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1"" Surname_________ Name_____ ________registration (matricola)_____________ Technologies for regenerative medicine - Prof. Manuela T. Raimondi 2018.02.08 - examination theme. Read the text below and answer, point by point, to the related questions. Regenerative therapy for the mammary gland Consider a therapy for mammary gland regeneration. The therapeutic strategy consists in the isolation of mesenchymal stromal cells from a biopsy of adipose tissue, their expansion in vitro, their differentiation towards adipocytes and their seeding into a solid sphere made of a hydrogel and the orthotopic implant of the cellularized construct. The construct has radius R, and the nutrient concentration outside the construct is constant and equal to C."The oxygen diffusion coefficient in the cellularised construct is equal to D. The minimum concentration to guarantee sufficient oxygenation of cells is cmin"="C/10. Cells consume oxygen at a constant rate, V. To date, this therapeutic product has been approved for commercialisation and it is in widespread clinical use. The only alternative for mammary reconstruction is implantation of synthetic breast implants. Answer briefly to the questions in the table (points 5/33): What is the therapeutic product? The cellularized construct What are the elements that identify the therapeutic product as a PTC? The main therapeutic agent are the MSC, obtained after "non-minimal manipulation" consisting in isolation, in vitro expansion and differentiation In what phase of the regulatory process for new PTCs can this PTC be localized? commercialization What are the standards that apply in this stage of the PTC process of development? Current Good Manufacturing Practice (cGMP) What are the risks associated with this PTC (immunogenic, tumour, teratoma,…