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.’”

[Gondring]

You do not understand what an abstract is, evidently.

Read more than the background, and you'll see that they demonstrated the ability to generate a line from a single cell, with the embryo continuing to develop after that. Post-online-publication supplementary information and corrigenda are also provided, but you evidently ignored it.

What I wonder, though, is if you care.

Are you against this research anyway?

[Gondring]

There has been zero therapies with embryonic stem cells that have helped anyone. The results of the therapies have all done nothing to assist the patient’s medical condition [...]

Could that possibly be because there haven't been any human trials yet, because of all the obstacles in the way?

For stuff sitting in glassware, though, there have been successes...such as "Researchers produce blood in the lab from [embryonic] stem cells" (Aug 2008):

Scientists said today that they have devised a way to grow large quantities of blood in the lab using human embryonic stem cells, potentially making blood drives a relic of the past.

But experts cautioned that although it represented a significant technical advance, the new approach required several key improvements before it could be considered a realistic alternative to donor blood.

The research team outlined a four-step process for turning embryonic stem cells into red blood cells capable of carrying as much oxygen as normal blood. The procedure was published online in the journal Blood.

[...]

Researchers have tried to harness the so-called adult stem cells that are responsible for making blood in the body, but their methods were far too inefficient to be put to practical use, experts said.

In the new study, researchers were able to make up to 100 billion red blood cells – enough to fill two or three collection tubes – from a single plate of embryonic stem cells.

Are you one of the ghouls who is disappointed when research that can help save lives is successful?

I do not support taking a bad situation and making it worse.

'scuse me, but

You're the one who wants to take a situation where we have a long-gone embryo...and make it worse by not even using the byproduct of that long-gone embryo to help people. It's taking a bad situation and making it worse, by watching other people die who might potentially be saved by this research...and not a single embryo is being killed by this research going forward.

It blows my mind that you're against this trial proceeding.

I do not support the killing of unborn children on the rhetoric that some day it will do wonders, when there is no proof it has done any good.

Oh, you must have the wrong thread, since that's totally irrelevant to the research in this story.

Stop killing the unborn.

To whom is that addressed?!?

[mjaneangels@aolcom]

I see no reason to continue this discussion with you. You are on record here to be for killing embryos.

[Gondring]

Show me where. I call you on that dishonesty.

[mjaneangels@aolcom]

You have repeatedly indicated you are for embryonic stem cell research. Embryonic stem cell research kills embryos, therefore you must be for it.

All your links regarding the research are pie in the sky...someday, maybe, somehow... and you seem to think they exist today. They don’t. The reality today is the embryonic stem cells are only harvested by killing the embryos. The other reality today is that they have done no good for anyone.

You are the dishonest one who believes the fantasy that may or may not be the future and ignores the reality of today. That is support for killing embryos, whether you want to admit it or not.

[Gondring]

This research will not result in a single embro's destruction. That is here, today, right now.

Are you just trolling, or are you really unable to grasp that concept? Are you being dishonest, or do you really not understand the research being conducted?

Again, for the -nth time, NOT A SINGLE EMBRYO WILL BE DESTROYED FOR THIS RESEARCH.

If you think there is, please explain exactly how you claim that will happen. And if you honestly do not understand what is going on with this research, please re-read the article and ask if you don't understand. I fear that misleading propaganda is giving you a distorted view.

There are millions of embryonic stem cells that have been subcultured (reproduced) from the originally obtained cells. NO embryos need to be destroyed for this research, as the original cells have been subcultured in vitro over several passages ("generations").

So with no deaths--but the potential of saving lives--this is the Pro-Life path. Fighting it is pro-death.

[Gondring]

Here's what happened after the initial cells were harvested more than a decade ago, from NIH website...

Over the course of several days, the cells of the inner cell mass proliferate and begin to crowd the culture dish. When this occurs, they are removed gently and plated into several fresh culture dishes. The process of replating the cells is repeated many times and for many months, and is called subculturing. Each cycle of subculturing the cells is referred to as a passage. After six months or more, the original 30 cells of the inner cell mass yield millions of embryonic stem cells. Embryonic stem cells that have proliferated in cell culture for six or more months without differentiating, are pluripotent, and appear genetically normal are referred to as an embryonic stem cell line.

Once cell lines are established, or even before that stage, batches of them can be frozen and shipped to other laboratories for further culture and experimentation.

[mjaneangels@aolcom]

“This research will not result in a single embro’s destruction. That is here, today, right now.”

Because the embryos they came from HAVE ALREADY BEEN DESTROYED. Did you not read the link you sent me about how they someday hope to not have to destroy embryos. That is because current technology STILL REQUIRES THE DESTRUCTION OF THE EMBRYO TO HARVEST THE STEM CELLS.

Please read YOUR links before sending them to others to defend your indefensible position.

[Gondring]

And when was the last embryo harvested for this research???

MORE THAN A DECADE AGO!

How many more are going to be destroyed for this research?

NONE!

Are you really unable to understand “past tense”...???