22 replies to this topic

[captainwelch]

In a watershed moment for one of the most contentious areas of science and American politics, the U.S. Food and Drug Administration cleared the way for the first-ever human trial of a medical treatment derived from embryonic stem cells.

Geron Corp., a Menlo Park, Calif., biotechnology company, is expected to announce Friday that it received a green light from the agency to mount a study of its stem-cell treatment for spinal cord injuries in up to 10 patients. The announcement caps more than a decade of advances in the company's labs and comes on the cusp of a widely expected shift in U.S. policy toward support of embryonic stem-cell research after years of official opposition.



http://online.wsj.co...5825709415.html

[longhaul]

That was quick, bye bye bush....................

[topperf]

2 days...

[Ches]

Thats freakin awesome!

[EmHope]

Thanks for the info Captainwelch! ;)
Where do you get your sources?

[chop-02]

I just saw that on the news...They plan on working on the new injured,with in 14 days of the injury..
It is a great start

[andinoah]

That is sooooo great! I knew it would happen one day! Now there is a brighter light for the future!

[StellaLAtella]

Here is an article I copied from the associated press website:


Jan 23, 7:22 AM EST


Spinal cord injury study approved; will be first human trial of embryonic stem cell therapy

By MALCOLM RITTER
AP Science Writer


AP Photo/JULIE JACOBSON




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NEW YORK (AP) -- A U.S. biotech company says it plans to start this summer the world's first study of a treatment based on human embryonic stem cells - a long-awaited project aimed at spinal cord injury.

The company gained federal permission this week to inject eight to 10 patients with cells derived from embryonic cells, said Dr. Thomas Okarma, president and CEO of Geron Corp. of Menlo Park, Calif.

The patients will be paraplegics, who can use their arms but can't walk. They will receive a single injection within two weeks of their injury.

The study is aimed at testing the safety of the procedure, but doctors will also look for signs of improvement like return of sensation or movement in the legs, Okarma said.

Whatever its outcome, the study will mark a new chapter in the contentious history of embryonic stem cell research in the United States - a field where debate spilled out of the laboratory long ago and into national politics.

While some overseas doctors claim to use human embryonic stem cells in their clinics, stem cell experts said they knew of no previous human studies that use such cells.

"It's a milestone and it's a breakthrough for the field" because Geron passed the safety hurdles for getting federal clearance to launch the study, said Ed Baetge, chief scientific officer of Novocell Inc. His company hopes to begin a similar human study for treating diabetes in a few years.

In addition, said spinal cord injury researcher Dr. Wise Young of Rutgers University, "a lot of hope of the spinal cord injury community is riding on this trial."

Embryonic stem cells can develop into any cell of the body, and scientists have long hoped to harness them for creating replacement tissues to treat a variety of diseases. But research has been controversial because embryos must be destroyed to obtain them.

President Barack Obama has promised to relax the Bush administration's restrictions on federal financing for such research. But Obama's ascent to the White House had nothing to do with the U.S. Food and Drug Administration's granting permission for the new study, Okarma said in a telephone interview Thursday.

In fact, the company says, the project involves stem cells that were eligible for federal funding under Bush, although no federal money was used to develop the experimental treatment or to pay for the human study.

Other human cells, called adult stem cells, have been tested before in people to treat heart problems, for example.

In the Geron study, the injections will be made in the spine at the site of damage. The work will be done in four to seven medical centers around the country, Okarma said.

Animal studies suggest that once injected, the cells will mature and repair what is essentially a lack of insulation around damaged nerves, and also pump out substances that nerves need to function and grow.

Apart from assessing safety, investigators will hope to see some signs of improvement in the patient, Okarma said. The idea is "not to make somebody ... get up and dance the next day," he said, but rather to provide some level of ability that can be improved by physical therapy.

Each patient will receive a low dose of anti-rejection drugs for about two months, because after that time the medications shouldn't be needed, Okarma said. The study will follow each patient for at least a year.

Okarma said he can't estimate how much such a therapy would cost if it proves effective, but that "this is not going to be a $500,000 price tag. It will be remarkably affordable ... in the context of the value it provides."

Evan Snyder, a stem cell researcher at the Burnham Institute for Medical Research in La Jolla, Calif., said scientists in the field will focus chiefly on the study's results about safety.

"The one hope that everybody has is that nothing bad happens," he said.

Geron Corp. has spent at least $100 million on human embryonic stem cell research. Founded in 1992, it does not have any therapies on the market.

However, the company is considered the world's leading embryonic stem cell developer thanks to its claims on several key stem cell technologies. Geron helped finance researchers at the University of Wisconsin who first isolated human embryonic stem cells in 1998. The company has retained exclusive rights on several of those cell types.

