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The Bottom of the Stem Cell Barrel

In case anyone was wondering, the commercial stem cell clinic business is still shady and full of hype, profiteering, and outright fraud. Overflowing with all of those, actually. And although there are people turning profits on this stuff all over the country, it may not surprise to learn that there’s an awful lot of it out in Utah, which has long been a center for the “nutritional supplement” business and is now branching out.

It’s not hard to find people advertising stem cell treatments for a whole list of ailments. If you’d like to see some, just type “stem cell therapy” into Google and watch the paid ads that show up next to your search results. These people will talk up everything from joint pain all the way to Alzheimer’s. From those two indications, you’d be correct in assuming that many of these operators are targeting elderly customers with the promise of some sort of regenerative therapy, injecting them with young, fresh, healthy cells that can turn into new cartilage, new heart tissue, new neurons and whatever you like. Well, that would certainly be great. But that’s not what we have right now (despite a great deal of real research and its accompanying time, effort, and money). Figuring out the right sorts of cells to use, how to collect them (and from where), how to administer them (and to whom), and how to make them do what you want them to do once given to a patient – these turn out to be extremely hard problems.

They were extremely hard problems fifteen or twenty years ago, when the general public first started hearing a lot about stem cells, and they still are. (I well recall John Edwards as a vice presidential candidate, telling people about how folks were going to be getting up out of wheelchairs, etc.) And there are so many issues that we haven’t worked out yet – just to pick one, think about what might happen if you administer some vigorous young cells that are capable of turning into various types of tissue and growing. . .hmmm. . .exactly. Here’s a case of a tumor resulting from an experimental stem cell therapy attempt, and it’s a real concern.

The thing is, there really are a lot of legitimate opportunities in stem cell therapy, and there’s a lot of legitimate effort going into trying to get them to work. “Regenerative medicine” is a real topic and very much worth investigating. But the folks in the strip-storefront clinics with the toll-free numbers and all major credit cards accepted, they’re not helping to do any of that work. But if you’re a desperate customer without any sort of medical or scientific background, what you’ll see are all those clinics, and they talk about the thousands of people that they’ve helped, and they have locations around the country (around the world!), and about their cutting-edge science, the latest research, all those clinical trials (!), and the case histories are just amazing. . .and you’re trying to tell me that none of this is real? That it’s all just some sort of scam? Why, yes. That’s the right word.

Here’s a report from earlier this summer at the New Yorker with ProPublica, which details how things are done at the Utah Cord Bank. It’ll show you just how this business works:

“Patients come back to the center saying, ‘I can walk farther, I can breathe easier, I can sleep better,’ ” (Dr. Greene) proclaimed. “It’s remarkable, the outcomes we’ve been seeing for the last few years.” In the second row, a slender woman in a striped jacket, who had hobbled into the meeting on a wooden cane, pumped her fists in the air. “Stem cells!” she cheered.

Yeah. If you read through the article, you’ll discover that “Dr.” Greene’s title is strictly honorific. He used to be a surgeon until a blizzard of malpractice lawsuits let to his medical license being revoked, but he’s not letting that slow him down one bit. One of the keys to the business model is that these alleged stem cells are extracted from cord blood donations around the country (as opposed to another branch of the “business” that extracts them from liposuction samples). As the article shows, most women signing the form are under the impression that they’re helping medical research, rather than enabling a bunch of hucksters to buy vacation homes. For the most part, no one really assays these cell preparations much, and there’s evidence that whatever stem cells are present are dying. But who cares? There’s no real evidence that the “therapies” being administered with them do anything at all, other than generating bills that no medical insurance will cover. The FDA has done a terrible job at regulating this industry, and has let so many cats escape out of so many bags that I don’t see how they’re going to get a handle on things. They’ve been making more moves in the area, but I wish they’d try even harder. So we have this:

. . .the staff told her that the supplier was offering a discount that would lower her cost to seventy-three hundred dollars, for injections in both knees. “They were just acting so shocked, one of them said, ‘I’ve never seen a discount this high before,’ ” she recalled. “I was so gullible.” She received an injection in each knee, and returned every two months for a checkup. “They had me fill out this form every time to record my pain level, and it was close to ten every time,” she said. The staff assured her that she would improve within six months, but her knees did not get better.

