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FDA OKs Embryonic Stem Cell Trials for Humans

1 year ago
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For the first time, human subjects will be used to test a treatment of spinal cord injuries derived from embryonic stem cells, under rules approved by the Food and Drug Administration.

The biopharmaceutical company Geron announced in a news release Friday that the FDA had lifted a hold on the clinical trial using human stem cells, The New York Times reported.

The hold was put into place shortly after the FDA initially cleared the research in January 2009. Regulators became concerned when cysts were discovered in some mice injected with the stem cells. Geron had to run another study on mice and come up with better ways to check the purity of its cells, the Times said.

Researchers believe embryonic stem cells have great promise in medicine because they're so resilient and malleable. Embryonic stem cells can turn into any type of cell in the body, which may mean they can someday be used to create replacements for injured or diseased tissues.

The cells have been controversial because creating them has required the destruction of human embryos, although researchers say they now avoid that practice, the Times said.

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basketx

Yet, please take note, adult stem cells have helped cure injuries/diseases although the technology to obtain them has only been here for a few years; while embryonic stem cells have been in active research both here and abroad for decades during which they have been shown likely to provoke potentially dangerous - even life-threatening - cysts, tumors, and immune reactions in the body, and have never demonstrated the power to cure one thing. Yet,

The trial will enroll no more than 12 patients, with injury to the thoracic region high in the spinal cord, and it is not designed to test whether the treatments actually are effective in restoring any of the patients to normal function. Millions of dollars of grants are available to support this work, which it was indicated earlier has proceeded in accordance with President Bush's long-standing authorization for stem cell research that uses cells derived from those available already, without killing any more embryonic babies. No claims are seen that this research could not have been done with the safe procedure using autologous adult stem cells. Yet, it is fashionable to be in the embryonic stem cell arena.

Quoting from TIME Magazine with CNN, on time.com,
'Cautious Optimism for the First Stem-Cell Human Trial'
By Alice Park Saturday, Jan. 24, 2009.
'"I think it's incredibly exciting," says Dr. Susan Fisher, a stem-cell scientist and a professor of obstetrics, gynecology and reproductive science at University of California, San Francisco. "... It really proves the principle that these sorts of human embryonic-stem-cell therapies can survive the FDA approval process."
'The researchers will be looking for whether the cells cause tumors, trigger an immune response, or start to migrate away from the spinal-cord area. "There are certainly unknowns that we can't predict," says Dr. David Scadden, co-director of the Harvard Stem Cell Institute. "We don't know whether or not these cells might grow abnormally in a person. We don't know if things might occur just by these cells being present that could result in an outcome we don't want. This really is a first go, with a lot on the line."' [A lot on the line for the patient, and all lost for the young life of the embryo. -Ed.]

'Dr. Ronald Crystal, chairman of the department of genetic medicine at New York–Presbyterian Hospital/Weill Cornell Medical College, knows those stakes all too well. He is a veteran of the last revolution in medical technology, gene therapy, which, after some hyped expectations in the 1990s, fell into disfavor after some unsuccessful trials. Crystal is cautiously optimistic about the potential for this trial to open the door to future stem-cell therapies. "I think this is a very positive start, but the expectations and hype I see around stem-cell therapies are the same that I saw around gene therapy."'
And so it goes.

July 31 2010 at 1:01 PM Report abuse +1 rate up rate down Reply
Mary Elaine

Now that the FDA has approved the use of embryonic stem cells in humans, how is it, as the Times reports, not destroying human life in the cells themselves, please explain this?

July 31 2010 at 6:23 AM Report abuse -4 rate up rate down Reply
wbischo

I am so happy to see this country finally beginning to see the possibilities which stem cells offer mankind. If you believe in God, and are against this type of research to aid humans, you must not believe that God is as great as He really is. Only God could have designed our bodies so that we can use human stem cells to repair ourselves. This didn't happen by accident. God, himself, planned it for us.

July 31 2010 at 1:47 AM Report abuse +2 rate up rate down Reply
1 reply to wbischo's comment
Mary

Pro lifers have and still protest the use of embyonic stem cell experiments.Adult stem cell has cured people embryonic stem cells have yet to cure anyone.

July 31 2010 at 4:55 PM Report abuse rate up rate down Reply
cosmo2001

It's about time!... Once this research is more advanced, it'll be the medical equivalent of us landing on the moon. Millions of lives will be saved or made better. At some point this will lead to Much longer lives, less suffering, and (eventually) to Commercial Biological Immortality for those who desire it for themselves...
However, now, with people living longer, we have to figure out how we're gonna feed everyone..

July 31 2010 at 12:08 AM Report abuse +4 rate up rate down Reply
viking9343

Another drain of tax dollars chsing the foolish. If this was good science the privaite sector would be all over it. It isn't.

July 30 2010 at 8:50 PM Report abuse -16 rate up rate down Reply
1 reply to viking9343's comment
bagadoughnuts3

The biopharmaceutical company Geron Is the private sector!!!!!

July 30 2010 at 9:17 PM Report abuse +10 rate up rate down Reply
BONNIE

THANK G-D THE FDA FINALLY WOKE UP!! WE ARE 15 YEARS BEHIND OTHER COUNTRIES ON TRYING TO FIND CURES FOR DISEASES, AND IT IS ABOUT TIME, WE OPENED THE DOOR AS WELL!! MAYBE NOW WE CAN FIND SOME HELP AND CURES ON ALOT OF THESE DISEASES, AND ANYONE WHO IS AGAINST THIS, AND HAVE A DISEASE, CAN STAY THAT WAY IF THEY WANT, BUT DO NOT TAKE AWAY THE HOPE OF OTHERS THAT WANT THIS!!!!!

July 30 2010 at 8:48 PM Report abuse +7 rate up rate down Reply
1 reply to BONNIE's comment
dusty754

It isn't the FDA that was slowing the process. It was the bible thumpers. THese mental midgets actually believe that embryoes used in invitro fertilization are kept forever. What actually happens is several ova are fertilized and some are planted into the uterus. The others are kept for a short time but they cannot be kept forever and are destroyed. The bible thumpers could not grasp the fact that the embryoes that were going to be destroyed could be used for other things and their existence would not be in vain.
The funny thing about oranized religion is that it seems to be the cause of more problems than it supposedly prevents.

July 31 2010 at 2:09 AM Report abuse +5 rate up rate down Reply

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