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 FDA’s concerns about it.
"This marks the beginning of what is potentially a new chapter in medical therapeutics—one 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 FDA’s decision, but says his expectations are tempered.
“It’s a big deal—it’s a long time in coming. There’s 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 it’s very important to understand that we’re 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.
It’s much more important that Congress makes sure this doesn’t 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.
It’s really important from the viewpoint of the advocacy community that legislation is passed so other presidents don’t come in and say, ‘I will forbid this.’”
Thank you for this article.. I was looking for the link yesterday .. and I’m now glad to have it... thanks
I guess we should take to the streets, singing :
O-bama, Heybama, bamabama-Hobama Heybama Hobama!
with apologies to Andrew Lloyd Weber
Question: would the FDA have been “ready” and made this decision and announcement on Jan. 23, 2008 ???
The term: “strains credulity” applies.
Obviously, the FDA has been researching this for years, but the bottom line is the LEADERSHIP AND GUIDANCE AT 1600 Pennsylvania.
Is it credible to believe there was NO collaboration with the incoming leftist admin on this ?
I would much rather be singing “Na na na na hey hey hey good bye” to Obama.
**“Na na na na hey hey hey good bye” **
the scum did that to President Bush, shows NO CLASS...
which I guess is ok, as NOBAMA has none, either!
;)
Not only naive, but stupid.
Proof positive that this man is NOT a Christian (’we know that we know that we know’) despite his public protestations and the MSM’s redundant repetition that he is...
God is in control.
God is in control.
And HolyO will answer to Him someday.
Especially ugly was his use of the term ‘previable fetuses’ when he opposed the Botched Abortion bill!!!!!!!!
Ending a human life for the "further off" hope that it might do some good some day, when there is all kinds of potential and success without ending that life MAKES NO SENSE.
There are definitely a number of issues that need to be discussed from a moral and ethical standpoint.
How is it a departure from Pres. Bush's standards?
Bush restricted federal funding of embryonic stem cell research.
Apparently Geron proceeded with the research without using federal funding.
Federal regulators have green-lighted the first trial of an embryonic stem-cell treatment in humans.
~~~~
Question: Would Pres. Bush’s FDA have done this ?
Trust me in that I totally understand your frustration with the expansion of such evil. However, God IS in control and I think He might just be allowing the weeds to grow so that people’s eyes will be opened to what is REALLY going on....and so that they may see that there are consequences to their choices.
“The problem with that ‘pluripotent’ cell is that it is a human embryo that could be a scientist, or physician, or mathematician, or musician, or philanthropist, or just a regular old good guy........”
I agree. I do not believe that innocent life should be destroyed to create cures for others.
It is a tough argument to make, given that IVF treatment is so common, and that it results in the destruction of thousands of embryos each day. Many protest vigorously the use of these embryos for the creation of stem cells that may provide cures. However, when it comes to the huge number of embryos produced, stored and discarded in the fertility industry they are silent. My belief is that the destruction of embryos is wrong in either circumstance.
I think it would have been very difficult for the Bush FDA to prevent this trial on the basis that it uses ESCs. GWB did not make it illegal to create and use ESCs, he only limited what the federal government would finance. I would think that if GWB wanted to prevent the use of embryos to create stem cell lines, he would have made it illegal. Once he has allowed the destruction of the embryo, what benefit is there to preventing the treatment derived from it?
My problem is with the argument that, since we are doing one thing morally wrong, that it is not a problem to compound it with something else morally wrong.
The "snowflake babies" pictured with President Bush above prove that these are human beings, and not just "tissue" being discarded.
Let's work to change what is wrong. Not pile more wrong on top of it.
I Miss our President. ;(
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