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?
“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.
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.)
There are more articles, but this gives you an idea of where my views were coming from.
It was discovered that the existing embryonic lines were contaminated.
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.
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?
(Of course, some folks get it...e.g., Intolerant in NJ at #15 :-)
Because I'm not an ignorant fool, so I realize that my spinal nerves don't have as much potential to help as this, and I also realize that there's no need for anyone to be killed to allow this research to proceed.
Who are we to classify which human lives are ok to sacrifice?
Please tell me, since you seem so intent on sacrificing someone even when there's no need.
There is no need to sacrifice human life when other avenues are not only available, but more productive.
WE HAVE HEARD IT STATED SO OFTEN it has become a media mantra: Embryonic stem cells (ESCs) offer the greatest hope for cures; adult and umbilical cord blood stem cells have far less potential; the Bush administration's embryonic stem cell funding restrictions have caused America to fall behind in the great international race to develop effective ESC treatments.
Baloney, baloney, and pure baloney: The problems with harnessing embryonic stem cells as treatments appear to be growing, not shrinking.
By contrast, the umbilical cord blood and adult stem-cell breakthroughs keep on coming. Human trials are ongoing for heart disease, spinal cord injury, eye afflictions, and many other diseases. And here's a bit of potentially very big news: A just-published peer-reviewed study (Cytotherapy, Vol. 7. No. 4 (2005), 368-373) reports that scientists have used umbilical cord blood stem cells to restore feeling and mobility to a spinal cord injury patient.
UK Researcher: Cord Blood Real Potential for Cures, Not Embryonic Stem Cells -
There is another motive for this move by Obama.Either Eugenics, more abortions, or more ridicule to Bush.
I take it that since you are replying to me, you will not mind me replying to you and pointing out that you're full of ___.
Whether they stick these cells into these peoples' backs or not, there will not be a single difference in the number of embryos destroyed.
I don't believe you are pro-life or compassionate. Based on your repeated ignoring of reality, evidence, and logic, I believe you are pro-disruption and anti-compassion.
But that's simply my conclusion based on your actions. You might be a wonderful person just doing a fine acting job.
I am not intent on anyone being sacrificed. If you have read my posts, you would see that I am for advancement of research that does not depend on the destruction of human life.
Also, how do you know that your spinal nerves don’t have potential to help? Of course I was being sarcastic in asking that.
My point was that there are ethical lines to what type of research should be done. There is no public outcry for research that would require the destruction of already born humans because it is obviously wrong.
If we advance embryonic stem cell research, it is only going to increase the demand for more embryos. There are also many more problems that need to be resolved using embryonic cells with rejection from the patients immune system. This problem does not exist when adult stem cell from the patient are used.
It makes more sense ethically, scientifically and financially to develop adult stem cells instead of embryonic.
Only to the ignorant or dishonest.
But let's hear you explain how this research that is in the article and was proceeding under the Bush Administration was going to result in a single death.
I wasn’t trying to be anti-science at all, I was more concerned with the legalities... with which I was somewhat unclear.
Short point: I’m tired of certain people or groups being treated differently because they happen to line up with some political line. (Why did that guy who had the FBI marked monies in his freezer NOT go to jail? How did he get re-elected? Why did nothing come of the multiple federal investigations of ACORN?)
Some animals are more equal than others. [/cynic]
Oh? Support this claim, please.
How does that in with the research that is the topic of this thread?