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.’”
LOL...as you evade the question.
If you open the refrigerator door today, you are killing a baby...to the same extent that this research is. Did you even read what this research is?
If you take a breath today, you are killing a baby...to the same extent that this research is. Did you even read what this research is?
If you fly to Zanzibar today, you are killing a baby...to the same extent that this research is. Did you even read what this research is?
If you do nothing today, you are killing a baby...to the same extent that this research is. Did you even read what this research is?
To borrow a slogan, this research is killing fewer people than Ted Kennedy's car.
...which is totally irrelevant, since this research
Still, no focus on the nature or source of the “product,” the entire thrust of Pres. Bush’s policy.
Your comments speak of obsession.
I’m sorry if you or a loved one have an illness for which you crave help. I empathize with those whose lives are so affected by their afflictions. We all have afflictions of one sort or another, and God help you and them if you’re obsessively focused on what innocent human baby embryos can provide YOU, blinding you to their God-given right to life. It’s depraved.
Sure you did.
"According to" applies to the entire second clause, FRiend. You're attributing the "God kills" part to "the Catholic definition" by the way you wrote.
Perhaps it was unintentional, but that's the meaning nonetheless.
Those who choose to acknowledge that an embryo is a living human being believe that it does not matter where the life is aborted.So then the people who were killed in the firebombings of Tokyo and Dresden were aborted?
Are you any less murdered if it happens in your kitchen or in a ravine? If another human being is killing you, what difference does the "physical location" make?It does not.
Do you know what they call animals that feed on the flesh of their own species?Is anyone eating stem cells?
Yes, I agree. God allows evil (see the Book of Job) for reasons we can’t comprehend, but in the big picture it will all make sense someday!
Terminology aside, why are you defending the premeditated murder of human beings?
I like how you make baseless insults against people, implying that they wish people harm or accuse them of god knows what else, including that nice lovely post about me.
You attack and slander your opposition when they don’t agree with you. God forbid anyone thinks different than you.
What...where you hoped that treatment of people with spinal cord injuries would fail? How is that not sick?
Just stop. You win. I'm such a horrible person who doesn't care about humanity and the physical suffering of others. I sit back and hope that everyone and anyone with any physical ailment dies. Yes, that's exactly, who, what, how I am. /sarc I'm hoping nothing comes of it for moral reasons. I've stated that several times. And investing in other types of stem cells with a much more positive track record is where my support lies. Please don't respond to me again. I have no time for it. And your insults are pathetic.
That is an AWESOME and inspirational article!! :*)
Thank you for posting it!! I’m going to share it with everyone I know...prayers for Gary Graham for sharing the truth despite the probably shunning he will receive from Hollywood types!
I started reading the comments and was STUNNED (I only got about halfway) to see that ALL the comments to that point were POSITIVE and spoke about the right to life for the pre-born babies. Brought a tear to my eye seeing so many personal stories reiterating what Mr. Graham said in his article.
The source of the “product” was a laboratory, using a line from long ago.
Excuse me, I guess you forgot ... “the nature ?”
You’re acting a fool, playing idiotic word games.
I’m done with you and deeply selfish mentality.
I will join the others in ignoring you, as you are not asking questions out of legitimate concerns, but as an attempt (and failure) to ridicule or trap those who don't share your cynical views.
You obviously carry some weird baggage with you, since you attacked me in your first post, but I seriously don't remember you at all. And now I know why. You're best forgotten.
(btw, you asked me no question, therefore it was impossible to 'evade' it. Not that logic ever enters your thought process).
I trust that you, after some thought, realize that this question makes no sense whatsoever, and does not relate to the point I was making.
Abortion is the process of destroying a human life before it is born.
My point still stands. It is wrong for one human being to end the life of an innocent human being.
The “nature” of it is tissue, similar to organs from a deceased person, this is pre-organ tissue derived from procedures conducted on pre-organ tissue from a blastocyst that is long, long gone.
So are you against organ donation from the deceased, too?
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