Diagnosed in 2005 with multiple sclerosis, Sam Herrell had few options available to him in the U.S., his home country. Now, however, he is traveling to Central America in order to receive an adult stem cell therapy that was pioneered by American doctors but which is not yet available within the United States.
A proud native of Texas, the Ennis Lions football coach has decided to travel to ICM – the Institute for Cellular Medicine – in Central America for treatment with his own adult stem cells. The ICM has an 80% success rate with its patients, but don’t expect the treatment to be available any time soon within the U.S., since the U.S. FDA (Food and Drug Administration) has made such a procedure legally impossible for doctors to conduct within the United States. Specifically, the FDA has decreed that autologous (in which the donor and recipient are the same person) adult stem cells must be classified and regulated as a "drug", and therefore cannot be used as a clinical therapy until first being subjected to the ordinary FDA laws that govern pharmaceutically manufactured drugs, which is a process that typically requires a decade or more of testing before approval can be obtained. Most patients, with multiple sclerosis as well as other diseases or injuries, cannot wait a decade or longer for treatment, so they are following the U.S. doctors who have set up their clinics outside of U.S. borders. If the FDA would only change their stance on this critically important issue, then the U.S. doctors who pioneered this adult stem cell treatment would be able to administer the therapy within the U.S., and then perhaps there wouldn’t be such an endless debate over embryonic stem cells, which still have years if not decades left before they could be considered for use in clinical therapies. Unlike embryonic stem cells, adult stem cells are already being used in clinics around the world to treat real people with real diseases – but not within the U.S., except for the very limited number of FDA-approved clinical trials that are being conducted.
As Sam Herrell explains, "The thing that’s kind of disappointing is that the neurologists here have nothing that really gives you much hope. All they can do is say keep on this medication and hope it slows down, hope it doesn’t overtake your whole nervous sytsem before they find a cure. Outside the U.S., some things are being done that people have had phenomenal results with, and that’s been encouraging. I really think there’s going to be a cure for it – that’s what I’m hoping for. It’s been encouraging to hear those stories and talk with people."
A number of scientific studies in the medical literature support such claims, not the least of which is an article that was published in the Journal of Translational Medicine in April of 2009, entitled, "Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis", by N.H. Riordan et al., in which scientists and doctors elucidate the various cellular and molecular mechanisms that are at work when this type of autologous adult stem cell therapy is implemented as a treatment for multiple sclerosis. Additionally, 3 case studies are described in the paper in which patients with multiple sclerosis showed significant improvement after receiving such a treatment. Of particular significance are the unique immunomodulatory properties of this therapy, which play an especially vital role in a disorder of autoimmune origin such as multiple sclerosis.
In specific reference to ICM, Mr. Herrell adds, "I’ve heard of two different procedures I really think I’ll try. It’s very expensive, but that’s a hurdle I can try to tackle for hope of a cure. I get excited when I talk to those people who have gone outside the country, because they’ve come back with a story of hope. I’m still hopeful for a cure. I’m serious about that. These people who have tried some of these things, they don’t feel better, they feel cured. That’s what I’m hoping for. Then I can still live in Texas."
However, the U.S. FDA still insists that the cells within a person’s own body are "drugs" and therefore cannot be administered, not even to that very same person, for therapeutic purposes until first being subjected to the exact same multi-year, multi-million dollar approval process by which the pharmaceutical industry is regulated. Unless the FDA ever changes its position on this issue, people such as Sam Herrell will be forced to travel outside of the U.S. in order to be treated with their own, autologous adult stem cells.
Fortunately, at least such therapy does exist somewhere in the world, even though not in the United States.