DawgTalkers.net Forums DawgTalk Tailgate Forum FDA approves human embryonic stem cell study

http://www.cnn.com/2009/HEALTH/01/23/stem.cell/index.html

(CNN) -- Federal regulators have cleared the way for the first human trials of human embryonic stem-cell research, authorizing researchers to test whether the cells are safe to use in spinal injury patients, the company behind the trials announced Friday.


Embryonic stem cells are blank cells found in embryos, which have the ability to turn into any cell in the body.

The tests could begin by summer, said Dr. Thomas Okarma, president and CEO of the Geron Corporation. The Food and Drug Administration has approved the trials, which will use human stem cells authorized for research by then-President George W. Bush in 2001.

The patients will be those with the most severe spinal cord injuries, called complete spinal cord injuries.

"A complete spinal cord injury has no hope of recovery below the injury," Okarma told CNN. "This is significant because it's the first clinical trial of a human embryonic-based product." Watch more on stem cell research »

The primary purpose of the trial will be to see whether injecting these cells into patients is safe, but Okarma said researchers will also look for any signs of recovery. Scientists will monitor the patients for a year after the injections to see if they are regaining any function below the injured point.

"If there is any movement below the injury, they will measure that and record it," he said.

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The trials will involve eight to 10 patients who are completely paralyzed below the third to tenth vertebra, and who sustained their spinal cord injury within seven to 14 days. The tests will use stem cells cultured from embryos left over in fertility clinics, which otherwise would have been discarded.

Using the stem cells, researchers have developed cells called oligodendrocytes, which are precursors to nerve cells and which produce a protective layer around nerve cells known as myelin. Researchers will inject these nerve cells directly into the part of the spine where the injury occurred.

Embryonic stem cells are blank cells found in four- to five-day-old embryos, which have the ability to turn into any cell in the body. However, when stem cells are removed, the embryo is destroyed -- which has made this one of the most controversial medical research fields in the past decade.

Federal research funds were prohibited for embryonic stem-cell research until August 2001, when Bush approved spending for research using only already-existing cell lines. Scientists later discovered that fewer than two dozen of those lines were useful for research, but abortion opponents opposed any legislation that would lift Bush's restrictions, and Bush twice vetoed congressional efforts to roll back his rules.

President Obama is expected to loosen the restrictions, which many researchers and advocates have complained severely set back work toward curing disease such as Alzheimer's, Parkinson's and diabetes.

Okarma said Geron did not use any federal funding for its research, and that the Bush restrictions had "devastated the field."

"People didn't think this would happen for another five years," Okarma said. "But it will happen soon, and it would have happened sooner if it weren't for the ridiculous Bush policies."

Geron owns patents on and licenses the procedure to make these stem cell lines. The company spent $45 million of its own to produce everything required to get approval for the upcoming trial, Okarma said.

At least two other companies have said they plan to begin conducting embryonic stem-cell tests in humans, but only Geron has received FDA approval. Another U.S. company, Reneuron, plans to conduct trials involving stem cells taken from fetal tissue in Britain this year. Other companies have developed stem cells from adult tissue, sidestepping the controversy.

In addition to producing stem cells to treat spinal cord injuries, Geron says, it has seven other types of cells derived from stem cells in its pipeline. Okarma said FDA scrutiny was stringent, and that researchers studied the cells in petri dishes and in animals before obtaining permission to test them in humans.

Getting approval was made harder and took longer because the FDA had no other peer-reviewed research outside of Geron's to consult as it reviewed the proposal, he said.

The trials are not expected to start until summer, because many of the preparations could not begin until Geron had FDA approval, Okarma said. Researchers have to be educated about how to use the stem cells, how to prepare their laboratories for the research and how to read all the magnetic resonance imaging (MRI) of the patients in the same way.

"We [also] have to train surgeons how to inject the stem cells," Okarma explained. His company even developed a device that is mounted to the operating table to help surgeons inject the stem cells.


Geron still has to select the four to seven sites for the clinical trials, Okarma said.

The first human embryonic stem cells were developed by Jamie Thomson at the University of Wisconsin-Madison in 1998.


