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**Videregen tracheal replacement** is a patient-specific, tissue-engineered airway graft intended to replace a severely diseased tracheal segment in severe tracheal stenosis or tracheomalacia. The advanced therapy medicinal product uses a donated human trachea that is decellularised to create an acellular structural scaffold, then recellularised with expanded autologous mesenchymal stromal cells and, in the intended product configuration, airway epithelial cells. The approach is designed to restore airway structure while reducing allogeneic cellular immunogenicity and avoiding chronic anti-rejection therapy. Videregen developed the product with UK clinical and manufacturing partners; it received EU orphan designation for tracheal stenosis in 2016. ([ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1717))
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