Here’s an article from a firm of short-sellers, the evocatively named Hindenberg Research, on another Utah-based stem cell operation called Predictive Technology. Some of their employees seem to have come over from the firm described in the New Yorker article, actually, and one of their directors is our old friend, former Utah Senator Orrin Hatch. He should rethink that appointment, because while the article is of course a brief for the prosecution, the Hindenberg folks make a compelling case for the entire Predictive operation being yet another scam. Higher-ups all over the company (including the CEO) have records of securities fraud accusations and many have SEC enforcement histories. Four of the company’s recent “acquisitions” have exactly the same address, which used to be their own. And so on. In general, the company relies on exactly the same sorts of deception at the front and back end of its business as the Utah Cord Bank and many others – women think that they’re donating tissue for research, and patients think they’re getting an effective therapy with evidence behind it. Neither are true.

There are all sorts of problems. Stat has reported on companies actually requiring employees to give some stem cell clinics business, because their “therapies” are cheaper for the employer’s health insurance than (say) a knee replacement. Companies are not only selling unproven treatments to patients, they’re raising money and selling stock to investors who want to get in on what looks like a hot business. This whole area is a blot on the medical landscape; these people stripping money from the pockets of everyone within range. In return they do no good whatsoever, and often do actual harm (here are some recent cases of stem cell injections that had a bonus of bacterial contamination, which is not the sort of thing you want injected into your sore shoulder). In return, actual scientists in the field (academic and industrial) are getting splattered with the all the mud. It’s a shame. It’s a disgrace. It shouldn’t be this way.

 

 

48 comments on “The Bottom of the Stem Cell Barrel”

  1. Louis Coury says:

    It’s one thing when fly-by-night companies sell the placebo effect via ground up twigs and bark in solid oral presentations. Injecting human cells (alive or dead) into patients is quite another thing. It is just a matter of time until another New England Compounding Center fiasco surfaces. Since Senator Hatch fancies himself as an erstwhile healthcare regulator, he needs to be called on to testify at the inevitable congressional hearing that will result after a patients die. He clearly has skin in the game now….

  2. Thoryke says:

    I expect there are a few bits of questionable science over at Regen America, too. A rep tried to inspire me to attend his lecture with the phrase “And it’s all FDA-approved, of course!” Color me skeptical…

  3. Jake O says:

    Hindenberg Research? That seems almost too on-the-nose, don’t it?

  4. Anon says:

    Stem cell treatment is the modern day version of what wild West offered, then! When it comes to the questionable science the retired Utah senator is the modern day version of Al Swearengen.

  5. BernYeeStemCells says:

    Don’t just pick on Utah- Massachusetts has stem cell clinics all over the place too. Its a scamdemic nationwide.

    Ow, my Joints!

  6. Dr. Manhattan says:

    Hindenberg Research? That seems almost too on-the-nose, don’t it?
    “Oh, the humanity!”

    1. Down the slipway says:

      Here’s to the launch of the sister companies Titanic Therapeutics, Lusitania Life Sciences and Bermuda Triangle Biopharmaceutics…

    2. RandomWok says:

      They’re short-sellers, so the name is appropriate. They make money from puncturing inflated claims made by fly-by-night companies – Orrin other words the nefarious fraudulent “schemes” that they Hatch!

  7. ENES says:

    I was visiting a friend in NJ (he has RA) and at his request, accompanied him to an appointment with a stem cell specialist. When I saw more pics of the doc with celebrities instead of medical credentials, I should have probably dragged my friend out. However, since they already had his payment card info, figured meeting the doc was worth the time. It was a surreal experience to say the least (doc claimed he has done clinical trials, his products are approved etc etc). On my way out, I was surprised to see folks getting IV drips and realized this ‘doc’ has probably cracked the code. His biz model – stem cell for click bait but never offers it. There are about 10 steps of ‘evaluation’ and ‘treatments’ before he can offer stem cells and he has made is $$ well before the patient gives up. Pretty neat, eh?

