Skip to comments.FDA approves first human embryonic stem cell safety trial (3 days after Pres. Bush left)
Posted on 02/02/2009 7:07:22 PM PST by STARWISE
Federal regulators have green-lighted the first trial of an embryonic stem-cell treatment in humans.
The U.S. Food and Drug Administration (FDA) gave the go-ahead for Geron Corporation to start a phase I safety trial of its therapy GRNOPC1 for spinal cord injuries, the Menlo Park, Calif.based company announced today.
It first sought permission for the trial four years ago and spent much of the last year trying to satisfy the FDAs concerns about it.
"This marks the beginning of what is potentially a new chapter in medical therapeuticsone that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells, Thomas Okarma, Geron's president and CEO, said in a statement today.
The trial will involve up to 10 patients and will test whether it is safe to inject nerve cells from embryos into the site of their injuries, according to Geron. A study published in 2005 in the Journal of Neuroscience found that giving rats the injections seven days after a spinal cord injury improved their motor function.
Wise Young, director of The W. M. Keck Center for Collaborative Neuroscience at Rutgers University, hailed the FDAs decision, but says his expectations are tempered.
Its a big dealits a long time in coming. Theres a lot of hope riding on this, Young tells ScientificAmerican.com. But he cautions that people should not expect "a miraculous result" from this initial trial.
"I do believe cellular therapy will have a beneficial effect," he says, "but its very important to understand that were just starting. We have a long road to go.
Geron and FDA officials told The Wall Street Journal that it was a coincidence that the announcement came just three days after George Bush left the White House. Bush restricted federal funding of embryonic stem cell research.
"The FDA looks to the science on these types of issues, and we approve [such applications] based on a showing of safety," FDA spokesperson Karen Riley told the Journal. Political considerations have no role in this process."
Pres. Obama said during his campaign that he would lift the ban on federal funding of research on embryonic stem-cell lines produced after August 9, 2001. But he told CNN on January 18 that he may ask Congress to undo it.
Lawmakers passed legislation three times during the Bush administration that would have erased the limit and allowed research on stem cells from embryos at fertility clinics (with donors' consent) that would otherwise be discarded; Bush vetoed them all.
"I like the idea of the American people's representatives expressing their views on an issue like this," Obama told CNN.
That may not be a bad thing, Young says. If he were to reverse this on his own, it takes Congress off the hook.
Its much more important that Congress makes sure this doesnt happen again, he says. What is worrisome is that if Obama did just reverse the rule, stem cells would be a political football in Congress to trade for something else.
Its really important from the viewpoint of the advocacy community that legislation is passed so other presidents dont come in and say, I will forbid this.
God help us. We were blessed with a staunch protector of innocent human life ... life is a commodity now. God bless you, Pres. George Bush. Pray for America.
I hope this falls flat on its ass. The Embryonic Stem Cell Research gets us nowhere.
Very sad indeed. I do not think we will ever get a moral President as President Bush was. He believed in life and fought to preserve it and to protect it on all fronts.
The baby killers have been set loose!
Where is the photo of the wilting flowers? This is sad beyond belief.
This makes it sounds like they are taking cells directly from fetuses instead of limited lines grown in the lab - quite a change if that is really what they are doing.
Why is anyone surprised? ELECTIONS HAVE CONSEQUENCES.
Very sad. Experimenting on human embryos, reversing the Mexico City Policy so tax dollars are paid for abortions in other countries, etc..
Evil is spreading like wildfire.
Even more he was intelligent. He realized science was showing NON embryonic cells have more promise.
Their apathy towards getting the real story is part of what will doom us for several years.
“instead of limited lines grown in the lab”
In this case most likely contaminated lines. They have been for years. One of the many reasons that this type of research FAILS.
“I like the idea of the American people’s representatives expressing their views on an issue like this.” -BO
Roe v. Wade didn’t allow the American people to express their views on an issue like this.
Translation: "We have all these dead babies. There must be something we can do with them."
Why read Mary Shelley's Frankenstein when you can pick up a newspaper?
I for one would rather DIE than use an embryonic stem cell to prolong my life.
We've brought it on ourselves...
If they are ready for human trials now, they were doing the research during the entire Bush administration...they just were doing it without federal funding.
Pray for America!
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