FDA approves first trial involving the use of embryonic stem cells in humanscreated 7/31/2010 - 8:59 am, updated 7/31/2010 - 10:11 am by Chris |
Here and here is some background on embryonic vs. adult stem cells. Despite that information, the FDA has determined the show must go on. via lifenews.com:
Washington, DC (LifeNews.com) -- The Obama administration has approved the bid by cloning company Geron to undertake the first trial involving the use of embryonic stem cells in humans. They have never been used before in people because the cells cause tumors and have been plagued by immune system rejection issues when tried in animals.
Scientists and pro-life advocates say human embryonic stem cells are not ready for trial because problems associated with the cells in animals haven't been solved.
The Food and Drug Administration had initially placed the trial on hold but Geron indicated today that the agency is now allowing it to proceed with an early stage trial on a stem cell therapy for acute spinal cord injury.
The FDA placed a hold on the trial last August, when evidence showed Geron's GRNOPC1 encountered safety issues when used in animal studies. Geron's own data showed higher frequency of small cysts within the injury site in the spinal cord of animals injected with the embryonic cells.
“We are pleased with the FDA’s decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed,” said Thomas B. Okarma, Geron's president, in a public statement today. The company's stock rose in value following the announcement.
Previously, Dr. John A. Kessler, chairman of neurology and director of the stem cell institute at Northwestern University, said the first application from Geron for the embryonic stem cell trial was flawed.
“We really want the best trial to be done for this first trial, and this might not be it,’’ he said at the time.
Responding to the news today, Dr. David Prentice, a former biology professor at Indiana State University who is now a fellow at the Family Research Council, tells LifeNews.com those concerns should still exist.
"It's unfortunate that the FDA has released Geron from the safety hold on their embryonic stem cell trial," he said. "Even many pro-embryonic stem cell scientists have expressed reservations about Geron's trial, that it is not proven even in rats. The concern for many of us is that Geron is endangering patient's health and very lives, to make a political point and increase their stock price."
Prentice also said the trial's approval makes it so the use of adult stem cells, which are safely helping patients battling more than 100 diseases and conditions already, continue to be ignored.
"In the meantime, adult stem cells have already shown published scientific evidence for safety and successful repair of spinal cord injury in patients. Only adult stem cells offer both an ethical and successful path to healing," he said.
Quoting from one of the background articles above, "These latest results show that the ES cells need to be genetically modified and extensive manipulation in vitro before they can be transplanted safely." Literally, that would mean creating babies for the sole purpose of being destroyed.
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