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.

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.

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. 

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.