Another reason why this shouldn't be a debate...

Atlanta, Georgia -- Imagine having your back cut open, part of your spine removed, a stabilizing device that resembles a mini oil rig mounted on your back, the outer membrane of your spinal cord sliced open and experimental stem cells injected into it -- all for the advancement of science because it's not expected to benefit you.

John Cornick, 51, did just that earlier this month as part of a groundbreaking clinical trial.

Almost a year ago, Cornick was told he had ALS -- better known as Lou Gehrig's disease. The diagnosis left him "fairly devastated," he says.

He knew the prospects were grim because there is no cure.

But John wasn't giving up so quickly, nor was his wife, Gina.

"I knew he was a fighter from the beginning and he really wanted to do something," Gina Cornick says. She found information about a clinical trial on online and immediately signed him up, even though she had no idea where it was being held.

ALS destroys the nerve cells in the brain and spine which control muscle movement. When the brain can no longer tell muscles to move, they eventually die, depriving the patient of the ability to move arms and legs and eventually breathe.

The goal of this phase 1 trial is to determine whether fetal stem cells can safely be injected into the spinal cord. Ultimately, researchers hope to show that these cells may slow or halt the progression of the fatal disease.

But for now, the only goal is establishing safety.

Clinical trial

The Cornicks live in North Carolina, just a few hours from Atlanta, Georgia's Emory University, the site of the trial. It is the first FDA-approved clinical trial to inject fetal stem cells directly into the spinal cord of an adult.

Dr. Jonathan Glass, director of Emory's ALS center, is overseeing the trial. Cornick and two previous patients in the trial are heroes, says Glass, because at this point, the trial will likely produce only information, not results.

"In reality what do these patients have? Time, families and their life and we're putting all of these at risk," says Glass.

Dr. Lucie Bruijn, science director of the ALS Association, says the progress being made in this clinical trial is exciting. "We've been able to move it forward ... from animal testing now into actual patients." The treatment had not been tried in humans before.

Glass hopes this trial will lead to a new form of treatment for people with ALS. "We're testing multiple things: We're testing the safety of the surgery; we're testing the cells; we're testing immunosuppressants[because scientists do not know whether the body will reject the cells]." They are also testing how well Cornick handles this major surgical procedure, says Glass.

"After we're finished with the first 12 or 18 patients we will know whether this is surgery that patients can tolerate."

As he was prepped for surgery, Cornick was hopeful but realistic. "Well, of course you'd like to get up and walk ... but I know that's not going to happen."

Stem cells

The stem cells used in the surgery are shipped overnight from Maryland, where Neuralstem, the company funding the trial, is based. The stem cells' source is donated tissue from the spinal cord of an 8-week old aborted fetus, which was donated to the company. The company has developed a method that enables growth of millions of stem cells from this single source of human nerve stem cells.

Before the surgery can begin, a technician at Emory has to verify that a majority of stem cells made it to Atlanta alive. At least 70 percent have to be viable. In this case three samples under the microscope showed 85 percent of the cells arrived alive.

Lead researcher Dr. Eva Feldman, a neurologist at the University of Michigan, designed the trial just four years ago. After a lot of animal testing, her team determined that using fetal nerve stems rather than human embryonic or adult stem cells (such as bone marrow stem cells) was most effective, she says.

Stem cells have the ability to turn into different cells in the body. However, human embryonic stem cells, which come from 4- or 5-day-old embryos, also been found to sometimes turn into cancer cells. Fetal stem cells, such as those used in this trial, are a few weeks older and have already taken on a specific identity -- in this case nerve cells.

Feldman says the fetal stem cells used in this trial did not become any of the unwanted cell types. "That's very, very important," she says.

Surgery

Animal testing also proved very useful when it came to figuring out how to actually inject the stem cells. Emory University's neurosurgeon Dr. Nicholas Boulis invented the device that holds the needle that injects the stem cells. The goal is to inject the cells without injuring the spine and causing even more paralysis. He practiced on 100 pigs before attempting the procedure on a human.

Boulis says it's critical that the injection be done in a very slow and controlled way.

"If you inject quickly, you're going to create pressure at the head of the needle and that can cause damage," Boulis says. That pressure can also inflate an area in the spinal cord which could cause the stem cells to seep back out of the cord when the needle is pulled out, he says. "So by pumping [cells] in slowly you have more security that you are not going to have reflux and you're not going to have damage."

Dr. Jeffrey Rothstein, who heads the ALS research center at Johns Hopkins University and is not connected to this trial, said work on this method is a big achievement. "This is purely about how to surgically deliver cellular therapy to spinal cord," he says. "It's never been done before."

