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.
Move to regulate stem cell therapies
Stem cell treatments aren’t approved by the FDA. At the moment, the FDA framework applicable to stem cell therapy and the use of autologous (a person’s own) stem cells is based on the same regulatory process used to approve new chemical-based medicines, vaccines, and biologics. As a result, stem cells transplanted back into the same patient are included in the broader statutory definition of drugs.
The FDA will consider information it obtains from the public hearing and online submissions in finalizing draft guidance documents.
Sammy Jo Wilkinson, founder of a patient group called Patients for Stem Cells, plans to use the hearing to appeal for a faster approval process for stem cell therapies and a registry to monitor patient outcomes.
Of the FDA hearings, she said: “Patients will never get these treatments if they have to go the traditional double-blind placebo-controlled trial route. That takes 10 years and $1 billion. There’s got to be a middle ground, where you don’t shut off treatment, you just keep track of it.”
Paula Grisanti of the National Stem Cell Foundation agreed that stem cell therapies need approval, but warned against those claiming too much. “This is the future of health care,” she said. “But clinics that make over-the-top claims that a single stem cell therapy will cure ALS or Parkinson’s or other diseases raise huge safety and ethical concerns.”
It will be interesting to see whether or not the FDA chooses to regulate autologous stem cells as a drug. If it does, not only will that restrict the activities of those 600 clinics but, potentially, also the possible future development of proper HSCT centers in the country.
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