Welcome or Not, FDA Focuses on Stem Cell Treatments

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FDA public hearing

What's Important Now

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.

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today, or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis.


Philip Longford avatar

Philip Longford

From what I have been able to work out from this, HSCT looks like it can work, and the level of chemo involved is being fine tuned, to reduce the associated risks. BUT simple Stem Cell Treatment is the age old con trick, taking vast sums from ill people, in the unproven hope that it MAY help. Read the small print!!! Sure, we all want a cure, NOW, but do not get conned. If a treatment works, someone honest, will let us know. I would not touch Stem Cell Therapy, with a bargepole-unless it offered the chemo as well. I will wait a little longer. Good luck with your HSCT treatment, Ian.


Hi Phil, I totally agree with your comments about HSCT but, as you say, chemotherapy is essential. Stem cells by themselves do not affect MS; to say otherwise is misleading at best and a scam at worst - in MY opinion. Thanks for your good wishes.

SammyJo Wilkinson avatar

SammyJo Wilkinson

Thanks for quoting me in your article. Per your comment that "chemotherapy is essential", all I can says is that in my case, it was not. HSCT has been around for 40 years as cancer treatment so it is the logical choice for MS today. Expanded high dose adult stem cells have only been available since 2012, so very little evidence - I am one of the first. It did take repeat doses over 2 years before I hit remission and ongoing improvements, but for progressive MS HSCT can take up to 2 years to take affect too. The method I used, you get immediate symptom relief too.

With HSCT you get a very small dose of your own Mesenchymal Stem Cells (MSCs), because they are not expanded. Celltex is the provider I used, they are the only place in the world offering expanded stem cells, because they have a multi million dollar cGMP lab and cellbank in Houston, and the overseas doctors can't afford this. Celltex has collected data for the last 4 years on patients, soon it will be published, and add to the understanding. With the cost equivalent to HSCT, someday this will be the logical choice, since you can skip the chemo risk. In the meantime, it is great that MS folks are getting better with HSCT too! But let's keep an open mind to the evolving treatment options.
Here is my FDA testimony, and demonstration of my mobility improvements.

Theresa avatar


Mr. Frank's, I saw your article a couple weeks back about pursuing your own stem cell treatment in Russia. How's that going for you? I was invited to be examined by Dr. Burt in Chicago, but insurance denied me last minute, so I'm looking to pursue a less expensive avenue on my own as well. Any pointers?

Krystal avatar


I had the FDA approved (Nov. 2015) treatment of Lemtrada in July '16. It is covered by insurance, whether or not fully depends upon your insurance. Research it thoroughly, it is a time commitment and comes with risks. But I didn't have anything else to do. ????


Hello Theresa, I am going to Moscow on October 9 for four days of tests and assessment to see whether or not I am suitable to have HSCT. If I am, treatment there costs $50,000 (USD), which I will have to find. If you are looking for a cheaper alternative, please remember that it is not stem cells that are the important ingredient. Chemotherapy is essential to suppress the faulty immune system. Stem cells help it to reboot more quicly, that is all; it would reboot without them, just slower. Remember, those that say 'no chemo, no cure' are telling the truth.

Theresa avatar


Thank you for the quick response. I have been contacted by several stem cell peddlers that don't offer the chemo, and I don't want to waste my time with their nonsense. HSCT is the only route I'm willing to take after reviewing the research. Would you happen to have a link to the Moscow site so I can see their application requirements?

Jaffar avatar


Thank you Theresa and Frank
Would you please tell me the cost of dr. Burt program.As I'm planning to contact him.

Please check this URL to have access to all centets that provides HSCT.

Krystal avatar


I spent 3 days and $8,000 not including travel expenses, going to California for a pointless stem cell treatment. It is sad what the desperation of MS will cause one to do. It is beyond deplorable what greed causes.

Andy Kuhn avatar

Andy Kuhn

I have MS diagnosed 6 years ago. A gentelman in our support group went through a stem cell treatment and is cured of MS however the damage is done, but he goes to physical therapy and has gone from walking with 2 canes to 1 cane and plays golf once a week. You can read his story at this link http://www.mult-sclerosis.org/craigsstory.html
He is very open about the procedure and very willing to discuss his procedure. He warns against scams and to be vigilante on checking out
places that claim to do the treatment.