After the spinal cord was exposed, the injections began. Cornick got five -- each one contains about 100,000 stem cells.

The four-and-a-half hour surgery went smoothly, Boulis, says. "There were no surprises."

Post-surgery

A day after surgery, Cornick was lying flat in a hospital bed, chatting and laughing with some friends from North Carolina.

One week after surgery, he says he felt amazingly well and was still hopeful the cells would do some good for him.

Two weeks later Cornick's stitches were removed and he was able to drive home. But he will be making frequent visits back to Atlanta as Glass and his team continue to monitor him.

Neuralstem's Chief Scientific Officer Karl Johe says after the trial's safety board reviews all existing data, including Cornick's results, a fourth patient can be treated with the stem cells.

"Patients Four, Five and Six will receive twice as many [stem cell] injections," Johe says. They will get five more injections on the other side of the spinal cord compared with Cornicks's surgery.

Cornick expects the researchers will follow his progress for a long time. He says he understands the need for people to be willing to participate in experimental research like this.

"For me it just seemed like the right thing to do. I almost felt I had an obligation to do this," he says. "To help other people and myself."

Stem cell treatment goes from lab to operating room - CNN.com

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The stem cells' source is donated tissue from the spinal cord of an 8-week old aborted fetus,

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This is where the debate comes from. Not using stem cells but where they come from.

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Originally Posted by TheBeast

This is where the debate comes from. Not using stem cells but where they come from.

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Donated stem cells that would be tossed otherwise, the most common sense issue I've ever seen.

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Originally Posted by R13

Donated stem cells that would be tossed otherwise, the most common sense issue I've ever seen.

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The issue is that they should have never been available for donation because there never should have been an abortion to begin with. There are other ways of getting stem cells without using embryos. The best place to get them is from the patients own body from bone marrow or peripheral system. They are plentiful and are an exact match with no chance of rejection.

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Originally Posted by TheBeast

The issue is that they should have never been available for donation because there never should have been an abortion to begin with. There are other ways of getting stem cells without using embryos. The best place to get them is from the patients own body from bone marrow or peripheral system. They are plentiful and are an exact match with no chance of rejection.

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That's one way of getting them, it's centered around donated embryos from the In Vitro Fertilization procedures. Your problem is an abortion issue, not a stem cell issue. Ban abortion and they still happen just as much, with increased mother deaths dramatically, we're not a 3rd world country. And no, that's a completely different kind of stem cell, those aren't embryonic and have less of the possibilities, they're only really used for cancer treatments. It's hardly simple to extract them either, day long process and usually don't get enough after one harvest. Completely different thing, so that goes out the door.

You still don't get it. You do realize that donated embryos from in-vitro are still aborted humans beings. This is the problem you have people wanting to do in-vitro just so they can take the embryo and "donate" it for stem cell's.

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Originally Posted by TheBeast

You still don't get it. You do realize that donated embryos from in-vitro are still aborted humans beings. This is the problem you have people wanting to do in-vitro just so they can take the embryo and "donate" it for stem cell's.

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According to you, by law and common sense they aren't. Obama set strict guidelines, only embryos that would OTHERWISE BE DESTROYED could be used. And in-vitro isn't cheap, incredibly expensive, do you actually think without the rules that really anyone would be doing that? A lot of assumptions that are backed up by nothing.

LOS ANGELES - Dozens of people who were blinded or otherwise suffered severe eye damage when they were splashed with caustic chemicals had their sight restored with transplants of their own stem cells ? a stunning success for the burgeoning cell-therapy field, Italian researchers reported Wednesday.

The treatment worked completely in 82 of 107 eyes and partially in 14 others, with benefits lasting up to a decade so far. One man whose eyes were severely damaged more than 60 years ago now has near-normal vision.

"This is a roaring success," said ophthalmologist Dr. Ivan Schwab of the University of California, Davis, who had no role in the study ? the longest and largest of its kind.
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Stem cell transplants offer hope to the thousands of people worldwide every year who suffer chemical burns on their corneas from heavy-duty cleansers or other substances at work or at home.

The approach would not help people with damage to the optic nerve or macular degeneration, which involves the retina. Nor would it work in people who are completely blind in both eyes, because doctors need at least some healthy tissue that they can transplant.

In the study, published online by the New England Journal of Medicine, researchers took a small number of stem cells from a patient's healthy eye, multiplied them in the lab and placed them into the burned eye, where they were able to grow new corneal tissue to replace what had been damaged. Since the stem cells are from their own bodies, the patients do not need to take anti-rejection drugs.

