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.
...not necessarily. Federal funding can be used for lines derived prior to 2001.
A better approach than President Bush's might have been to keep up with the science and support the techniques (that were developed later) that don't require fetus destruction. By the Administration being so rigid and dogmatic instead of reality-based, more embryos have been killed in private and overseas research.
This is a big winner issue for Obama. The Bush Administration's mishandling of this issue has alienated a lot of Americans. Many wonder why federal funds couldn't be used for research that doesn't destroy any fetus, yet has the potential of saving lives and alleviating suffering.
Yes they do
All of the embryos are destroyed once the stem cells are harvested.
Why does it actually have to act on that coding before you classify it as human?If genetic coding were sufficient, cancer cells would be human.
Anyone sane and educated realizes that we have progressed best when following multiple lines of research.
E.g., why did we research optical storage, when magnetic showed such promise?
So which organ is good enough? I really want people to consider this.
How about not justifying this as acceptable because it is just a clump of cells and admitting that you are willing to experiment on human life and accept the consequences of your behavior.
When it is justified as acceptable because it is just a clump of cells, it speaks volumes in comparison to other justifications for tragedies in human history.
If a blastocyst is “a human” and not just “human,” why aren’t those cells being injected into someone else “a human,” too?
It's like the protectionist ostriches who seem to think we can (and should) control everyone else. Leftism under a "conservative" nameplate.
So which organ is good enough? I really want people to consider this. How about not justifying this as acceptable because it is just a clump of cells and admitting that you are willing to experiment on human life and accept the consequences of your behavior. When it is justified as acceptable because it is just a clump of cells, it speaks volumes in comparison to other justifications for tragedies in human history.What is the objective test for humanity?
If a blastocyst is a human and not just human, why arent those cells being injected into someone else a human, too?How can they not be a human?
IOW, if the public ever turns against this idea in sufficient numbers, O could blame Congress.
“Many wonder why federal funds couldn’t be used for research that doesn’t destroy any fetus, yet has the potential of saving lives and alleviating suffering.”
I also think some of the frustration is a lack of consistency in this policy. GWB put limitations on stem cell research funding, yet there are many other types of research, such as fertility treatments, that still qualify for federal funding. This research routinely destroys embryos as well.
IVF clinics routinely destroy embryos in large numbers. Thousands a day are simply washed down the drain, or frozen indefinately. Yet, we rarely hear of efforts to change policies and procedures used in the assisted reproduction processes.
Nope. Good guess, though.
That's the way it was in the past...but not now. First of all, as was pointed out, once the initial harvesting, there are no more embryos destroyed, but now, the blastocyst is unharmed.
Klimanskaya I, Chung Y, Becker S, Lu SJ, Lanza R. (2006). "Human embryonic stem cell lines derived from single blastomeres". Nature 444 (7118): 4815. PMID 16929302 doi:10.1038/nature05142
The current attack on embryonic stem cell research is all a sham. It uses problems of the past to fool people into coughing up $, at the cost of compassion for the suffering.
Besides, many, many, many embryos are destroyed anyway (IVF)...it's a shame that no good can come from that loss.
They want to use Maruta and assist clients as the same time. It’s the liberal idea of killing two birds with one stone.
on stem cells?
Acutally, GWB opened up federal funding for stem cell research where funding had not existed before, including embryonic stem cell research.
who is experimenting on embryos?
Is every drop of blood you shed a separate human?