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.’”
“The maruta must be conserved!”
-Dr Shiro Ishi,
commander of Unit 731
Obviously, I am referring to how research could be conducted, not how it is currently done. It’s easier to go offshore than to stop killing embryos, with the way the current restrictions are.
Wasn't this what adult stem cell research did? They did have a number of embryonic cells that they were using. If I remember correctly, and without looking it up, I believe President Bush's plan said no additional embryonic cells could be developed than what was already had. They could use existing cells, and they did not prove to be as effective as adult stem cells.
I remember that he called in scientists, who gave their view on adult stem cell research vs. embryonic stem cell research. Then, he called in clergy (can't remember if he went outside the Christian faith), and they gave their opinion on the morality issue of when life begins and using embryonic stem cells.
See
http://www.frc.org/get.cfm?i=IS06H01
http://www.frc.org/get.cfm?i=IS07L01
http://www.frc.org/insight/adult-stem-cell-sucess-stories-2008-jan-june
http://www.freerepublic.com/focus/f-news/2176333/posts (Can't access the original source. This may be what they are going to do in my friend who is scheduled for back surgery.)
http://www.sciencedaily.com/releases/2009/01/090128160933.htm
There are more articles, but this gives you an idea of where my views were coming from.
</sarc>
It was discovered that the existing embryonic lines were contaminated.
LOL!
Yes, potential hope for spinal cord injury victims always brings me down.
I am all for the use of techniques that do not result in the destruction of the embryo. However, if this is the study that I am thinking of, the embryos were actually destroyed in this research, even though the method of extraction was not the cause of this destruction.
I wasn’t clear whether this was just an initial requirement, until the research reached a certain point, or whether the embryos were destroyed because they did not have an alternative for preserving them.
I was very excited about this research, because I don’t believe those who claim that there are no benefits to be derived from pluripotent stem cells. I believe they have tremendous potential for all kinds of cures, but there is much research to be done.
It is my great hope that pluripotent stem cell lines can one day be extracted from embryos without damaging the embryo in any way. I think we are several years away from such a possibility, but scientists should be working hard towards this possibility.
No.
Do you likewise cheer for more people to get paralyzed, you wonderfully compassionate slug?
Technically you are right, but there hadn’t been requests for embryonic stem cell research funding prior to GWB’s administration.
He did allow the funding, but limited the reseach to existing lines, which proved infeasible due to extensive contamination of the lines created.
One standard I like is to use the medical profession's own definitions. That way, it's pretty hard for them to deny.
What's the medical definition of death? Something like: no heartbeat and/or lack of measurable brain activity? Well then the inverse could certainly define life: Measurable brain activity and a heartbeat.
I understand that this doesn't match the Catholic view, but it would certainly be a significant improvement if the legal definition of a protected human life was the presence of a heartbeat and measurable brain activity.
(That also handily defeats the "fetus is just another organ" idiocy. Does an organ have its own brain and heart?)
“It depends on how the cells are organized into tissues and organs.”
No, it doesn’t depend on how the cells are organized. These “clumps of cells” and even single fertilized egg cells fit all of the scientific parameters required to classify something as alive.
If these cells are not alive, and they certainly are not dead, what are they?
Even single-celled organisms, such as bacteria, are alive, and they never organize into tissues and organisms. How can one argue that bacteria are alive, but human embryonic cells are not.
Some are trying to classify these cells as something other than living to suit their own social agendas.
yes, on stem cells. Scientist have been doing research with embryonic stem cells using animal models, such as rats, for awhile. Using animal cells to study human diseases is the precursor to most human cell research. These studies indicate that adult stem cells show far more promise than embryonic cells to treat diseases.
There is also the larger ethical question of advancing any research that could lead to the large scale dependence on the destruction of human life. The ethical and more practical course should be to provide more funding for adult stem cell research.
Thanks for the reminder of one of the reasons why I stopped posting here, Gondring. (Or is that John Edwards out there......if only John Kerry had been elected, think of all the paralyzed folks who would now be walking....sobbing here.....)
Seriously........liberalism under the guise of "compassion" is still liberalism.
Ending human life for the purpose of research when other methods are available and more productive is the opposite of compassion.
If that's your position, then you are the polar opposite of compassionate, and therefore unable to determine that quality in others.
It is the pro-life movement that cares about not only the unborn, but the mothers, the negative effect that ending their lives has on the culture, and therefore the country. It is we who care, not our foes.
Believing that ending life when other options are not only available, but more productive, is not only liberal, but it is senseless.
Embryonic stem cell research is senseless.
There were requests for funding. And limitations on funding through congress, etc.
“If genetic coding were sufficient, cancer cells would be human.”
If they come from a human, cancer cells ARE both human and living.
As a result, it has been discovered that adult stem cells are more productive, and there is no need to end one human life to save another. I am correct. The President's ban on funding indeed led to expansion on alternatives.
So, of course, yes, it's about funding. But denying funding to death has led to enormous success in other areas of research.
The ethical answer in medicine will always be the most successful in the long run. The ethical answer is to err on the side of life.
“Yes, potential hope for spinal cord injury victims always brings me down.”
Why don’t you give them hope and donate some of your own spinal nerves? Or why don’t we remove them from criminals in prison? Or how about from poor people that are a “burden” on society?
Who are we to classify which human lives are ok to sacrifice?
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