I'm curious to hear others opinions on an ethical/political matter such as this. It's a very slippery slope IMO. One that we'll be crossing here pretty soon. At what point do we say, its gods will? And when do we intervene and play god? I mean there might be a time in our lives where we could potentially live forever if this science continues to grow. Tickers bad... we'll grow a new one. You've got T1 diabetes. Here is a new pancreas.

Secondly, should this be a political question at all? If a group has private funding, should we step in and tell them it's not morally right?

Being a big Catholic, I'm against all stem cell research.

I married a Catholic,...she is the best at EVERYTHING life has to offer. Kind, sweet, loving, compassionate, and she puts up with me.

I would sell my soul to the devil if stem cell ever saved her life.

I have lost a brother to MS, one to AIDS, and have a Mom and a sister with breast cancer. It's a wonder I never got killed in combat with that kind of "luck."

Stem cell researchers are underpaid,...

About time . Just hope that the advancements come in time to help me out when I get older and need some new parts. Who wants to live forever ? Me.

Good for them. About time this research got going.

Born and Raised Catholic... But never have I ever believed that the teachings of the Catholic church are perfect.

Today, there may be a way to relieve suffering, prolong life and improve quality of life through Stem cell research.

I know it's hard for some to accept.. But I honestly believe this is for the better.

Even the ones that come from your nose???? I mean I understand being against "embryonic" stem cells. But it is not the only place to get them...

Well, I have to be honest. I have always been against embryonic cell research. Now that I have cancer and am fighting for my life, would I still be against such research if it could save MY life? The answer is yes. I would rather lose the battle I am in then to use this type of treatment to live. I am not against all stem cell research, but I do not endorse this at all, even if it meant I could win the battle I'm in.

Can't say that I am for or against STEM CELL research.

Embryonic stem cells, again, I don't know, I could go either way I guess. Taking cells from a baby in the womb? Totally against it.

Okay, that's out of the way.

One problem with stem cell research is, and the researchers have admitted it, they currently have no way of knowing if the cells they get are good - with no cancer.....they don't know too much about them.

We will always have life, and we will always have death, and even stem cells, be they embryonic or not, will not change that. Sure, some people may live longer IF it comes to fruition the way some dr.'s and scientists envision. However, the complications that may come with this might be overwhelming. Life is about living. Death is about attaining eternal life.

There, all you haters can flame away at me.

I am absolutely opposed to embryonic stems cells. I don't like the idea of a living thing that could one day develop into a human being harvested for use. Even if you agree to the procedure itself, you can't deny that it's a slippery slope to say the least. Besides, I thought that adult stem cell research was more promising anyway and unlike embryonic, a living thing doesn't need to be destroyed to get them. Anyone know more about the topic that can expand on it?

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Death is about attaining eternal life.

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Sticky issue. I'm not opposed to stem cell research in and of itself but I'd be lying if I said it didn't scare the heebie jeebies out of me where this might lead. Especially with respect to where the stem cells come from....

I will just leave it at this, the very first time an embryo is created for the sole purpose of harvesting stem cells, we've gone too far.... unfortunately at that point, I doubt we will be able to turn back.

So it needs to be legislated so there are no Hitler remakes,....hopefully no one can clone Braylon Edwards either,....

The idea is to fight disease, no ??

I don't see the problem.

exciting news....it's good to see one of the most promising scientific studies finally get underway.

I'm not in the field enough to know about the differences between embryonic and adult stem cells. Due to the difficulty in obtaining embryonic stem cells, my guess is that they offer some huge advantage over adult cells, otherwise researchers wouldn't spend years trying to fight through regulations to get them.

A couple other notes....this research was legal under the bush regime, because it's using one of the 21 approved stem cell lines, first created in the early 90s.

Secondly, we'll never get to the situation where we're running out of stem cells, once you extract stem cells they can be bred forced to divide for some time. All stem cell research currently done works off of only 21 sets of stem cells (that is, are from 21 embryos). Only in the last couple years have those lines began to be exhausted (forcing the cell lines to multiply tens of thousands of times starts to introduce genetic errors because cell replication is not always perfect)....

However, when we're talking about stem cell research, even if these cells were to be used on a daily basis, we still have thousands of times more embryos discarded anyway (abortions, miscarriages etc).... than we will ever use for stem cells.

