Stem cell therapy: the good, the bad, & the muddy waters

How can you tell who to trust in the world of stem cell therapy? What information can a patient trust?

Once upon a time about a dozen years ago it seemed a much simpler question.

There were universities and biotech companies doing legit research as well as clinical trials, and there were physicians doing bone marrow transplant type work. Back then on the other side there were just a handful of stem cell clinics, mostly outside the U.S., selling sketchy stuff.

Now in 2021 things are a mess.

You might say it’s a time of stem cell therapy muddy waters. Really muddy.

muddy waters, stem cell research
Car trying to navigate muddy waters. Can the stem cell field and patients do it? Creative Commons image.

Ethically Thorny Stem Cell Therapy at Some Universities

Now not only are there as many as 1,200 stem cell clinics in the U.S., but also in rare (yet possibly growing) cases some universities are pitching pay-for-play offerings of unproven stem cell “treatments”.

Two examples of the latter that come to mind are the now-closed Northwestern University autoimmune disease program and the potentially expanding Duke autism and cerebral palsy efforts. In both cases families and patients are (or were) pitched and injected with unproven stem cells or related materials. Large payments are often required from patients to participate, either in trials or in off-study programs. The off-study practice has to have FDA approval to be compliant. However, it’s not clear to me how closely the FDA monitors such programs including when they are operating under the auspices of expanded access.

In my experience, patients often view these university unproven infusion programs as better than but in the same general universe as the unproven stem cell clinics. Part of the risk here is to the stem cell field as the public gets legit stem cell clinical research mixed up with offerings that are far more in the gray zone.

We’re also seeing patients come to accept the idea of having to pay big money (e.g. sadly $15,000 at Duke for an autistic child to get infusion with unproven cord blood) just to get experimental injections. I believe if anything it should be the opposite in that patients should be given something for participating. In fact, a monetary-neutral approach is probably best.

Clinic Suppliers

Further complicating things, we have a whole slew of stem cell clinic-associated businesses as part of this ecosystem.

These include suppliers who target care providers as customers. The suppliers sell mostly ‘dead’ cellular extracts often made from birth-related tissues like umbilical cord, placenta or amnion. Yet these products are generally sold in such a way as to give the impression they are both living cells and specifically stem cells.

“Stem cell” therapies can be viewed as both dead or alive, depending on who the suppliers are talking too.

They are neither alive nor stem cells in most cases. The suppliers even sometimes tell the physicians or chiropractors what to say to potential customers. Some of that boilerplate is wrong and a lot of it is unethical in my view. If the FDA comes knocking, the suppliers claim the materials are dead extracts or that they only sell them for lab research. These are zombie cell therapies in a sense. Both dead and alive, depending on who’s asking.

The suppliers are a major driving expansion of the unproven stem cell clinic marketplace machinery. They dangle the possibility of annual six and seven-figure sums in front of chiropractors and physicians. The big money only comes to these providers if they will start offering cheap-to-buy, but grossly marked up and medically iffy “stem cells” to their patients.

The suppliers themselves sometimes have no in-depth knowledge of stem cell research or medicine such as from university classes, but they know marketing.

This supplier-driven market reality is part of the reason it’s been encouraging to see the FDA giving suppliers much more attention with oversight actions. Each supplier may represent risk equivalent to many clinics.

I believe the suppliers are making things much riskier for patients. Look at the bunch of patients who got septic due to a Liveyon product. 

“Stem Sells” stem cell therapy marketing.

Promoters of stem cell clinics

Another important element of stem cell clinic industry are promoters that mostly didn’t exist some years back.

These firms generally don’t directly sell stem cells or other biological “stuff” themselves, but they make money by promoting clinics that do.

The clinics pay for such promotion, which can include getting clinics higher rankings in Google searches for the clinic websites. More views equal more customers and in my view more risk to vulnerable people.

Complicating the promoter sphere is the fact that some entities in this space mix the stem cell clinic promotion together with other website content that may be actually useful. It seems that Google has had a tough time consistently telling when this is happening. In my view a prime example of this is the site Bioinformant. There are some interesting interviews and factual useful info there, but it’s too often mixed with stem cell clinic promotion in my view.

I’ve also been concerned about another marketing firm called Boston BioLife.

Good news: advancing real clinical trials in stem cell therapy space

To end on a high note, the good news is that an increasing number of legit, rigorous stem cell clinical trials are moving ahead.

More trials are being developed every day around the world.

This brings real hope, not hype.

A few stem cell therapies have been approved. In the US, umbilical cord blood-based treatments for some blood cancers are approved. These are similar to bone marrow transplants. In other countries, a few other approvals are notable including treatments related to GvHD using remestemcel-L and some elements of Crohn’s disease.

Here at my own university, UC Davis School of Medicine, there are dozens of stem cell-related clinical trials either being developed or underway via the UC Davis Stem Cell Program. I’m not involved in those trials. Still, it’s wonderful to see my fellow professors and their talented teams moving forward on that translational and clinical work.

Thousands of such rigorous trials are in the works or at various stages around the world.

