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.’”

[OneWingedShark]

So then, did they break the law with respect to the ban on embryonic stem-cell research?

And, given my experiences with government, NOTHING of the scale of a big project like this would EVER get done in 3 days.

Something smells rotten here...

[nutmeg]

Why is anyone surprised? ELECTIONS HAVE CONSEQUENCES.

That's right, Hildy. That includes those "principled" types who vote third party, or who "stay home" on election day, enabling 'RATs to acquire more power.

[silent_jonny]

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. White House photo by Kimberlee Hewitt

[STARWISE]

No Need For Embryonic Stem Cells

###

STEM CELL RESEARCH — (House of Representatives - September 10, 2008)

---

The SPEAKER pro tempore. Under a previous order of the House, the gentleman from Florida (Mr. Weldon) is recognized for 5 minutes.

Mr. WELDON of Florida . Mr. Speaker, this summer has been a breath-taking one for stem cell researchers around the world, but not because of embryonic stem cells or cloning. Building on important work published last year showing that it is possible to reprogram an adult cell back to its primitive embryonic-like state, researchers led by Doug Melton at Harvard University have done what was thought impossible only a few short years ago.

Melton and his team used mice to show that it is possible to directly reprogram support cells or exocrine cells of the pancreas into insulin-producing beta cells without ever removing any cells from the pancreas.

Amazingly, it appears that one adult cell type has been directly and specifically transformed into another adult cell type.

In other words, a simple injection of three critical reprogramming factors successfully produced insulin-producing beta cells and gave patients with diabetes and their families new reason to hope in the power of regenerative medicine.

Melton and his colleagues have brought us one step closer to what many have called the ``holy grail’’ of regenerative medicine.

He has shown that, in principle, it is possible to induce the body to heal itself by reprogramming one cell type into another.

Imagine that; your beta cells can no longer make insulin and you are diabetic, perhaps because of immune destruction of your insulin-producing cells like in Type I diabetes, or perhaps because, like in Type II diabetes, your insulin-producing cells have just given up.

If the work Melton describes can be reproduced in human patients, diabetes patients would have to receive a simple injection, maybe two or three times, and with that, their pancreas could resume producing insulin and they would be cured of their diabetes, no longer requiring insulin injections, no longer requiring painful pinpricks.

Of course, Melton’s work is a long way from the clinic. Mice are not people, and some of the details must be modified to ensure that the injection is safe and won’t cause tumors.

But this work represents an enormous step forward and should be pursued with all of the resources NIH can provide.

This exciting news comes on the heels of another announcement also this summer, that researchers from Harvard and Columbia have used the reprogramming protocol to create 21 disease-specific stem cell lines that will enable researchers to intimately study diseases such as Lou Gehrig’s disease, Type I diabetes, Parkinson’s and muscular dystrophy.

And it is important to note that this technique also

***does not require the creation, destruction or even the presence of human embryos.***

These cells may not be ready to transplant into humans in the near term, but they will be available for research today and for use in screening for drugs.

So in a few short months, the promise of regenerative medicine comes closer to reality. Just last year, scientists and cloning advocates told us that we had to do human cloning—or at least to create cloned human embryos—so that we could accomplish these two goals that were deemed essential for moving regenerative medicine forward; creating disease-specific cell lines, and regenerating stem cells that could be a perfect match for patients affected by these diseases.

Both of these goals have been accomplished with the reprogramming protocol; no cloning, no human embryo stem cells required. To say it another way, there is no medical reason to proceed with research into cloning human embryos for their stem cells because that science is obsolete, it is more cumbersome, it is more expensive. We have a better, quicker, easier way to do it.

Rest here:

http://www.lifewatch.org/noneedforembryos.html#STEM_CELL_RESEARCH

[jveritas]

Thank you Johnny for this very nice post. I greatly missed President Bush.

[STARWISE]

Praise the Lord for Pres. Bush. Sad ... sad
turn of events. Zero just couldn’t wait to
jump on it and start the destruction.

[Western Phil]

“So then, did they break the law with respect to the ban on embryonic stem-cell research?”

I think the ban was on using our tax money for the reasearch, not on the research itself.

[OneWingedShark]

>>“So then, did they break the law with respect to the ban on embryonic stem-cell research?”
>
>I think the ban was on using our tax money for the reasearch, not on the research itself.

I see. Too bad... I’m in the mood to see heads crushed on a REAL moral high-ground.

[STARWISE]

“As to diseases,
make a habit of two things—
to help, or at least do no harm.”

###

Human Pluripotent Stem Cells without Cloning or Destroying Embryos

Stem cell research and resources

http://www.stemcellresearch.org/

[Amelia]

Zero just couldn’t wait to jump on it and start the destruction.

Not defending Obama, but I doubt he had anything to do with it.

The company had to have been doing this research for quite a while. The research itself was not banned, it's just that federal money couldn't be used to pay for it.

[STARWISE]

Adult stem cells still trump embryonic

http://www.mercatornet.com/articles/adult_stem_cells_still_trump_embryonic/

[My Favorite Headache]

Ya know...the year 1984 is my favorite year ever...but the book...yeah..it’s coming to life.

[DrDeb]

THANK YOU for the photo and the alert . . . We have replaced a godly man who values ALL life (particularly the most innocent and vulnerable among us) with a secular man who values no life unless that life serves some utilitarian purpose, e.g., voting ‘Democrat’ on election day.

I miss President Bush more and more every day!

[STARWISE]

Right .... now, we get to pay for the killing.
That’s a HUGE contrast to Pres. Bush’s ethics.

[Darkwolf377]

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.

Yes, but the crowd that delighted in calling him Jorge are happy. That's so much more important than having a consistent defender of human life in the WH.

McCain is many things I disagreed with, but he has a pretty good record on life issues. His choices for SCOTUS might not have been perfect if he made them, but...well, you know the rest.

[ga medic]

Embryonic stem cells have to be harvested at a particular point in development. I believe that the embryo must be around 4-5 days old, for truly embryonic stem cells to be harvested. Any later and the cells are no longer pluripotent, and would be considered adult stem cells. The article didn’t make that very clear, but scientifically that is the only way it can work.

[omega4179]

Aside from his supporting Amnesty and this Stimulus, I will miss GWB a lot.

Embryo to Bush= A Human life
Embryo to Soetoro= “Punishment” or a lab experiment

[gwilhelm56]

**The Embryonic Stem Cell Research gets us nowhere.**

Private firms have been working on Embryonic Stem cell all along. THe Federal did not BAN research .. it just banned Federal $$$ for research.

So far, ALL EMBRYONIC Tests have caused 1 thing 100% of the time... CANCER!! ADULT Stem cell research, however, has paralyzed people able to move their feet.

[SoldierDad]

The fight just got much harder. Stay the course - God IS on our side.

[plain talk]

Thank you Johnny for this very nice post. I greatly missed President Bush.

I guess I trashed him as much as anyone given my disappointment on many issues. But good grief. After the last few weeks I dearly miss the man. What we face is much worse than I expected.