TETRA is an international collaborative clinical research and development project involving thirteen European organisations funded via the EU's Horizon 2020 programme. The regenerative medicine project is focussed on addressing the significant clinical need of patients suffering from tracheal (windpipe) diseases that lead to breathing and respiratory problems and result in a very poor quality of life for many sufferers.
Tracheal diseases leading to narrowing of the airway (making it difficult to breath) can be caused by cancer, trauma or infection. As well as reducing a patients quality of life these indications can lead to further complicated illnesses and ultimately death if not treated successfully. Currently patients are subjected to repeated surgical interventions, such as stent insertions (to keep the trachea open) which yield limited benefit and have a high incidence of failure. In contrast, the tracheal replacement approach to be clinically tested in the TETRA project involves repopulating a trachea 'scaffold' with a patient's own stem cells and is designed to be a one-off curative treatment without the need for a lifetime of anti-rejection drugs.
The TETRA clinical trial results are expected to lead to an European Marketing Authorisation application, with the launch of the world's first commercially available tissue engineered organ replacement product thereafter. The TETRA pivotal clinical trial, which will recruit patients in five clinical sites across Europe, will assess the safety and efficacy of the replacement trachea product. It will monitor how treatment reduces patients' need for additional interventions such as stents, as well as other factors such as the impact on quality of life. The project also involves scale-out of stem cell manufacture from an existing facility in London to a second GMP manufacturing site in Munich and in doing so establishing a pan-European supply chain. Validation of this production and supply system is an objective of the trial together with the effective demonstration of the product to patients and leading surgeons.