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1 Surname________________ Name ________________registration (matricola)_____________ Technologies for regenerative medicine - Prof. Manuela T. Raimondi Examination theme – 4 July 2017 Read the text below and answer, point by point, to the related questions. Cell therapy for critical size bone defects A new cell therapy to regenerate tissue in a bone defect of critical size is based on the use of mesenchymal stromal cells. In this therapeutic strategy, cells are obtained, expanded in vitro, seeded into a biocompatible and biodegradable hydrogel at a cell density of 1 million cells/ml. The product is injected in a bone spherical defect of the patient to obtain bone tissue regeneration. The defect has radius R, and the nutrient concentration outside the defect is Cin The minimum concentration to guarantee sufficient nutrient is cmin = cin/10. Cell consume the nutrient at a constant rate V. To date, the first ten human patients have been treated using this therapeutic strategy. Answer briefly to the questions in the table (points 5/33): What is the therapeutic product? The hydrogel loaded with the MSC 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? Clinical trial (phase I) What are the standards that apply in this stage of the PTC process of development? Good Manufacturing Practice (GMP) for its production; Good Clinical Practice (GCP) for the clinical trial What are the risks associated with this PTC (immunogenic, tumour, teratoma, infection, toxicity)? Since the cell source is not specified in the text, the risks are all the five main…