19 07 18

Pagina 1

1 Surname_________ Name_____ ________registration (matricola)_____________ Technologies for regenerative medicine - Prof. Manuela T. Raimondi July 17, 2018 - examination theme. Read the text below and answer, point by point, to the related questions. Cell expansion in a monolayer A new therapy for osteoarthritis is based on the use of mesenchymal stem cells (MSC), isolated from the bone marrow, expanded in culture and injected into the patients . Cells isolated from the bone marrow are expanded into monolayer on the bottom of a 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 is Po . The flow of oxygen on the cells is known and equal to Jc. The diffusion coefficient of the oxygen in the culture medium at 37 ° C is equal to D. The hypothesis of plane symmetry can be assumed for the concentration of oxygen in the medium. This therapy has been successfully tested on the first 10 human patients and the conventional therapy is arthroplasty with an artificial prosthesis. Answer briefly to the questions in the table (points 5/33): What is the therapeutic product? 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, expansion and seeding In what phase of the regulatory process for new PTCs can this PTC be localized? Human clinical trial of phase I, also known as pilot study What are the standards that apply in this stage of the PTC process of development? Good Manufacturing Practice (GMP) for the production of the PCT; Good Clinical Practice (GCP) for the clinical trial What are the risks associated with…