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FDA approves first human embryonic stem cell safety trial (3 days after Pres. Bush left)
Scientific American ^ | 1-23-09 | Jordan Lite

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.’”


TOPICS: Breaking News; Constitution/Conservatism; Front Page News; Government; Politics/Elections
KEYWORDS: abortion; abovemypaygrade; ameirca2point0; bho44; bhoabortion; bhoethics; cloning; cultureofdeath; culturewar; deathindustry; embryonicstemcells; embryos; fda; firsthundreddays; geneticcannibalism; ghouls; graverobbers; infanticide; junkscience; notbreakingnews; obama; obamatruthfile; prolife; pseudoscience; slaughter; suckers
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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.

~~~~

God help us. We were blessed with a staunch protector of innocent human life ... life is a commodity now. God bless you, Pres. George Bush. Pray for America.

1 posted on 02/02/2009 7:07:23 PM PST by STARWISE
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To: nickcarraway; sandyeggo; Lady In Blue; fatima; NYer; ELS; Salvation; elcid1970; RobbyS; ...

~~Sad ping!


2 posted on 02/02/2009 7:09:46 PM PST by STARWISE ( They (LIBS-STILL) think of this WOT as Bush's war, not America's war- Richard Miniter))
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To: STARWISE

I hope this falls flat on its ass. The Embryonic Stem Cell Research gets us nowhere.


3 posted on 02/02/2009 7:11:16 PM PST by benjibrowder (Looking forward to kicking Obama out of office in 2012.)
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To: STARWISE

Very sad indeed. I do not think we will ever get a moral President as President Bush was. He believed in life and fought to preserve it and to protect it on all fronts.


4 posted on 02/02/2009 7:12:56 PM PST by jveritas (God Bless our brave troops)
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To: STARWISE

The baby killers have been set loose!


5 posted on 02/02/2009 7:13:19 PM PST by FlingWingFlyer (I wish it was 20 January 2013. I've had enough of this crap already.)
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To: STARWISE

Where is the photo of the wilting flowers? This is sad beyond belief.


6 posted on 02/02/2009 7:13:19 PM PST by littlehouse36
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To: STARWISE

This makes it sounds like they are taking cells directly from fetuses instead of limited lines grown in the lab - quite a change if that is really what they are doing.


7 posted on 02/02/2009 7:14:55 PM PST by gondramB (Preach the Gospel at all times, and when necessary, use words.)
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To: FlingWingFlyer

Why is anyone surprised? ELECTIONS HAVE CONSEQUENCES.


8 posted on 02/02/2009 7:15:15 PM PST by Hildy
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To: STARWISE

“~~Sad ping!”

Very sad. Experimenting on human embryos, reversing the Mexico City Policy so tax dollars are paid for abortions in other countries, etc..

Evil is spreading like wildfire.


9 posted on 02/02/2009 7:17:11 PM PST by Sun (Pray that God sends us good leaders. Please say a prayer now.)
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To: jveritas
“He believed in life”

Even more he was intelligent. He realized science was showing NON embryonic cells have more promise.

10 posted on 02/02/2009 7:18:04 PM PST by JSteff (It was ALL about SCOTUS. Most forget about that and may have doomed us for a generation or more.)
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To: JSteff

Agree 100%.


11 posted on 02/02/2009 7:20:57 PM PST by jveritas (God Bless our brave troops)
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To: Hildy
Hopefully many of the dummies are now seeing this. But many more dummies are too busy to care.

Their apathy towards getting the real story is part of what will doom us for several years.

12 posted on 02/02/2009 7:21:11 PM PST by JSteff (It was ALL about SCOTUS. Most forget about that and may have doomed us for a generation or more.)
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To: gondramB

“instead of limited lines grown in the lab”

In this case most likely contaminated lines. They have been for years. One of the many reasons that this type of research FAILS.


13 posted on 02/02/2009 7:21:37 PM PST by swmobuffalo ("We didn't seek the approval of Code Pink and MoveOn.org before deciding what to do")
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To: STARWISE

“I like the idea of the American people’s representatives expressing their views on an issue like this.” -BO

Roe v. Wade didn’t allow the American people to express their views on an issue like this.


14 posted on 02/02/2009 7:21:39 PM PST by madameguinot (Our Father's God to Thee, Author of Liberty)
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To: STARWISE
FDA approves first human embryonic stem cell safety trial (3 days after Pres. Bush left)...yeah, Mike Huckman reported the story this way on CNBC when it first came out last week - as though suddenly the clouds had parted, all the light of heaven had descended on earth, and science was saved because Obama was now president - no mention of the fact that study would have had to have been in progress for years - meaning it was undertaken with every anticipation that it could be effectively completed - mid-Bush administration - one has to marvel at the ingenuity of the loony left in finding ways to spin any story toward their orthodoxy......
15 posted on 02/02/2009 7:22:47 PM PST by Intolerant in NJ
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To: STARWISE
"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.”

Translation: "We have all these dead babies. There must be something we can do with them."

Why read Mary Shelley's Frankenstein when you can pick up a newspaper?

16 posted on 02/02/2009 7:23:46 PM PST by SamuraiScot
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To: STARWISE; xzins; wagglebee; wmfights

I for one would rather DIE than use an embryonic stem cell to prolong my life.


17 posted on 02/02/2009 7:24:58 PM PST by P-Marlowe (LPFOKETT GAHCOEEP-w/o*)
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To: benjibrowder
This makes me think of the reason d'etre of "I am Legend" - the "cure" that turns into a plague that basically kills everyone. Or worse.

We've brought it on ourselves...

18 posted on 02/02/2009 7:27:20 PM PST by Starfleet Command
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To: STARWISE

If they are ready for human trials now, they were doing the research during the entire Bush administration...they just were doing it without federal funding.


19 posted on 02/02/2009 7:27:55 PM PST by Amelia
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To: STARWISE
And people continue to claim that having a pro-life President doesn't make any difference.....

Pray for America!

20 posted on 02/02/2009 7:29:45 PM PST by ohioWfan (Thank you PRESIDENT BUSH!!!)
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