  8. DirtBikeRider1943 says:

    It is disappointing to see Mr. Lowe, a PHD, presumably with some research in his background, conflate a spurious relationship between Utah being a hotbed of dubious nutritional supplement marketing and the presence of stem cell laboratories in the state.

    The University of Utah is one of the most respected medical research universities in the U.S. and has particular expertise in stem cell research and development that goes back to the 1970s. It should be no surprise to Mr. Lowe that such companies would develop close to the research that begat them—and that they could be independent of nutritional supplements, incredible skiing, the Mormon Tabernacle Choir, or any other cultural or geographic feature of the state.

    The Hindenberg Report about Predictive Technology primarily contains accusations of financial and securities-related malfeasance, but also highlighted that some of its salespeople and distributors were making unsubstantiated and outlandish claims. If the information in that report is true, the company will likely very soon be facing scrutiny from the SEC, the FDA and the FTC. The FDA is very active about sending reprimands to stem cell distributors who make claims outside of the FDA-approved scope of treatment (there are several approved treatments).

    Utah Cord Bank, on the other hand, is a scientific laboratory that produces stem cells under the watchful eye of the FDA. They have never been cited by the FDA for unwarranted claims because they don’t make claims. Dr. Greene from the ProPublica article chooses to sell Utah Cord Bank stem cells—although he could choose to sell stem cells from any other laboratory. It seems like it is made very clear in the ProPublica article that Dr. Greene does not work for Utah Cord Bank.

    1. Derek Lowe says:

      I said nothing about the University of Utah in the post. But if you read the New Yorker/ProPublica article, the Utah Cord Bank does not come across very well. And I only wish that the FDA, FTC, and SEC policed this area as well as you seem to believe they do. We wouldn’t have hundreds of stem cell clinics across the country, and we wouldn’t have Dr. Greenes up on stage touting their benefits.

      1. DirtBikeRider1943 says:

        Thanks for your response Mr. Lowe. The relevance of the University of Utah is that private laboratories that produce stem cells would naturally tend to spring up near university facilities that specialize in stem cell R&D–and the University of Utah is one of the top facilities. Leading your readers to make the inference that stem cells are the logical next iteration of nutraceutical puffery simply because both industries share the same state is not good correlation.

    2. matt says:

      DirtBikeRider1943, would you like to disclose your relationship with Utah Cord Bank? Is your last name Spencer or Kimball?

      If it is a scientific laboratory, can you point to any published research article concerning work done there? Or did you mean “scientific” as in people wear white coats and there’s a centrifuge, some pipettes, and a hope that bacterial contamination does not occur? Can you point to any stem cell research that used the Utah Cord Bank’s stem cell product, as sold to customers, to obtain a viable set of stem cells? Is the Utah Cord Bank also a low-profit limited liability company under the state of Utah?

      1. DirtBikeRider1943 says:

        Hi, Matt. I’m glad you asked.

        Yes. No. Yes. Yes. Yes/Yes/Yes/No. Yes. No.

        My name is Clint Okerlund and I work for Utah Cord Bank.

        When I say “scientific” I do, in fact, mean that we have numerous lab coats, several centrifuges, a large array of pipettes in various sizes and a whole bunch of other more impressive laboratory equipment you didn’t ask about. But I also mean that our Chief Science Officer and Founder has a PhD in biochemistry, two post-doctorate fellowships, and over two decades of experience working with human cells.

        We also have the processes and procedures needed to produce stem cells from amniotic birth material that would otherwise be discarded in the hospital’s waste bins—and we produce those stem cells without bacterial contamination. Then we test for bacterial contamination anyway just to make sure. And then we test it a couple more times. We have produced over 100,000 units over the last 14 years with no serious adverse events and we have a spotless FDA record. We are obsessive about safety.

        We perform our own viability tests with each batch of cells and occasionally have our viability confirmed by third party laboratories.

        Utah Cord Bank is a tax-paying S-Corp and we are careful to educate donating mothers that their donations will be used both for research and for profit. We also donate a significant amount of stem cells to physicians who then use the product specifically to treat veterans, first-responders and veterans for free.