Lastly, as I just noted, these are embryos that are discarded anyway...sometimes they died naturally, sometimes it was abortion. There's no need to kill an embryo to further stem cell research, on the other hand it could save millions.

~Lyuokdea

I'm Catholic,

but I support Stem Cell research all the way.

Ok now that I've got a few replies... I know everyone is probably dying to find out my opinion.

I'm for adult... and for those who don't know. There are few different ways that I know researchers can obtain stem cells. An embryos cells which results in a killed fetus, adult cells (tissue, blood, bone marrow, umbilical cord), and embyonic fluid (NEW).

As I'm typing this about being against embryonic cells I now notice the hypocrisy in my views. As I'm pro-choice. And really there is no difference. Except it probably has the potential to happen more... and it has the potential to save an existing life... 1 existing - 1 new = 0 as opposed to 0 - 1 existing = -1

The second one way, adult is actual already in use today. Like for bone marrow transplants and such. To me this is in line with much of the medicinal practices we've been practicing since mankind. The problems with this type is its "potency" is lower than with the other two. Meaning, the cells really can only turn into the same type or similiar types as it was before.

The new method of extracting embronic fluid to me sounds like we might be stealing from the babies nutrients. Thus, we could be hurting the unborn child and he/she would be missing half a brain when born. Thats just me thinking logically. I'm no medical scientist... I think we'd have to do more research there before I'd consider that safe.

But, to really answer my questions think about there being some way to extract a totally potent stem cell and it has no affect on any living thing. Now...

At what point do we say, its gods will? And when do we intervene and play god?

Allthough this has been played out in science fiction movies and books... it's not too far off base from happening here soon. We're only at the tip of the iceburg when it comes to stem cell research. To me it's scary scary stuff.

I don't understand your points....it's not like we're taking babies that mom's want to have and then killing them to harvest stem cells.

We're basically taking discarded fetuses (already dead for an hour or so), poking them with a syringe to remove some cells, and then placing them in the crematorium where they were going anyway.

Even if we were to outlaw abortion, we could just use completely natural miscarriages and obtain the same results, again, without killing anything that is alive (because the baby is dead before you decide to harvest the stem cells)

I completely fail to see how harvesting stem cells from a baby amounts to playing god, any more than administering antibiotics or performing surgery on an adult.

~Lyuokdea

I didn't think of that... I mean I thought of an aborted childs stem cells. But I guess if the actual stem cells are on an embryo or placenta then it wouldn't matter if the fetus wasn't alive. So for all of those who have had miscarriages (which by the way I had no idea how common they were until my wife and I had children).. abortions ... we'd actually be on the good side of my equation (1 existing - 1 new = 0)

To answer your question about why scientist want to use embryonic cells.. its because of their potency. They can essential turn into any other cell in the human body. While others are rather limited.

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don't understand your points....it's not like we're taking babies that mom's want to have and then killing them to harvest stem cells.

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read my reply above...

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I completely fail to see how harvesting stem cells from a baby amounts to playing god, any more than administering antibiotics or performing surgery on an adult.

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My point is.. this has the potential to be much more substantial than an antibiotic. If we could just regenerate new cells in our bodies we'd never get old, thus never die. Maybe I've watched the scifi channel too much

This is long overdue. One of my biggest disagreements with Bush was on his stance against this.


To the question of should this be a political issue at all? Yes, it should, simply because it does run directly acros a LOT of ethical lines, and a line will have to be drawn in concrete at some point that no one will be allowed to cross. What that line will be and when it will come is anyone's guess, but as you've already pointed out, there will be issues that will potentially have very severe ramifications that will take very serious and deliberate debate to work through.

Everything is a trade off of choices. You trade one step down a staircase of ethical compromise for one step up in medical advancement. At some point, the price for that next step will be enough that a line will be drawn and laws will be made.

It's high time, I'm all for it.

I am all for advancing science. In fact I have no problem cloning, we have technology which can blow up the world we can't become anymore dangerous than we already are.

Also my belief is, if god has a problem with what were doing he will stop it. Until then he either doesn't mind or is ambivalent.