Well I am way behind in blogging on this story. Mainly because it broke when I was in Washington DC last week. But this was certainly news coming down the pipeline as Geron has been making noise for years that they would be first to begin human embryonic stem cell clinical trials.
Here are some headlines covering this story:
The New York Times, F.D.A. Approves a Stem Cell Trial
The Newswire Announcement, Geron Receives FDA Clearance to Begin World’s First Human Clinical Trial of Embryonic Stem Cell-Based Therapy
Of course this is the first EVER human embryonic trial, and the reason the FDA had yet to approve the clinical trial was because of safety obstacles. To date, escr has produced tumors in the lab, and therefore was not deemed safe.
So, this first trial will be all about SAFETY and NOT EFFICACY of the treatment. And I hope and imagine the guidelines of the trial are very strict, so if safety is not proven, the trial will stop.
I’ll keep this top of my radar and report back to you.
- Jennifer Lahl, MA, BSN, RN, is founder and president of The Center for Bioethics and Culture Network. Lahl couples her 25 years of experience as a pediatric critical care nurse, a hospital administrator, and a senior-level nursing manager with a deep passion to speak for those who have no voice. Lahl’s writings have appeared in various publications including Cambridge University Press, the San Francisco Chronicle, the Dallas Morning News, and the American Journal of Bioethics. As a field expert, she is routinely interviewed on radio and television including ABC, CBS, PBS, and NPR. She is also called upon to speak alongside lawmakers and members of the scientific community, even being invited to speak to members of the European Parliament in Brussels to address issues of egg trafficking; she has three times addressed the United Nations during the Commission on the Status of Women on egg and womb trafficking.