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.’”
Are you still into pedophilia?
If you can take some time away from it, you might try a new experience, such as getting acquainted with reality.
Let me clarify, I hope embryonic stem cell research, which harvests massive amounts of cells from the unborn, gets nowhere.
Okay, but how about making comments that are relevant to the research discussed in the article?
Of course there’s potential. Read what I wrote...I specified practicality.
And of course that verbiage I posted was meant to encourage investors.
Post to wrong thread, or did you not check upthread to see what was being discussed? We were discussing definitions. Someone doesn’t get a second chance just because it was natural causes or not. Death is death.
I never said that. I said that by using the Catholic definition of the commencement of life/death, ...
The second half is the independent clause, not tied to the “Catholic” adjective.
It meets his criteria, though they did not actually use Federal funding.
“who is experimenting on embryos?”
The Frankenscientists.
* The derivation process (which begins with the destruction of the embryo) was initiated prior to 9:00 P.M. EDT on August 9, 2001.
* The stem cells must have been derived from an embryo that was created for reproductive purposes and was no longer needed.
* Informed consent must have been obtained for the donation of the embryo and that donation must not have involved financial inducements.”
~~~
From the article:
*will test whether it is safe to inject nerve cells from embryos into the site of their injuries,
*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.
###
Geron’s under no guidelines now as to the source for their embryonic elements, are they?
I was posting on the right thread. It was in response to what seemed like a snide comment that you made. “According to the Catholic definition, God kills off more than half of humans before they are born.” I realize that you posted that in response to an attempt to define when life starts.
I was pointing out that there is a difference between a death of another that is purposefully caused by another human and a death that occurs through natural causes. I am quite sure that Catholics don’t believe that God “kills off” anyone.
You seem to have a habit of trying to play off of words instead of addressing the actual point of peoples’ posts.
You must be a liberal.
You accused me of making something up. You were wrong and it’s obvious that you don’t have the scientific background to back up that accusation.
How much private sector money was invested in this "potential hope?"
Plenty. It availed nothing.
Why is government money more promising than private sector money?
What the heck are you going on about?!?
The research trials are just beginning, and the results to date (using private investment) have been promising...and nobody is asking for public funds.
Where are you getting that idea?
Can't back up your claim of inevitability, I see.
BTW, I had meant to include your words of...
So, it is obvious that an increased demand for embryonic stem cells would result in an increased demand for embryos....which was what I was actually intending to say you couldn't back up.
I still hold to it that the burden of proof is on you to demonstrate that we have an insufficient number of fetuses being destroyed in this country, that we cannot generate additional embryonic stem cells from existing lines, or that it is inevitable over a practical timeline that all lines will be contaminated, despite rigorous QA/QC protocol, including splitting, etc.
Some say, "Put up or shut up." I'll just say that I'm waiting for you to back up your ridiculously unsupported--and unsupportable--claim.
BTW, your conclusion that I'm a liberal is based upon incorrect premises. It seems your reasoning is likely sound.
And considering my conservative activism was featured in a NY Times bestseller by a conservative author, I think you can't just do proof by assertion or appeal to authority.
You accused me of making something up. You were wrong and it’s obvious that you don’t have the scientific background to back up that accusation.
I get paid nicely for application of my scientific background, both education and experience. What you're missing is, again, that your premises are incorrect.
My scientific background is strong enough to recognize that you're trying to weasel out of the burden of proof that's on you for making your initial assertions that contamination is inevitable and requiring additional fetuses is inevitable. I'm not going to be red herring'd into forgetting you're on the hot seat. :-)
I think the Bible is quite clear that He creates those people (and by Catholic beliefs, gives each one a poor soul) that don't even have the opportunity to see more than a few days on this temporal plane (though [depending on belief] they might likely be the lucky ones, if they go to heaven sooner than those who have the delay of up to a century or more...). Does something or someone kill them off or does He let it happen?
Frankly--though it might be quite distasteful to consider--if you're going to say that God just "lets the embryos die" and doesn't kill them, then He's rather like an abortionist who lets a baby sit there to die...no? Personally, I can't picture a loving God like that.
Sorry.. I was going outside of the scope of this article.
What a sick post.
What claim are you asking me to back up? I stated “So, it is obvious that an increased demand for embryonic stem cells would result in an increased demand for embryos.”
Are you actually proposing that the cell lines that they have now are somehow going to last forever and that an increased demand for cells will never lead to the need for the production of more lines to be created?
You are jumping to your own conclusions about what I wrote. I never stated that “it is inevitable over a practical timeline...” Those are your words. What do you define as a practical timeline? I never put any time limit on my claim that inevitably more embryos would be required.
You also wrote that you are “waiting for (me) to back up (my) ridiculously unsupported—and unsupportable—claim.”
If you believe that my claim is unsupportable, then why are you waiting for me to back it up?
Also, I don’t know why you are holding the burden of proof on me “to demonstrate that we have an insufficient number of fetuses being destroyed in this country.” I don’t think that any fetuses should be destroyed. I also believe that far too many “extra” embryos are being made in the first place.
Finally, I don’t know who you are and I really don’t care how much money that you make. You appear to be playing games and deliberately misconstruing my statements. Your attempts to intimate me, for whatever reason, are not working.
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.
Your Posts are Excellent, Ohio! You have a Gift from Heaven, and Always Set Forth the Truth So Well. God Bless you, Dear Friend!
Very much so.
But an insight into the anger, mindless insults, condescension, arrogance, attempts at intimidation and lack of rational thought in all previous posts, IMO.
"The fear of God is the beginning of wisdom."
Thank you, Kitty Mittens! You have such a gift of encouragement!
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.