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26.09.2022 Esercitazione 3 (TMR[1]) 1. 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 the synthetic breast implants. Answer briefly to the questions in the table: What is the therapeutic product? What are the elements that identify the therapeutic product as a PTC? In what phase of the regulatory process for new PTCs can this PTC be localized? What are the standards that apply in this stage of the PTC process of development? What are the risks associated with this PTC (immunogenic, tumour, teratoma, infection, toxicity)? r R D C 2. Cell expansion in a monolayer A new therapy for osteoarthritis is based on the use of chondrocytes , isolated, expanded in culture and repetitively injected into the patients. Cells are expanded into monolayer on the bottom of petri dishes. The cell monolayer is kept in static culture covered with one layer of culture medium with thickness s. The partial pressure of oxygen present in the atmosphere of the incubator…