BME 382J Sample Exam #2 Problem Daniel Rothenberg You have discovered a new strain of bacteria on a crashed meteorite.

Upon further study of this bacterium, you find that it has the ability to mutate its DNA to become any tissue in the human body. This stem cell bacteria reacts in the same way that pluripotent embryonic stem cells would to growth factors and mechanical signals. This bacteria strain has not been found anywhere else in the world and appears to be foreign to earth. 1) List 3 challenges you must overcome to get this new stem cell bacteria therapy into the clinic FDA Approval Scale up Transition from in vitro to in vivo Insurance company acceptance Long shelf-life of protein

2) How can you amplify the population and ensure that not all the cells die off after a few passages? Explain Cryogenically freeze some of the cells to save them for later. Freezing cells effectively puts them in suspended animation, and they can be reanimated at later point in time in the same state in which they were initially frozen.

3) What types of tissues will arise from growing these cells under the following mechanical stresses? a) Shear: endothelial cells b) Compression: cartilage, bone c) Tension: muscles, ligaments 4) Why will this cell-derived therapy be difficult to translate to the clinic? Most products approved by the FDA for clinical translation are acellular. Having live cells in the product makes it more difficult to gain approval.