        1. DrOcto says:

          All without any proof that what you’re doing actually works

        2. Desdar says:

          The more read about the Utah Cord Bank the more it smells like a scam front. The UCB isn’t accredited according to any laborartory standart (ISO 17025 or smilar). A registration is not comparable, instilling the idea that you are trying to inspire undue confidence in those that cannot know better.

          The UBC furthermore doesn’t inform its clients how it performs any of the tests, nor to which degree of accuracy or how the it ensures the nessecary quality standart to safeguard the safety of its products.

          Can you as of member of the UCB provide any public documentation proving that the laboratory is able to perform any tests to any international standart?

        3. Me says:

          Yeah dude nearly all of that last post would be replaced with the term ‘ *** certified’ if it was as above-board as you claim it to be. Now for all the prizes, tell me the 3 letters currently being represented by asterisks.

        4. Icefox says:

          You know usually when you are commenting on something you have a potential vested interest in, you disclose that fact *before* someone else calls you out on it.

        5. matt says:

          Clint, perhaps I should make clear I have no objection to any work the Utah Cord Bank, or any other similar organization, performs to provide hematopoietic stem cells to appropriate customers. That product is FDA-approved, there is scientific evidence of safe and effective treatment, and if you produce such a product, good for you.

          But I suspect a much larger fraction of UCB’s business these days is tied up in the stem cell market described in the New Yorker / ProPublica article. The stem cell market that does not care to differentiate what type of stem cell it is referring to, because it would prefer to act like all stem cells are as capable as embryonic stem cells, and then it would prefer to assume that every possible benefit which might be conceived for a stem cell is actually true and scientifically proven. To the extent that Utah Cord Bank is supplying this business for cynical profiteering reasons, I hope the FDA sends you a nice little letter.

          I don’t particularly care if you are providing (likely chiropractic) doctors with material with which to scam veterans and first-responders. That just makes it worse that you are trying to use veterans and first-responders to scrub your reputation, while facilitating others taking advantage of them.

          You say “We perform our own viability tests with each batch of cells and occasionally have our viability confirmed by third party laboratories” but each knowledgeable researcher I’ve read has been dubious about the viability of (non-HPSC) stem cells from the products sourced from your facility, or indeed any cord product facility. Not just the viability of cells, but the question of which variety of stem cells are present, and do enough survive to have any reasonable expectation of any stem-cell-derived activity?

          I wonder if a legal team pursuing discovery material went through the Utah Cord Bank’s emails and papers, if they would find any mention of the quantity and types of stem cells that might be found in the various fractions of materials you handle. Any substantiation, for example, that viable stem cells other than HPSCs can in fact be cultured from your products as shipped, and which ones, from which fraction of cord starting materials. You would need such evidence to back up any claims made to customers about the presence of viable stem cells.

  9. Anon says:

    Question is why the US allows this kind of thing to continue?

    1. Frank says:

      Unfortunately US allows many irrational things to continue… FDA needs a stronger spine to regulate pseudoscience…

      1. Isidore says:

        Search “stem cell clinics Europe” and you will find that this is not a US phenomenon only.

      2. Lawrence E Wolfe says:

        D.T.

      3. Lawrence says:

        Chiropractic for example

    2. loupgarous says:

      It’s because we have a somewhat loose regulatory set-up here. It’s better than (as in the Kingdom of the Ants in T.H. White’s The Once and Future King>/i>) “everything which is not forbidden is compulsory”. There are occasional harms from our set-up. but we also benefit from innovation and a more flexible economy, and actual fraud is punished more often than not.

      1. Emjeff says:

        Except that we don’t. Stem cells are an unapproved therapy PERIOD. The FDA is perfectly within its purview to shut these people down at any time. It does not do so because of misplaced priorities, and political cowardice. The law is on their side, and they would prevail in court without question, but they don’t try because they’re afraid of bad press.

  10. Wendell Wilson says:

    Before writing articles or comments about stem cell therapy, it would be helpful to give to:
    scholar.google.com
    and use the search terms
    “stem cells” knees

    1. Patrick says:

      Yes, and then read some of the articles. It’s a very good idea – you should try it. Though perhaps make sure they’re from reputable journals first. Oh, oops – I assume those aren’t the articles you want me to read.

