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.’”
“Injecting these stem cells into these people with spinal cord injuries is not resulting in the destruction of any embryos.”
Getting the embrionic stem cells to inject into others requires the destruction of the embryos. The injections happen after the embryo is destroyed.
“This makes it sounds like they are taking cells directly from fetuses instead of limited lines grown in the lab”
The lines grown in a lab come from fetuses.
Injecting these stem cells into these people with spinal cord injuries is not resulting in the destruction of any embryos.
I suppose that using the organs from someone who is already dead is also a problem for you, eh? Better to just let them rot?
“Injecting these stem cells into these people with spinal cord injuries is not resulting in the destruction of any embryos.”
The stem cells come from embryos that have been destroyed. There is no other way to get them.
You cannot inject embryonic stem cells until you have them to inject. That requires destruction of embryos.
“There’s a difference between using organs from someone who has given his informed consent before he died and selecting someone because he has a kidney you need and killing him for it.”
Thank you.
See my reply 306, if you are interested.
I know someone who had embryonic stem cells implanted in her retina back in the late 1990’s. She worked at the University of Chicago Hospitals as a volunteer. I don’t know whether it worked. She never was without those special glasses with the special cutting on the lenses. I don’t think she was around there much longer after the surgery.
What about someone who did not give consent, but is already dead? Just curious (since that's a closer analogy to what we have here).
Not true, as has been pointed out a few times on the thread.
You cannot inject embryonic stem cells until you have them to inject. That requires destruction of embryos.
American liberty required the sacrifice of patriots' lives. Are you saying that by exercising liberties today, we are killing patriots?
No embryos or blastocyst will be killed by this research; this line was generated more than a decade ago. Are you saying that this potential help for mankind should be discarded, rather than potentially saving lives? Using it does not take any lives, but may save lives. That seems to be the pro-life approach. Discarding it wouldn't take any lives, and wouldn't help save any lives. That doesn't seem to be the pro-life choice...it seems to be the agenda-driven, anti-humanity path.
The law recognizes the right of parents to give consent for donation of a child’s organs. Parents were consulted regarding these embryos.
“Not true, as has been pointed out a few times on the thread.”
Do not confuse embryonic stem cells that only come from destroyed embryos with adult stem cells that do not destroy any live being.
This thread is on embryonic stem cells. They do require the destruction of embryos to harvest the stem cells.
“No embryos or blastocyst will be killed by this research; this line was generated more than a decade ago.”
The embryos were already destroyed, that is the reason they will not be killed. They already have been killed.
Your question about liberties ignores that others, who have not had any say have and will be killed. Do you think it is OK to randomly kill someone because someone else believes it may help them, even though there is no science proving that?
Patriots protect the innocent, they do not follow random killing sprees in hopes that something good might come from it.
okay, have it your way. Flush the cells down the toilet. You can probably find one of your friendly neighborhood abortion clinics to do it for you...they should be able to help you with the task.
As for me, I’d like to see them go to some good use, promoting life and relieving distress.
Exactly right.
The sanctimonious crowd likes to ignore the reality.
One more thing. There has been zero therapies with embryonic stem cells that have helped anyone. The results of the therapies have all done nothing to assist the patient’s medical condition and, sometimes, have created tumors. I do not support taking a bad situation and making it worse. I do not support the killing of unborn children on the rhetoric that some day it will do wonders, when there is no proof it has done any good.
Stop killing the unborn.
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