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1 Surname_________ Name_____________registration (matricola)_____________ Technologies for regenerative medicine - Prof. Manuela T. Raimondi 2018.09.11 - examination theme. Read the text below and answer, point by point, to the related questions. Bioartificial trachea A bioartificial trachea was developed in vitro. The organ was taken from a human cadaver and it was decellularized by using detergents. For the recellularization were used a co -culture of epithelial and mesenchymal stem cells (MSC), expanded in vitro and the latter also induced to differentiation towards the cartilaginous phenotype through conditioning with differentiaton factors. The recellularized trachea is an empty cylinder with thickness s. It was cultivated in vitro using a rota ting bioreactor, which allows both the internal and external surfaces of the cellular construct to be maintained wet with a layer of culture medium saturated with oxygen at the concentration C m. The current conventional therapy for the trachea is replacement with an artificial prosthesis. Answer briefly to the questions in the table (points 5/33): What is the therapeutic product? The decellularized trachea, recellularized with epithelial and MS cells What are the elements that identify the therapeutic product as a PTC? The main therapeutic agent are the cells, obtained after "non-minimal manipulation" consisting in cell isolation and cell expansion In what phase of the regulatory process for new PTCs can this PTC be localized? in vitro What are the standards that apply in this stage of the PTC process of development? Good Laboratory Practice (GLP) What are the risks associated with this PTC (immunogenic, tumour, teratoma, infection, toxicity)? Immunological rejection: Yes. We do not know the cell source Tumor formation YES…