Stem Cell Clinics Under Critical Scrutiny in US

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Stem cell clinics are proliferating in the U.S., where there are now 570 in operation, according to a paper quoted by the New York Times.

And concerns are being raised that these clinics are often operating and making claims beyond those allowed by the country’s public health regulatory agency, the Food and Drug Administration (FDA).

In an article headlined Stem Cell Therapies Are Still Mostly Theory, Yet Clinics Are Flourishing,” Gina Kolata says the clinics are “offering untested stem cell treatments for just about every medical use imaginable.”

She continued: “In theory, stem cells might be a useful treatment for certain diseases that involve the loss of cells, like Type 1 diabetes, Parkinson’s or osteoarthritis. They are primitive cells that can develop into a range of mature cells and perhaps serve as replacements. But progress is slow. After a flurry of stem cell excitement two decades ago, almost all the research today is still in mice or petri dishes. The very few clinical trials that have begun are still in the earliest phase.

“The problem is that stem cell therapies are still mostly theory. So what is going on? How can there be clinics, even chains of clinics run by companies, offering stem cell treatment for almost any disease you can think of — sports injuries, arthritisautismcerebral palsystrokemuscular dystrophy, ALS, cancer?”

According to the article, the rapid proliferation of stem cell clinics “looks like it is occurring on a nationwide industrial scale,” said Leigh Turner, a bioethicist at the University of Minnesota, who, with Paul S. Knoepfler, a stem cell researcher at the School of Medicine of the University of California, Davis, published the new paper tallying the clinics. “It’s operating brazenly, out in the open. It leaps out of these cultural assumptions about hopes and dreams of stem cell treatment, but there is no science behind it.”

In fact, the FDA allows clinics to inject patients with their own (autologous) stem cells as long as the cells, or the tissue the cells are extracted from, meet specific criteria, including “minimal manipulation,” and are intended to perform their normal basic function.

Some clinics advertise treatments that seem to flout the regulations, offering, for example, stem cells from amniotic fluid, which do not qualify under the FDA’s rules because they are not from the patient’s body.

Others advertise stem cells collected from a person’s blood or fat to treat a neurological disease like Parkinson’s or multiple sclerosis. Those cells do not qualify because they do not normally function in the brain to control movement. There is no registry of patients going to these clinics, so it is unclear how many have been treated.

There, I must question the argument of the critics of such treatment – not just for MS, but for autoimmune diseases generally.

Plenty of evidence exists, both in clinical trials1 and anecdotally2, that the stem cell treatment — popularly known as HSCT — does, indeed, work. However, that transplant therapy requires the use of chemotherapy and, as far as I can see, The New York Times fails to mention that, possibly because these new clinics are not offering it.

Using everything that I have learned about the use of stem cell transplants to treat MS, I have absolutely no hesitation in saying that the best one is Autologous Hematopoietic Stem Cell Transplantation that includes chemotherapy.

I believe that, as far as MS is concerned, any stem cell treatment without chemotherapy is worthless.



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. 


Fiona avatar


I'm simply saying this is just disheartening to all of us who have been halted..

Doug J Glener avatar

Doug J Glener

NYU has successfully conducted stem cell transplants without chemo for people with MS, and has achieved remarkable results in a phase one trial. It is partnering with Cornell in a phase 2 trial in 2017.

Veritas avatar


It is sad that there is not clear enough communication to both physicians and the public about autologous non-ablative HSCT. No chemo no cure. Ablative HSCT is good for those who are struggling with very fast moving malignant MS, and are younger. The non-ablative is milder and takes less time to recover from. It puts MS into remission around 90% (or better). When the bone marrow is ablated (destroyed) it makes for a longer recovery time and may cause side effects such as osteoporosis in older age. Autologous means the patient uses their own bone marrow stem cells thus no later side effects due to system rejecting foreign cells. There are a lot of fly by night stem cell treatments. Some stem cell treatments are good, however, unless chemo is performed, the body's immune system will continue with the B cell, T cell and antigens that trigger attacks on the myelin and so any treatment will be eventually undone, unless chemo stops the immune system from attacking the myelin. Non ablative, and even ablative HSCT, has a lower mortality rate than many of the immune suppressant drugs already okayed and on the market. However because there has been so small trials in North America for ablative MS, it is likely not the treatment itself that makes it the riskiest, but the lack of fine tuning the chemo treatment itself. That can only be improved by treating more patients. Cancer centres have treated thousands of people and likely know the fine tuning for this type of procedure. Remember that the chemo treatment for autoimmune disease like Multiple Sclerosis is chemical, with no radiation, similar to blood cancers, not organ cancers. No radiation makes it less severe than chemo that goes through both radiation and chemo.


Well said, I think your opinions are right on the mark.

Philip Longford avatar

Philip Longford

I was watching this lady on the video, rabbiting on very fluently, using lots of big words that I have never heard, or could pronounce. BUT, all the time, I was thinking, I could imagine anyone, with a disease like MS, and desperately clutching at straws, could be fooled!! It reminds me of the 'Doctors' in the Wild West, with their magic elixir, and someone (obviously their 'plant') is suddenly, miraculously 'cured'. So everyone buys a bottle of the Tonic. I am no expert, but I would like to have one look at her sales pitch! As Ian has said, time and again, if the stem cell treatment does not come with Chemo, it will Do Nothing. It is a con! HSCT (Look for the H!!!) really does look like is has some hope, at halting, or even reversing the MS. None of us want to kill the hope of similarly affected people, but keep an eye on sites like this, and DO NOT GET TAKEN FOR A RIDE.


Hi Philip, I could not have said that better myself. I am not a doctor nor a scientist but I do have MS and, as a journalist, have listened intently, read a great deal and researched stem cell therapy for MS. The thing is, it really isn't stem cells that are important. The key part is chemotherapy to suppress the faulty immune system. The immune system would rebuild healthily without stems cells, they just speed up the recovery or 'rebooting' process. I agree with everyone who, when talking about stem cell therapy for MS, says NO CHEMO, NO CURE. Is HSCT a cure? Hand on heart, I don't know but, from what I do know, it is getting better and longer lasting results than anything else. I am so convinced that I want to have HSCT and am due to travel to Moscow in three weeks for a clinical assessment to make sure other medical conditions don't prevent me from having it.


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