By Susan Brinkmann, OCDS
The Food and Drug Administration (FDA) is delaying a bid by biotech company Geron Corp. to become the first to conduct human trials with embryonic stem cells, pending review of new studies.
According to a report by LifeNews.com, Geron had planned to begin the trials this summer on eight to 10 patients with spinal chord injuries. However, officials announced yesterday that the FDA was delaying the trials pending review of new data from studies of the therapy, known as GRNOPC1, in its use with animals.
Many scientists don’t believe human embryonic stem cells are ready for use in humans because problems such as causing tumors and immune system rejection have yet to be resolved. These cells are also very controversial because they result in the destruction of human life. In addition, promising new therapies involving adult cells have convinced many scientists that embryonic stem cells are no longer needed to produce breakthrough medical treatments.
Evan Snyder, a neuroscientist who heads up the stem cell research center at the Burnham Institute for Medical Research in San Diego, is one of those scientists who question whether embryonic stem cell therapies are ready for human testing.
“There’s a lot of debate among spinal cord researchers that the pre-clinical data itself doesn’t justify the clinical trial,” said Snyder, who is also involved in the use of neural stem cell therapies.
Snyder says the mice Geron used to conduct pre-human trial research had more excessive injuries that scientists would normally prefer to see prior to trying the procedure on human patients.
He suggests that Geron should have done experiments involving larger animals before seeking FDA permission to use the controversial embryonic stem cells in humans.
Bioethicst Wesley J. Smith expressed concern in January of this year that the FDA was not requiring enough proof from Geron that its experiments were ready for human trials.
“Why wouldn’t the FDA require such work as they usually do in approving new drugs? Indeed, when the FDA said no to Geron last year, I expected successful larger animal work would be a necessary precondition to obtaining the FDA’s approval,” he said.
Because the FDA’s sudden decision to go ahead with the trials came shortly after President Obama took office, he worried that the decision may have been political.
It is not known how long the FDA review will take before a new decision is reached.
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