FDA approves first human embryonic stem cell safety trial (3 days after Pres. Bush left)

Scientific American ^ | 1-23-09 | Jordan Lite

[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.’”

[jveritas]

We will miss even more as time goes on. We have seen nothing yet.

[DeepThought42]

My greatest disappointment when the Republicans held Congress is that they didn’t make it illegal to destroy the human embryos that are stored by fertility clinics. I have never understood why they didn’t take that step.

[SunkenCiv]

Doctor Mengele ping.

[gondramB]

>>So far, ALL EMBRYONIC Tests have caused 1 thing 100% of the time... CANCER!! <<

Searching... I can’t find any previous examples of human trials at all.

[DoingTheFrenchMistake]

Do people think because an American president declares war against science that research around the world ceases on a decree from George Bush. Science like everything else simply moves offshore out of the reach of American Luddites.

Allowing religious based politics to dictate scientific research is akin to witchdoctors deciding what experiments will be conducted at the CERN Lab.

America is losing it’s scientific edge, just look at how the Japanese have mastered space technology I wouldn’t be surprised that they become the new leaders as NASA’s financial mistakes mire it in catching up.

Please in regards to scientific research, lead, follow or get out of the way.

[Gene Eric]

embryonic experimentation ping

[ohioWfan]

The President's ban on the funding of embryonic stem cells is what has led scientists to look for other means of developing stem cells..........umbilical, adult, etc........and find great success.

That will all change under Obama, and this unfunded research, which hasn't been successful, will now get funding, and more unborn children will die.

Who said it upthread? Elections have consequences.

This is a bad one.

[ohioWfan]

1. President Bush never "declared war against science." He denied funding to experimenting on human beings.

2. This is not "religious based politics." It is what is moral and what is right. Being pro-life is not just for the religious. It's for anyone who has a fundamental respect for human life.

3. Not funding the destruction of babies hasn't caused America to lose its edge.

It appears that you have gotten ahold of some propaganda that has led you down a path of lies. Adult stem cell research has flourished since President Bush courageously stood on the side of life.

We owe him a debt of gratitude, not more mindless attacks.

[Gene Eric]

They will farm human life in its earliest form to be used as ingredients for what they call ‘medicine’. In my opinion, this is depraved and twisted.

[STARWISE]

Please in regards to scientific research, do not mutilate or destroy human life.

President George W. Bush holds 14-month-old Trey Jones of Cypress, Texas, following his remarks about stem cell research policy legislation in the East Room of the White House Wednesday, July 19, 2006.

"Each of these children was adopted while still an embryo, and has been blessed with the chance to grow up in a loving family," said the President of children sharing the stage with him.

"These boys and girls are not spare parts. They remind us of what is lost when embryos are destroyed in the name of research." Trey Jones was first introduced to the President during a White House visit in May 2005.

~~~~

I guess if it were up to you, these precious children would be just carved up into frozen parts so they could be "useful" in your world.

God bless and protect the innocent babes.

[Majie Purple]

Yes indeed sad, & I’ll add a very.

[Gene Eric]

>> Please in regards to scientific research, lead, follow or get out of the way.

Science at any cost? Go chow down a few embryos if you think it’s no big deal.

[STARWISE]

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

~~~~~~~

Ditto!

[RobbyS]

Remember how Peggy Noonan used to complain about Georgia Bush, stubborn, uncurious, never willing to change his mind? Obama is an ideologue who hasn’t changed his mind since he was a teeager, and every experience has simply reinfoeced his thinking. Allt his crap abour “pragmatism.” He is like Lenin: an opportunist, who when he gets a change he will simply impose his ideology on all of us.

[STARWISE]

Related

##3

The Facts of When Human Life Begins—Interview With Dr. Maureen Condic (Excellent Reference)

http://www.freerepublic.com/focus/f-news/2177159/posts

[STARWISE]

Re the above:

“Q: You define the moment of conception as the second it takes for the sperm and egg to fuse and form a zygote. What were the scientific principles you used to arrive at this conclusion?

Condic: The central question of “when does human life begin” can be stated in a somewhat different way: When do sperm and egg cease to be, and what kind of thing takes their place once they cease to be?”

[sarah p]

“Please in regards to scientific research, lead, follow or get out of the way.”

Please, follow your own advice and get out of the way.

Your statement that America is losing its scientific edge is just plain wrong. Our country is the destination of choice for scientists from around the world to come for training. Name another country that has produced even 1% of the quality biomedical research as the US.

[STARWISE]

I agree. He’s a frightening soul.

Have you seen this? It’s SO insightful.. watch it.
It’ll give you a tremendous view into the mind
and mental pathology of this strange creature.

http://fora.tv/2008/11/11/Shelby_Steele_On_President-Elect_Obama

[JSteff]

Agreed. The Republicans lost a lot of chances to solidify things while they had the power to do so.

[Humal]

Yes, it is, STARWISE. President Bush brought in scientists and theologians to help him make a decision about using embryonic stem cells. After listening to them for days (I think), he made a sound decision. Obambi over-turned it simply so he wouldn't be like Bush. I'm not a biologist, but from what I've read, embryonic stem cells have not proven effective. OTOH, adult stem cells have proven to work in various cases. I have a friend who will soon be going under back surgery. They will use adult stem cells to help regenerate bone growth in the spine.