Geron aims to be first in human trials with ESCs – Gains FDA Approval

by Jennifer Lahl, CBC President on January 28, 2009

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.


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