Every innovation in medicine is met with a mixture of excitement, expectation and a certain degree of apprehension. Nowhere is this more apparent than in the field of cell-based therapy, i.e. the application of cells to patients, locally or systemically, for therapeutic purposes. Excitement and expectation are generated by the many preclinical and early clinical studies that continue to reveal the enormous potential of regenerative medicine. The recent successful implantation of a large airway, engineered ex vivo from a donor trachea, into a patient as a replacement for a stenosed left main bronchus (post-tuberculosis), is a case in point. (1) Likewise, reports of dramatic functional improvement in children with cerebral palsy treated with autologous cord-blood stem cells at Duke University warrant our serious consideration. (2) And this is just the beginning. It is believed that cell-based therapy will have a significant positive impact on virtually every organ system in the body, and that the extent of this impact is limited only by the limits of our scientific creativity. However, these innovations come with numerous complex and challenging moral and ethical issues, including for example those surrounding embryonic stem cells, stem cell banking and the ethics of cloning (therapeutic versus reproductive). And of course, patient safety needs to be ensured.