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Wednesday, August 31, 2016

Welcome or Not, FDA Focuses on Stem Cell Treatments


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News that the U.S. Food and Drug Administration (FDA) is to hold a public hearing next month to consider greater oversight of stem cell clinics operating in the country is as welcome as it is late. I say “late” because, while the regulators have been twiddling their fingers, the stem cell business has been booming across America.
The hearing, to gain public comments prior to preparations of draft guidelines, is being held on Sept. 12 and 13 at the campus of National Institutes of Health (NIH) in Bethesda, Maryland, just northwest of Washington, D.C. (The public is invited to follow the hearing live via a webcast on the FDA webpage announcing it.)
There are now hundreds of clinics, some say as many as 600, that are promoting stem cell therapies to combat everything from aging to autism, Alzheimer’s disease to, even, multiple sclerosis. However, no one should be confused — these clinics are NOT offering HSCT. What they are peddling is some form of stem cell treatment without chemotherapy.
Real HSCT treatment that has shown remarkable success in treating multiple sclerosis includes chemotherapy. This is not just desirable; it is crucial. It is the chemo drugs that do the most important work of suppressing a patient’s immune system before the stem cells help it to grow again, renewed or ‘rebooted’.
Proper HSCT is available at many overseas locations but, so far, there is only one place in the U.S.: Chicago’s Northwestern University, where Dr. Richard Burt has led trials.
Growth in the number of other clinics offering their own forms of stem cell therapies has alarmed many medical professionals and regulators, and this led to the two days of hearings next month. These will help the FDA to decide whether clinics offering stem cell treatments should be more closely regulated.
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