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.’”
I respect your perspective, and agree with your sentiment to a degree. But if you recall, President Bush's decision was certainly not something most conservatives greeted with joy, so why wouldn't there be concerns here, whatever the misleading subtitle?
In fact, wouldn't one be a hypocrite NOT to object to this now if one was bugged by it under Bush?
I am of the belief that this kind of thing is a slippery slope issue.
Thanks for opening up this discussion beyond the "You're prochoice!" screaming that sometimes is thrown about here when someone actually engages in discussion about the value of this kind of research.
“Does this mean that they deserve legal protections?”
Well, I figured that someone would ask that.
No, of course these cells do not require legal protection! There is a huge difference here. Cancer cells are living human cells, not a living human organism. Cancer cells are diseased and threaten the life of the human that they are in. This is similar to a person getting a bacterial infection in their body, such as gangrene, and having parts amputated. Killing cancer cells and infected cells is not the same as killing the entire human. Removing these cells is done to protect the life of a human, not to destroy it.
When an embryo is “harvested” for stem cells it kills the embryo. Certainly you can understand the difference here.
There are thousands of embryos in storage, left over from in-vitro fertilization attempts. Some have been "abandoned" by their parents, who no longer pay the storage fees required by the labs, and who don't want any other children, but don't want to give the embryos away to other couples or destroy them, either. Many of these couples would be willing to give the embryos to research, however (at least according to polls of the couples).
That's what I mean about opening the door.
Basically, the END does NOT justify the means. It is neither good ethics nor good science.....as leading scientists are coming to see:
“Wisconsin stem cell researcher James Thomson (dubbed the Father of Embryonic Stem-Cell research) has shifted his focus:
“I personally believe that the future is in the (adult skin) cells,” said Thomson, speaking during a press conference on Tuesday [in September].
Thompson’s not the only ‘father of embryonic stem cell research’ to hold this view of induced pluripotent stem cells. Others include:
Sir Martin Evans : “This will be the long-term solution.”
(Dr. Evans is the man who 1st isloated embryonic stem cells in 1981 and winner of this year’s Nobel Prize in Medicine)
Dr. Ian Wilmut: “”this is the future of stem cell research: and it’s “100 times more interesting.”
(Dr. Wilmut cloned Dolly, now has given up on SCNT because he “believes a rival method pioneered in Japan has better potential for making human embryonic cells which can be used to grow a patient’s own cells and
tissues for a vast range of treatments.)
Dr. John Gearhart “I think this is the future of stem cell research,”
(the biologist who first discovered human fetal embryonic stem cells).
Dr. James Thompson: “A decade from now, this [hES controversy] will be just a funny historical footnote,” “Isn’t it great to start a field and then to end it?”
(1st to grow human embryonic stem cell lines in 1998 AND who reprogrammed skin to ‘embryonic’ in the US).”
Ultimately, science confirms the truth of moral solutions.
It would have happened no matter who was president.
I'm saddened that FR has become proudly anti-science and proudly knee-jerk, it seems. It truly hurts our cause to display such irrationality. I hope that some people will stop and think and get informed instead of just screaming.
Sometimes some of us act much more like emotional liberals than like rational conservatives...
It is naive to think that these cells are just going to be taken from these freezers and injected into some patient for some miracle cure. These embryos could be used for the very early stages of research, but this is only the first step.
For embryonic stem cells to have a chance at resulting in a successful clinical applications in the future, it is likely that they would have to undergo genetic manipulation. In other words, cloning of human cells. That is a path that should be avoided for obvious ethical reasons.
The existence of so many frozen embryos is a whole other issue. The production of “extra” embryos needs to be limited, not exploited.
The rest of your post deserves to be ignored, as it makes no sense in the real world.
I meant that my proposed definition of the beginning of human life doesn't correspond to the Catholic one.
Excerpt:
The Food and Drug Administration has approved the use of embryonic stem cells in human trials for the first time.
While the trials involve controversial embryonic cells that have problems with tumors and immune system rejection, the use of adult stem cells has already proven safe for spinal cord patients.
Despite grave concerns that problems such as the causing of tumors and immune system rejection issues haven't been solved, the FDA approved the trials last week.
It gave Geron Corp., based in California, permission to conduct the first-ever human trial for a treatment derived from the controversial cells. The trials will involve 10 spinal cord patients.
However, the safety of adult stem cell transplants in spinal cord injury patients has already been proved in two clinical trials involving studies in Australia and Portugal.
The Australian research group reported its findings in the August 2008 edition of the medical journal Brain, saying that “transplantation of autologous olfactory ensheathing cells into the injured spinal cord is feasible and is safe up to one year post-implantation.”
In Portugal, a group headed by Carlos Lima also used autologous olfactory stem cell transplants and put them into the spinal lesions of paraplegic and tetraplegic patients.
In a July 2006 Journal of Spinal Cord Medicine article, they wrote that adult stem cells are beginning to offer the most hope for those paralyzed from spinal cord injuries.
Lima's team's adult stem cell research showed restored motor function and sensation in a few paralyzed patients using adult stem cells obtained from a patient's own nose.
Just curious.
As to the second part of your comment....
If you do not believe a human being is alive, then you, obviously will not call their destruction a death.
I do. (See above photos of these very obviously human babies).
But if you are wrong and I am right, millions of human beings have died.
If I am wrong and you are right, no harm has been done.
The wrongness of creating human beings that will be discarded doesn't justify the wrongness of using those human beings for research.
Embryonic stem cell research is wrong.
When an embryo is “harvested” for stem cells it kills the embryo. Certainly you can understand the difference here.Embryos do have an organ and tissue structure, one of the necessary conditions of being "a" human as opposed to human.
"Geron (who will now get our taxpayer millions/billions) 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."
In other reports on this, the cell lines used by this company qualified for federal funding under President Bush’s guidelines, but the company never pursued funding.
So, yeah, I believe this can be “coincidental.” The FDA approval process takes years; this didn’t suddenly happen in the last few days.
** ... it was a coincidence that the announcement came just three days after George Bush left the White House.**
That’s a HOOT. ONly a LIBERAL would be SO STUPID as to think we’re gonna fall for a “COINCIDENCE!” Let’s see .. Bush leaves office on 1/20 .. Embryonic stem cell tests 1/23...
US Government works THAT FAST ... LOLOLOLOL ... hahahahahahaha
Starwise.. thanks for the jumping off point for these liberal scum.
“These studies indicate that adult stem cells show far more promise than embryonic cells to treat diseases.”
This isn’t true. There has been far more research done on multipotent stem cells, so there are more current therapies, and more that will probably be useable in the near future. The use of pluripotent cells is more complicated, and there are some difficult challenges faced. That doesn’t mean that there isn’t promise or potential in the treatments, only that their use is further off in the future.
Raise your hand if you have an illness or condition that you would like baby parts to help cure you. Who is more important than whom? Who wants to play G-d? Let’s not always see the same hands!
Idiocy alert!! The same FDA that was so inept in the peanut butter fiasco....
I don’t think that it is a coincidence that the media chose to release this story just 3 days after Bush left office. It seems like another propaganda tactic to make it seem like Obama had something to do with it.
This research must have been going on for years (when Bush was in office) to get to the point it is at now.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.