MY STEMS

[locksflooring]

Stem cell treatment still a way off in U.S.
FDA says therapy doesn't work now, may be dangerous
By Christina E. Sanchez • THE TENNESSEAN • August 1, 2010

Stem cell treatments have been researched legally in the United States for decades, but they are still out of reach at home for Americans who seek alternative treatments to debilitating diseases.
http://www.tennessean.com/article/20100801/NEWS01/8010362


In other countries, stem cell transplants are used to treat conditions such as Parkinson's disease, multiple sclerosis, liver cirrhosis, stroke, glaucoma and spinal cord injuries.
But within the United States, stem cell treatments could be a decade or more from approval by the Food and Drug Administration. Doctors say the therapy doesn't work at this time and may even be dangerous.
"If the United States had a promising therapy that had been shown to be effective, it would be using it," said Dr. Mark Magnuson, director of the Vanderbilt Center for Stem Cell Biology. "It's a risky therapy, and not only will it do nothing, but it could do harm."
Related
MS patient goes to Mexico for stem cell transplant, chance to walk again
Dawn Gusty's stem cell transplant
What are stem cells?
What is multiple sclerosis?
Embryonic stem cells are the most controversial because the cells are taken from 4- or 5-day-old human embryos, a method that raises ethical questions. In March, President Barack Obama lifted an eight-year ban on federal funding for embryonic stem cell research.
Adults also have stem cells, which go around the body to replenish other dying cells and to take on specialized jobs, according to the National Institutes for Health.
In Dawn Gusty's case, they could repair the nerve endings that were destroyed by her multiple sclerosis.
"This is all over the scientific world," said Dr. Gustavo Andrade, who performed Gusty's therapy in Tijuana, Mexico. "There are all these things we don't understand yet. Will the cells attach to the inflammation, and for how long? It could be for a long time, it could be a few months, but each patient is different."
'Not the magic bullet'
No one tracks how many people travel outside the United States each year for stem cell transplants, but estimates are at least 800 people. Treatments can cost between $20,000 and $150,000.
This year, Stem Cells for Hope, the New York company that Gusty used, helped 27 patients who went through a review panel of doctors and researchers. They can't be older than 80 and must fit into a category of about eight diseases, said Peter Sidorenko, chief operating officer.
He said most people who seek out the company say, "My doctors said there was nothing they could do for me."
"This is not the magic bullet that is going to cure everything," said Sidorenko, who acknowledges there are companies that scam or lack expertise. "But we are helping people with degenerative diseases. We're just scratching the surface of what this type of medical procedure can achieve."
Magnuson said he doesn't dispute that stem cells hold promise for new therapies in the future — particularly embryonic stem cells, his area of expertise.
"We're 10 to 12 years into this, and that may seem like a lot of time, but what we do takes time," Magnuson said. "Any new stem cell therapy is going to be looked at by the FDA to make sure it doesn't cause more damage than good."
Contact Christina E. Sanchez
at 615-726-5961 or [e-mail].