  11. cancer_man says:

    “But that’s not what we have right now…”

    There was a study at Stanford in 2016 that showed someone was able to get out of a wheelchair after stem cells were inserted into his brain. A woman in the trial, who had a stroke in her 30s, was able to speak better and had much greater mobility with her arms. 120 more people are now enrolled in a larger trial at Stanford.

    Chuck Murry at the U of Washington is optimistic that a stem cell trial for heart failure patients that starts next year will go well based on great results in monkeys.

    1. David E. Young, MD says:

      Perhaps the women would have gotten out of the wheelchair with a placebo treatment. There is such a thing as a placebo effect. You say that there is a clinical trial? Well, let’s wait for the trial to be completed, peer reviewed and published.

      1. Dan says:

        LOL, sorry MD, try working on the inside of the pharmaceutical industry for a while, “clinical trial” results are often times meaningless and just plain rigged.
        Most doctors are oblivious to this fact, even worse, they prescribe things cause they like the blonde bimbo with silicone breasts that shows up as a sales rep, or get to go play golf on some trip that is supposedly an information junket.

      2. cancer_man says:

        Here is a quote from an interview with the lead researcher of the Stanford trial, Gary Steinberg:

        “The surprising finding was that patients who had chronic stroke, meaning they were six months to three years out from their stroke, recovered after the cell transplant. Normally, patients recover from their stroke in six months, and after six months there is little improvement. However, in our study the patients as a group improved within one month of the cells being administered and continued to improve at three months. This improvement was sustained at 12 months and it appears the improvement is even being sustained up to two years in the patients we are continuing to follow. This was a big surprise.”

        https://www.researchgate.net/blog/post/stanford-medical-trial-found-stem-cells-injected-into-the-brain-aid-stroke-recovery

  12. basejumperq says:

    I’m aware of the numerous retractions relating to stem cell use in the regeneration of cardiac tissue. Is there a good, current review of where the clinical evidence for stem cell therapy sits? Thanks

  13. Dan says:

    Had someone try to get me to make peptides last year that supposedly aided stem cell therapy.
    Can’t say it’s any more ridiculous that a lot of the so called “legitimate” pump and dump circuses I’ve been a part of over the years in publicly traded companies.

    Waaayyyy to much lying and fraud in this industry. The overall negative perception of the pharmaceutical industry by the public is well deserved.

  14. loupgarous says:

    Of course, the ur-scam was fetal stem cell research, which by now was going to give us all the things the Utah people are promising. A little historical perspective shows that the press actually collaborated in hyping fetal cell line research, which laid the foundation of credulity for the new snake oil being peddled in Utah. But ProPublica and the New Yorker weren’t as critical of claims for efficacy when we were being pressured to remove bans on fetal cell line research, and perhaps they ought to have been. But the press created a credulous public with a real belief that stem cells are magic.

    And if we go back through Google and the Wayback Machine, we can see that the “gotta do something now, can’t wait, can’t discuss this!” model of discourse is being used again, to foreclose debate on the certain doom about to befall us from global warming. It’s resulted in a nasty character assassination campaign directed at Freeman Dyson (who’s actually done a bit of climatology himself while calculating likely aftermaths of thermonuclear war) because he looks at the hoopla over global warming and doesn’t buy the urgency. Because we can’t question that, either, until some Republican finds a way to make a fast buck out of it.

    Senator John Cornyn is now a believer in global warming and the need to cover Texas and the rest of the world in windmills and solar arrays. Why? Because they absolutely NEED natural gas-fired power plants to meet load requirements when it’s dark, the wind is slack, or when load exceeds the ability of renewables to run cities and industry.

    1. Hap says:

      I think they (most liberals/Democrats) had other political reasons to support fetal cell research, and they ought not have promised what they didn’t know they could deliver, but I don’t think they intentionally misled people about what stem cells might have been able to do. If we knew what it was stem cells could do, it wouldn’t be research, after all.

      There is an awful lot of bottom of the barrel to this, though.