That’s real hope.

7 thoughts on “Stem cell therapy: the good, the bad, & the muddy waters”

  1. It is evident that you do not believe that it is right to charge for participation in clinical trials. How about charging in expanded access cases?

    1. I am generally against charging for participation in expanded access cases. Some expenses like travel seem to be the patient/family’s responsibility, but what I’m talking about is fees for actually getting the experimental “treatment.”

      Requiring payments like Duke does for autistic children to get infusions of unproven cells raises a lot of ethics questions.

      Why should anyone pay at all if what is being injected isn’t proven to help or be 100% safe?

      What if people cannot pay? They are just out of luck?

      Also, by requiring payment you’re driving some people onto GoFundMe where they often have to tell their stories to raise funds, releasing what should be their private health info. We saw this kind of thing with Richard Burt’s autoimmune disease program at NW too. Also, by charging I think there’s a negative psychological thing for the researchers too in that they start to believe what they are doing definitely works before the trial work is even done.

      In Duke’s case there’s also a financial conflict of interest because of their deal with for-profit firm Cryo-Cell. I would argue that Cryo-Cell is likely benefiting financially, even if indirectly, from families having to pay for expanded access to the Duke cord blood infusions. That doesn’t seem kosher to me.

  2. An improvement in the MSC field of translational medicine is the more frequent use of mesenchymal stromal cells for the MSC, no more reference to the use of “stem”, I think that is an improvement.

    I think the MSC use should be expanded, it has been around and the potential for some people to benefit out weighs the lack of “perfect clinical trials with a placebo arm”. There are clinics offering MSC infusions in China, Vietnam, Thailand, Mexico, Panama, Cayman Islands, Columbia, and Orange County CA. Why should someone who is suffering from chronic GVHD be denied this potentially effective treatment. The cost of this type of treatment ranges from 13,000 to 23,000 US dollars, plus the need to travel foreign. Bring it home to legitimate insurance covered alternative treatment, “the right to try”. This is illogical to me to keep staving off the use of MSCs, thus forcing patients to look outside the US for treatment.

    Here are some items I found in my searches with regard to MSC treatments:

    Link to clinical trial description on NCT 01522716
    This is a paper that was the result of a study in Sweden (NCT01522716). The article published in Stem Cell Translational Medicine, title: “Treatment of chronic GvHD with mesenchymal stromal cells induces durable responses: A phase II study” ePub 2020 Jun 23, found on PubMed NCT 01522716
    The results seem to infer the possible benefit of having MSCs treatment for cGVHD.

    Perhaps you could call Emory in Atlanta to see how the results are so far.
    Clinical trial to assay if MSC infusion can reduce dosage of prednisone in BMT/SCT patients on greater than 40mg prednisone daily.
    NCT02359929 contact phone number for physicians: 404-778-1900
    Mr. Johnathan Berman, Clinical Research Coordinator III -BMT Clinical Trials, Emory University – Winship Cancer Institute ph#: 404-778-0676Jonathan Berman, CCRP
    Clinical Research Coordinator III – BMT Clinical Trials
    Emory University – Winship Cancer Institute
    1365 Clifton Rd NE, Suite B4000
    Atlanta, GA 30322
    Phone: 404-778-0676
    Fax: 404-778-8583

    An interesting review article in frontiers in Immunology | Alloimmunity and Transplantation, Title: “Mesenchymal Stromal Cells for Graft Versus Host Disease: Mechanism-Based Biomarkers” 2020

    This article seems to advocate more clinical trials with MSCs
    In the journal: “frontiers in Cell and Developmental Biology”
    Title “Clinical Translation of Mesenchymal Stromal Cell Therapy for Graft Versus Host Disease” 11/21/2019

    Mesoblast Limited, 127 page presentation to the US FDA seeking permission to conduct clinical trials leading up to commercial acceptance of the Mesoblast Limited company product Remestemcel-L (Ryoncil). A proposed treatment for pediatric acute GVHD for those that are unresponsive to steroid therapy.
    August 13 2020 Mesoblast 127 page request to FDA for approval, PDF link:

    Pluristem Therapeutics Inc. based in Haifa, Israel
    Clinical developments, GVHD:
    Clinical Pipeline:

  3. So those that wear the white coat of illusory scientific sagacity are those the dull, ignorant “American plebeian profane” should turn to for truth about whether stem cell therapy is right for them? Is that the implication? That would be laughable if it wasn’t so damn sad.

    The so-called “scientific community” is hardly a paragon of righteousness and virtue. It has a myriad of hidden, potentially unscrupulous interests that make entrusting it with one’s critical health decisions utter madness. No one – lettered or not, elected or not, appointed or not – has the monopoly over truth. Americans are entitled to make their own decisions. They can discern the truth for themselves.

    The “scary stem cells” line is the same vacuous, specious concern that was expressed over marijuana use. Now half the states have legalized it – both medically and recreationally – and it’s not even a topic of discussion anymore. In ten years stem cell therapies of various types will be widely accepted, widely available and covered by medical insurance for all types of medical conditions.

    All will be healed.

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