News that the US 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, DC. (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The FDA will consider information it obtains from the public hearing and online submissions in finalizing draft guidance documents.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.
This article was written by me and first appeared at Multiple Sclerosis News Today.
4 thoughts on “Welcome or Not, FDA Focuses on Stem Cell Treatments”
This is exciting. Just keep it moving, please?!!!
I don’t understand why so many other diseases are receiving so much attention and MS is not? It’s time!
It’s ” our” turn!
Why , must I be sometimes bed bound and retired at 29?????
Wake up doctors etc whom are getting paid by prescribing these poisonous medications that don’t truly stop our ms .
I have been studying stem cell treatments for some time and had been about to start fundraising to go to a clinic in Russia for treatment with stem cells, this clinic claimed to have a 86% success rate and they have many videos online showing details and people who are supposedly at various stages of Recovery! this clinic does not use chemotherapy & never have! but a lady on the HSTC website advised me Swissmedica is a con, I did not contact them again, but today they phoned me up I told them what I have been told and said all your videos could be actors, they have given me the phone number of somebody in England Who is apparently recovering after successful treatment at the clinic, of course I realise that when speaking to somebody on the phone they could be anybody and lying 100% any advice would be gratefully received.
I am at the stage where I do not think I will be accepted by any of the recommended hospitals for treatment as I have had Ms since well I don’t know but I was diagnosed in 1999 I had been suffering for some time but the doctors reckoned I was making it up comma anyway as I think I will be turned down for hsct by the recommended hospitals I am desperate for any way to cope with living I have read of a injected and very expensive at (£700 Plus each jab) meditation and also the Swiss medica type stem cell treatment again any advice gratefully accepted
Hi Deborah, the AA Maximov Centre in Moscow, where treatment is headed by Dr Denis Fedorenko, most certainly DOES use chemotherapy and is one of the world’s leading centers providing HSCT for MS. Swissmedica, on the other hand, doesn’t. I am not a doctor, just a journalist who happens to have MS, but my views are clear: The most important part of HSCT is the chemotherapy as that suppresses the faulty immune system. The stem cells just speed the recovery process, a process that would happen anyway, just more slowly.