Adult stem cells have been used for decades to cure blood cancers such as leukemia and diseases like sickle cell anemia. But fixing a problem like damaged eyes is a relatively new use. Researchers have been studying cell therapy for a host of other diseases, including diabetes and heart failure, with limited success.

Adult stem cells, which are found around the body, are different from embryonic stem cells, which come from human embryos and have stirred ethical concerns because removing the cells requires destroying the embryos.

Currently, people with eye burns can get an artificial cornea, a procedure that carries such complications as infection and glaucoma, or they can receive a transplant using stem cells from a cadaver, but that requires taking drugs to prevent rejection.

The Italian study involved 106 patients treated between 1998 and 2007. Most had extensive damage in one eye, and some had such limited vision that they could only sense light, count fingers or perceive hand motions. Many had been blind for years and had had unsuccessful operations to restore their vision.

The cells were taken from the limbus, the rim around the cornea, the clear window that covers the colored part of the eye. In a normal eye, stem cells in the limbus are like factories, churning out new cells to replace dead corneal cells. When an injury kills off the stem cells, scar tissue forms over the cornea, clouding vision and causing blindness.

In the Italian study, the doctors removed scar tissue over the cornea and glued the laboratory-grown stem cells over the injured eye. In cases where both eyes were damaged by burns, cells were taken from an unaffected part of the limbus.

Most patients regained sight
Researchers followed the patients for an average of three years and some as long as a decade. More than three-quarters regained sight after the transplant. An additional 13 percent were considered a partial success. Though their vision improved, they still had some cloudiness in the cornea.

Patients with superficial damage were able to see within one to two months. Those with more extensive injuries took several months longer.

"They were incredibly happy. Some said it was a miracle," said one of the study leaders, Graziella Pellegrini of the University of Modena's Center for Regenerative Medicine in Italy. "It was not a miracle. It was simply a technique."

The study was partly funded by the Italian government.

Researchers in the United States have been testing a different way to use self-supplied stem cells, but that work is preliminary.

One of the successful transplants in the Italian study involved a man who had severe damage in both eyes as a result of a chemical burn in 1948. Doctors grafted stem cells from a small section of his left eye to both eyes. His vision is now close to normal.

In 2008, there were 2,850 work-related chemical burns to the eyes in the United States, according to the Bureau of Labor Statistics.

Schwab of UC Davis said stem cell transplants would not help those blinded by burns in both eyes because doctors need stem cells to do the procedure.

"I don't want to give the false hope that this will answer their prayers," he said.

Dr. Sophie Deng, a cornea expert at the UCLA's Jules Stein Eye Institute, said the biggest advantage was that the Italian doctors were able to expand the number of stem cells in the lab. This technique is less invasive than taking a large tissue sample from the eye and lowers the chance of an eye injury.

"The key is whether you can find a good stem cell population and expand it," she said.

Stem cells restore sight to those blinded by burns - Health care- msnbc.com

Scientists have successfully regenerated the limb joints of animals with stem cells, giving hope to arthritis patients who need joints replaced.

In a new study in the Lancet, researchers from Columbia University Medical Center, the University of Missouri and Clemson University showed that they had regenerated limb joints of rabbits using the animals' own stem cells.

Here's how it works: Researchers took out the end of the rabbit?s forelimb joint. Using laser scanning, they were able to reconstruct, using a computer, a 3-D image of what the joint looked like. Based on that image, they "printed" a scaffold that is the same shape of the joint, using a machine somewhat akin to a computer printer. The scaffold is made of polymers that have tiny tunnels in them.

Next, the researchers put the scaffold into the place where the joint was. They inserted a special peptide - part of a protein - inside the tunnels of the scaffold that recruits stem cells to regenerate the joint. After growing the joint, the rabbits were able to move again normally, the study said.

This is the first time that limb joints have been regenerated from an animal's own stem cells, not cells that were harvested elsewhere, said study co-author Dr. Jeremy Mao of Columbia University. The animal's ability to function again normally after growing the limb joint has also never been accomplished before.

Of course, this has not been yet shown in humans, and the researchers did not take into account the rehabilitation process that a patient would need to go through to get accustomed to the new joint, Mao said. In rabbits, growing the joint took about three weeks on average - it could take longer in humans.

Currently, people with damaged joints must get a metallic replacement that lasts only 10 to 15 years.

Mao could not predict how many years away this joint replacement technology is for humans, as it depends largely on the regulatory process of the U.S. Food and Drug Administration. The next step would be to test it on a larger animal, perhaps a goat because goats also get arthritis.

Growing joint with stem cells possible, study says – Paging Dr. Gupta - CNN.com Blogs