"The report today that the FDA has approved the first human clinical trial of an embryonic stem cell-based intervention raises important ethical considerations, but not only, or even primarily, because what is at issue is an embryonic stem cell-based intervention. Although deep-seated disagreements about the ethics of embryo research surround the interest in this study, we need to focus as well on this being the first human trial of its kind. Any "first in human beings" medical experiment requires the highest level of moral scrutiny and oversight. At this point it is critical that every effort be made to protect the welfare and rights of the patients who will be approached to be these human subjects. A good place to start would be by NOT referring to this study as a trial of a stem cell-based therapy, as Geron has described it, but rather as a stem cell-based intervention whose therapeutic benefits in humans has not yet been studied. It is also important to emphasize that this trial offers little prospect of clinical improvement to the very first patients who will participate in the safety phase of the research."
Ruth Faden, Ph.D., M.P.H.
Philip Franklin Wagley Professor of Biomedical Ethics; Director, Johns Hopkins Berman Institute of Bioethics