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.
If you’re on mars all you need is methane gas as proof of life. Here on earth even a beating baby’s heart doesn’t do it for some
“The baby killers have been set loose!”
YES, they have.... and we need to pray as never before for real conversion of heart for the people of this nation.
Oh, please. Nobody is talking about "carving up" children. How over the top can you get? Embryos are clumps of cells, not babies. And they've already been doing this research, just on lines created before the Bush administration.
Supports federal funding of embryonic stem cell research
Q: Would you expand federal funding of embryonic stem cell research?
A: I believe that we need to fund this. This is a tough issue for those of us in the pro-life community. I would remind you that these stem cells are either going to be discarded or perpetually frozen. We need to do what we can to relieve human suffering. It’s a tough issue. I support federal funding.
Source: 2007 GOP primary debate, at Reagan library, hosted by MSNBC May 3, 2007
***John McCain
http://www.ontheissues.org/Social/John_McCain_Abortion.htm
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.
It's above Obambi's pay grade.
At which point does that clump of cells, that genetically contains everything required to for a new human life, cross the barrier and become protected human life?
I am not denying the need for research and making sure we know what is out there, what is available to us. But the argument you make about embryos being a clump of cells is the same argument pro-choice people make about an abortion... it is just a clump of cells, it isn’t really a human.
So, the ethical argument that President Bush addressed is allowing lines already in existence to get federal funding, but limiting new lines. He did an admirable job in addressing this.
Although, I am all for no federal funding for research. If you let people and companies keep their own money, taxpayer funding wouldn’t be a question for presidents lawmakers to address. Which is exactly what this company did.
And for all of you naysayers out there saying this is something that would not have happened under President Bush, research a bit more. Not in this article that I could quickly find is the fact that the line that this company is using was qualified for federal funding, but the company never sought federal funding for the research or the human trials.
Accoring to the Religion of Obama, this is ok.
2004 Interview: Obama Talks about Jesus, Heaven and Sin
GG: What is sin?OBAMA: Being out of alignment with my values.
GG: What happens if you have sin in your life?
OBAMA: I think its the same thing as the question about heaven. In the same way that if Im true to myself and my faith that that is its own reward, when Im not true to it, its its own punishment.
...
GG: Do you believe in heaven?
OBAMA: Do I believe in the harps and clouds and wings?
GG: A place spiritually you go to after you die?
OBAMA: What I believe in is that if I live my life as well as I can, that I will be rewarded. I dont presume to have knowledge of what happens after I die. But I feel very strongly that whether the reward is in the here and now or in the hereafter, the aligning myself to my faith and my values is a good thing.
When I tuck in my daughters at night and I feel like Ive been a good father to them, and I see in them that I am transferring values that I got from my mother and that theyre kind people and that theyre honest people, and theyre curious people, thats a little piece of heaven.
Obama said that he didn't know when life begins.
Can you be "a little bit pregnant"?
It is life. Barack Obama denies it. He is unwilling to call a baby born alive a baby or LIVE.
He's a monster.
Guys, you need to educate yourselves. The “baby killers” have always been loose in this country. There has never been a ban on research, only a limitation on who and what can receive federal funding.
I couldn't agree more. I have no interest in prolonging my life if the price is the death of innocent people.
I remember being disgusted four years ago when Ballerina Boy Reagan suggested that President Reagan would have supported embryonic stem cell research to improve his condition, NOTHING could have been further from the proof.
Embryonic stem cell research is nothing more than a sham to protect abortion; if there was any promise to it, private companies would be spending billions on research (there has NEVER been a ban on private funds). The reality is that private companies are putting their money in adult and umbilical cord stem cell research and having amazing results.
This argument about a clump of cells has been around such a long time. It was the argument used on people in my generation in the 80s regarding abortion. It isn’t a human, just a clump of cells. It is amazing what 20 years of scientific research regarding ultrasound has accomplished to disprove that argument (3D and 4D ultrasound).
and how many embryos are harmed?
When presented with this meme, just extend the logic: "You're just a clump of cells too, just bigger."
Isn't every living thing a "clump of cells"?
It would be like denying that I was driving a car by saying, "No, I was just holding on to a wheel and pushing some pedals. Is there a law against that?" The argument is disingenuous at best.
Thank you so much for that article and link! Anyone sane has to realize that autochthonous stem cells are the way to go! Of course, those who are propping up embryonic stem cells primarily for ideological (read: pro-abortion) reasons probably won’t be persuaded.
We would be better off researching cybernetics.
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.Does this kill feti?
When presented with this meme, just extend the logic: "You're just a clump of cells too, just bigger."It depends on how the cells are organized into tissues and organs.
At which point does that clump of cells, that genetically contains everything required to for a new human life, cross the barrier and become protected human life?Presumably when it organizes into organs.
Why do you define it there. All of the genetic coding for those organs are in the embryo. Why does it actually have to act on that coding before you classify it as human?
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