Geron Could Resume Stem Cell Trial

San Francisco Business Times, October 30, 2009

The use of embryonic stem cells has generally been a subject of ethical discussion and debate. On the one hand the argument is made that sacrificing a human life should never be performed to potentially save another. On the other hand some believe that the fertilized eggs from which embryonic stem cells are extracted from are not human life and therefore there should be no issue. Unfortunately, such discussions have overshadowed the public image of "stem cells", and examination of potential medical adverse effects of embryonic stem cells often is ignored in public discussions. One example of politics overshadowing medical facts may be the hastily granted FDA approval of Geron to begin human clinical trials with embryonic stem cells, an approval that was granted on the same day as President Obama's Inauguration and then subsequently retracted.

The company Geron, located in Menlo Park and originally founded by Michael West, has been working in the area of regeneration for more than a decade. It was Geron that controls the intellectual property for the life-extending molecule telomerase, and it also was Geron that funded the studies which resulted in creation of human embryonic stem cells. One product that Geron chose to develop is human embryonic stem cells that are differentiated into nervous system cells, for use in treatment of patients with spinal cord injury. While it is common knowledge to scientists but not to the public that embryonic stem cells cause cancer, Geron through treating the cells with various chemicals, believes it has generated a cellular product that does not pose the risk of cancer.

After numerous animal experimentations, including small and large animals, Geron was granted FDA approval for a Phase I clinical trial in 10 patients that had spinal cord injury within 7-10 days. This approval was linked to political motives by some. According to Robert N. Klein, the chairman of California's $3 billion stem cell research program, "I think this approval is directly tied to the change in administration," said He said he thought the Bush administration had pressured the F.D.A. to delay the trial.

The approval was withdrawn in August, 2009 before any patients were treated. The trial was placed on what is called "clinical hold", meaning that patients cannot be treated until more data is submitted. This was because some animals in the studies were seen to develop abnormal cysts. In the press release today, Geron stated that subsequent to their recent discussions with the FDA, they believe they will have sufficient new animal data to allow for continuation of the trial sometime in thei third quarter of 2010.