replacement in Age-related Cancer via a Humanly Engineered Airway

Age-related cancers, especially of the trachea, are neoplastic lesions that significantly impact upon the lives of thousands of European patients each year. Unfortunately, most present with inoperable lesions for which median survival is less than 12 months. Based on our previous clinically successful experiences with in vivo completely tissue engineered tracheal replacement in benign tracheal diseases, we recently applied this technology in 2 patients with otherwise inoperable primary tracheal cancers. The successful observed outcome confirms the unique opportunity to scale-up an effective therapeutic approach into a widely accessible clinical technology, which could enhance not only the quality of life but even cure otherwise untreatable patients. However, a limitation of our current technology is the time it takes to re-populate the decellularized trachea. This may prove critical in the case of cancer patients. Further, the size of the transplant is currently limited due to the fact that the transplanted tissue needs to be efficiently and rapidly vascularised to prevent necrosis in vivo. To surmount these limitations, we aim to: i) improve our current technique of in vivo tissue engineering human tracheae in a small number of patients and subsequently begin a formal clinical trial, ii) develop pharmacological approaches to activate endogenous stem cells, stimulate tissue regeneration and vascularisation in situ, iii) develop a synthetic tracheal scaffold using a novel nanocomposite polymer as alternatives to natural human scaffolds and iv) develop good medical practice manufacturing process for safe, efficient and cost effective commercial production. This research project is aimed to define a robust airway implantation technique assuring a better outcome for thousands of patients each year. Moreover, we aim to use these results as a starting point to develop clinical approaches that could improve the treatment of age-related cancers of other hollow organs.