Dimitri avatar


This is unconscionable how medical communities around the world are not working together to get HSCT approved; not only for MS, but for a host of illnesses.
Stem cell trials in Canada were performed more than 10 years ago. And now the FDA is contemplating another 10 year trial so they can classify HSCT as a drug? Meanwhile, Russia and other countries are already offering HSCT.
This really makes me wonder what Big Pharma's role is in all this. Follow the money. When stem cell therapy becomes an approved therapy, pharmaceutical companies will be losing a lot of money. Just look at the ridiculous prices they set for our drug. That's the money they will be losing out on.

Terry Richards avatar

Terry Richards

I found your website through a link to the article "FDA may increase regulation of clinics offering stem cell therapies" that also appeared in the AABB SmartBrief. Regulation could not come too soon. The FDA is always behind the curve and it takes them years to get their act together to make sure that patients receive safe therapies. Even though hematopoietic stem cell therapy (HSCT) has been around since the 1970s, the quality and the potency of the stem cells is never tested, even in academic centers. There is a lot of hype regarding stem cell therapy. Even regulated stem cell therapies, e.g. bone marrow, cord blood, use primitive and inaccurate tests that do not measure the stem cells. Instead, they base everything on false assumptions. The marketing used by so-called "stem cell clinics" is similar to that used by private cord blood banks. Do not be lured by these marketing ploys. Please be careful with yourself and your money. I know stem cell therapy sounds "miraculous", but if the stem cells are not properly characterized before they are used, do not be tempted.


Hi Terry, in themselves stem cells do not stop MS. HSCT with chemotherapy is the only hope at the moment.

Harry Crawford avatar

Harry Crawford

I would agree about the pharmaceutical companies basically controlling the FDA. Ocrelizumab had been tied up now for almost 2 years because of the damage it will do to the pharmaceutical industry. Hsct Stem cell will take God knows how long because it actually works. This will put a big dent in the pharmaceutical companies income as well. Imagine that,who cares about the patients the FDA will back the pharmaceutical companies due to the mighty dollar. Unbelievable that our taxes pay this farce of an organization.

Jana avatar


I have an interesting story. I am an ICU RN and I was diagnosed with MS in 2007. I was hospitalized at Northwestern in Chicago because I live close to the area. I had a very severe case. I was hospitalized for 3 months. I lost all of my senses. My hearing was the last to go.

While at Northwestern, the doctors mentioned doing a stem cell transplant but they were unable to do it because the demyelination was happening very rapidly. The last thing they tried was chemotherapy. I slowly started showing improvement. It was like a miracle. I was discharged to a facility. In reality no one knew what was going to happen to me or if I would ever walk or see again. I slowly regained most of what I had lost. I am not 100% but I have more than I could have ever imagined.

I'm still scared anytime I feel new symptoms. Sometimes I feel as though I suffer from a little ptsd because it was an ordeal.

Back to the article, I know Chemo can kill you. I also know that it can reboot your immune system. Stem cells have the potential to become any cell in your body.

I need more research and evidence that shows me what the dose of chemo is needed and the proper technique to use the stem cells.

My advice would be:

If you get stem cells with chemo, I would have loved it, if I had the chance

If you are in your death bed like I was, then you have nothing to lose with whatever you choose

If want to get stem cells without chemo, proceed at your own risk, I do not recommend it

If you are stable but have symptoms, wait until research done.

There are too many piranhas out there that will do anything to make a buck. I am sort of excited that the FDA will step in do something because it is a mess. Something needs to change and we have to come together to try to correct this problem.


Hi Jana, thanks for sharing your story. While I write for MS News Today, the following are purely my opinions based on much research and investigation. 1. HSCT's non-myleoblative protocol that uses lower dose chemotherapy, which is sufficient to treat MS, is the treatment to choose and is the process most widely used for MS; 2. Risk is low, about 0.5 percent (it is the myeloablative protocol, involving higher doses of chemo drugs, that carries higher risks); 3. Stem cell therapy without chemo won´t stop MS, don´t go there, don't waste your money. Chemo drugs suppress the faulty immune system, the stem cells just help it to recover more quickly; 4. Don´t wait, just because youn are stable does not mean you nervous sustem is not under attack - MS does not really remit, it only appears to do so on the outside while the attacks continue inside. The earlier you get treatment, the better.

Paul A Dye avatar

Paul A Dye

We're basically overrun with entities cashing in on diseases. The national money sucker societies, cancer societies and many more. Pig pharma will use every available avenue for keeping cures away. Imagine what a cure for any disease would do to the extremely profitable business of sick people using pharmaceuticals. Billions of revenue gone. If you think for one minute big money's gonna let that happen you'd better wake up Alice because this isn't wonderland

Chris Lamb avatar

Chris Lamb

Paul Dye I am with you. Bottom line, it is about the almighty dollar. We are customers, not patients.


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