---

On the Net:

Geron Corp.: http://www.geron.com/

[carole338]

This was on the NBC Today show. I read the article. The funding was under the Bush administration. I am in now way a supporter of Bush and hope the Obama administration moves this along a lot quicker than the former administration. I posted a comment on Newsvine suggesting those with long-term paralysis be also in tests, not that Newsvine is the place to air our concerns

[captainwelch]

EmHope, on Jan 23 2009, 02:32 PM, said:

Thanks for the info Captainwelch! ;)
Where do you get your sources?

I am obsessed with stem cell research, because I have a spinal cord injury and I study neurobiology. I search all the major news sources for info everyday.

[russ1]

So who would sign up for the trials? Or who would be waiting to see how it went with the first few years. I'd be worried that the 'improvements' would be sensory and would just lead to a lot of pain and not much mobility increase. A full recovory would be awesome - walking a few steps with crutches while in increased pain would be worse that where I am now. I'll be waiting to see how it goes.

[Kev-O]

longhaul, on Jan 23 2009, 04:11 AM, said:

That was quick, bye bye bush....................

Bush or Obama had nothing to do with this

[topperf]

Kev - you are so naive that I can only love you - come to daddy, you need a biiig huuuug

[Kev-O]

topperf, on Jan 24 2009, 03:05 PM, said:

Kev - you are so naive that I can only love you - come to daddy, you need a biiig huuuug

This is a quote from the artical "President Barack Obama has promised to relax the Bush administration's restrictions on federal financing for such research. But Obama's ascent to the White House had nothing to do with the U.S. Food and Drug Administration's granting permission for the new study, Okarma said in a telephone interview Thursday."
The stem cells they are using were the same ones the Bush Administration had.

[quadc5]

russ1, on Jan 24 2009, 01:23 PM, said:

So who would sign up for the trials? Or who would be waiting to see how it went with the first few years. I'd be worried that the 'improvements' would be sensory and would just lead to a lot of pain and not much mobility increase. A full recovory would be awesome - walking a few steps with crutches while in increased pain would be worse that where I am now. I'll be waiting to see how it goes.

If i could get in this study i would. I already have ability to stand with minimal assistance. I can walk in pool and some steps outside of pool. But the pain like you are worried about sucks because i have terrible nerve pain in legs. You take the good with the bad though.

[JT80]

russ1, on Jan 24 2009, 07:23 PM, said:

So who would sign up for the trials? Or who would be waiting to see how it went with the first few years. I'd be worried that the 'improvements' would be sensory and would just lead to a lot of pain and not much mobility increase. A full recovory would be awesome - walking a few steps with crutches while in increased pain would be worse that where I am now. I'll be waiting to see how it goes.

i'm not sure i'd be first in line to be honest - injecting anything into the cord has got to carry a risk of some sort. i vote that those with lower injuries give it a go and report back...thanks.

[topperf]

@Kev - ok. Try and think about this:

"Geron denies that the FDA approval had anything to do with the new administration. However, I would not expect them to gloat over the coincidence. Personally, it is difficult for me to not think there is a connection given the extensive evidence of interference in government agencies during Bush's two terms. At this juncture, it is irrelevant and Geron probably reasons that accusations are not worth the distraction.

However, once safety is determined for any ESC trial, well, it's a whole new world. The Genie will be out of the bottle. Bush and those directing his policy decisions knew that. Hence, no traction on ESC during his time in office."

from "John" at CareCure - I couldn't have put it more precise.

[Kev-O]

topperf, on Jan 25 2009, 08:04 AM, said:

@Kev - ok. Try and think about this:

"Geron denies that the FDA approval had anything to do with the new administration. However, I would not expect them to gloat over the coincidence. Personally, it is difficult for me to not think there is a connection given the extensive evidence of interference in government agencies during Bush's two terms. At this juncture, it is irrelevant and Geron probably reasons that accusations are not worth the distraction.

However, once safety is determined for any ESC trial, well, it's a whole new world. The Genie will be out of the bottle. Bush and those directing his policy decisions knew that. Hence, no traction on ESC during his time in office."

from "John" at CareCure - I couldn't have put it more precise.

Man there's no talking to you all

[kdenon01]

Kev, you tried. But it's a battle you will not win.

[topperf]

@Kdenon01 - for once you're absolutely right, it seems ignorance, or the last 8 years of utterly failed american policy is finally brought to an end.

[Kev-O]

topperf, on Jan 25 2009, 02:48 PM, said:

@Kdenon01 - for once you're absolutely right, it seems ignorance, or the last 8 years of utterly failed american policy is finally brought to an end.

I dont think Americas has failed for the last 8 years.

[kdenon01]

Oh...for ONCE I'm right....

okay...

[edlee]

Topper,,,,, as much as I hate to,,, I have to agree with Kev on this,,,, no matter what "John" infers,,,,, the truth is that the election had nothing whatever to do with this particular study.

When one comes up using formerly banned cell lines,, then politics may play a part,,,,,, but,,, sorry,,, not this time.




As for taking the shots,,,,, sign me up,,,,,I'm already hurting,,, and I'm in my 60s,,, so no great loss either way,, right,,,, might as well try it out on us old coots first.
ed