      1. Isidore says:

        Just like with sequencing the human genome so with fetal stem cell research. In order to persuade a skeptical public and reluctant politicians to spend a lot of money or to approve research that many found (rightly or wrong is not germane to this discussion) morally questionable the benefits of such endeavors were overhyped by advocates (politicians, scientists, the media) and by the beneficiaries, whether financial (scientists) or otherwise (patients and families). All this manure that has been spread liberally far and wide made the ground quite fertile for the stem cell clinics.

      2. loupgarous says:

        Hap, I don’t blame the people working with fetal stem cell lines much. They went to their friends in Congress and the press, who knew what would stir public support – pathos over kids with orphan diseases and cancer victims who could only be cured if work with fetal stem cell lines was not only Federally funded, but pushed hard. It’s the kind of thing researchers, once someone else does it on their behalf, can’t walk back very easily. I get that.

        I am not a stem cell skeptic. One of my cousins, a childhood friend with NHL, has been able to live considerably longer owing to a combination of stem cell and bone marrow transplantation therapy. But she sure didn’t get it at a strip mall clinic in Utah, but in a boring old hospital. I’m grateful for the technology, and even willing to concede there’s a place for fetal stem cell line research. I just resent the hype surrounding it, because it then creates a mindset the Utah stem cell hucksters take advantage of.

        1. Hap says:

          It’s still wrong and dishonest – it’s just (somewhat) less evil.

          It seems like a problem with investment that is either long-term or expensive or both that it requires promises that can’t be kept. If you have to promise too much, pretty soon no one believes you, and that makes it hard to do anything useful. That road to hell thing comes up again.

          1. anon2day says:

            “If you have to promise too much, pretty soon no one believes you, and that makes it hard to do anything useful.”…………………I think you just described Wall Street and the US Federal Govt. succinctly in one sentence. Well done.

          2. Isidore says:

            This is the reverse of the boy who cried wolf, and equally effective in shutting people off. Maybe the boy who cried unicorn?

  15. Thanks, Derek, for this useful post. I’m doing some reading up on all the goings on in Utah on the stem cell clinic & supplier front for a new post on my site The Niche. In addition to being a stem cell researcher, I’ve been the main critic of the stem cell clinics for almost a decade. The FDA is stepping things up with 2 lawsuits (one it just won), but it really needs to do more too including on the perinatal front as things are totally out of control there. It’s worth mentioning that one perinatal “stem cell” supplier source got contaminated with E coli and other pathogens, recently sending 12 people to the hospital: https://ipscell.com/2019/05/dissecting-liveyon-fda-inspection-report-perinatal-stem-cell-industry/. It’s lucky no one died.
    Another thing for context is that it’s not even clear if there are (A) living cells and (B) actual stem cells in many of these products.

  16. XXTT says:

    Well, you know, the FDA is busy with the vaping crisis. You can’t expect them to actually enforce the law on unapproved therapies when there are smokers to harass.

  17. Bruce Grant says:

    Fun Fact: Utah became the epicenter of the “nutritional supplement” industry thanks to the Mormon prohibition against caffeine. Early Mormon settlers, denied coffee or tea, discovered that they could brew a satisfactorily stimulating “Mormon Tea” from the Ephedra funerea shrubs that grew in abundance in the Utah territory. Ephedrine-based weight-loss products and “metabolism boosters” were the real money-makers in “nutritional supplements” until outlawed by the FDA.

  18. Well, Ask about stem cell research to those who are living a better life now because stem cell therapies have completely changed their lives.

    1. L. Ron Madoff says:

      You came to the wrong website you God damned quack. Offering people hope without real medicine ought to carry the death penalty.

  19. R3 Stem Cell says:

    Everyone has their own answers when you ask about stem cell therapies, individuals who have used these treatments, have seen what a difference regenerative medicine can make and who just read news and posts online, will say it bad. There is no doubt, stem cell treatments delivered tremendous results for knee and arthritis problems and even have saved individuals from surgeries.

    1. Eugene says:

      “Disclaimer and Cookie Notice: R3 is not promising a particular outcome or making ANY claims. The FDA considers stem cell therapy experimental. Results vary.” From the R3 Stem Cell site. So no better than Homeopathy, nutritional supplements, accupuncture and the rest. How many have taken the treatment (and paid thousands) that it has not helped (or even harmed). Clinical trials answer these questions. Marketing is not Science.

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