The dangers of stem cell tourism

It’s been over three weeks now since hockey legend Gordie Howe died at the age of 88. Detroit, as I’ve pointed out elsewhere, is a serious hockey town, as hockey-crazy as any town in Canada (just look at the fancy new hockey arena being built downtown only a mile from where I work), and it worshiped Gordie Howe for as long as I can remember growing up here.

The reason I mentioned this is because in late 2014, Howe suffered a series of debilitating strokes that brought him close to death. He survived, but with major neurologic deficits. As a result of Gordie Howe’s fame, representatives of a company known as Stemedica who were also fans of Gordie Howe and whose company is developing stem cell treatments for a variety of illnesses, approached the family and persuaded them to take Gordie Howe to the Novastem Clinic in Tijuana, a clinic that to me appeared to exist mainly as a means for patients not eligible for Stemedica’s clinical trials in the US to receive Stemedica’s stem cells outside of a clinical trial, cash on the barrelhead, no questions asked. In a rather ethically dubious move that could only be viewed as paying for publicity (which it got in abundance), Stemedica administered its stem cells to Gordie Howe for free. If you’re not Gordie Howe, however, it’ll cost you about $32,000.

As is the case for most anecdotes like this, Gordie Howe did improve. That is not surprising, because, as Steve Novella, who is a neurologist and thus takes care of stroke patients as part of his practice, told me at the time, the natural history of stroke is neurologic recovery that eventually plateaus several months after the stroke. This occurs as the inflammation from the initial stroke abates and as much regeneration as the body can muster occurs. Also, as was noted before, Howe had a hemorrhagic stroke, which is more dangerous and likely to kill early but, if the victim survives, he is more likely to experience better functional recovery than in the case of the much more common ischemic stroke, in which a blood clot clogs a blood vessel, resulting in the death of brain tissue supplied by that vessel. In any case, as I described, it’s impossible to know whether the stem cell infusion that Howe underwent had anything whatsoever with his partial recovery that allowed him to make a few public appearances in 2015 and 2016.

Unfortunately, the offer by Dr. Maynard Howe (CEO) and Dave McGuigan (VP) of Stemedica Cell Technologies to treat Gordie Howe at Novastem worked brilliantly. Gordie Howe quickly became the poster child for dubious stem cell therapies. Local and national news aired credulous, feel-good human interest stories about his seemingly miraculous recovery, while Keith Olbermann practically served as a pitch man for Stemedica and didn’t take kindly at all to any criticism of his—shall we say?—enthusiastic coverage. The predominant angle taken in stories about Gordie Howe was he had undergone Stemedica’s stem cell therapy and, as result, enjoyed a “miraculous recovery” from his stroke. The vast majority of news coverage also tended to present the magic of stem cell therapies credulously, as all benefit and no risk, as a qualitative analysis published last year clearly showed, finding that the “efficacy of stem cell treatments is often assumed in news coverage and readers’ comments” and that media coverage “that presents uncritical perspectives on unproven stem cell therapies may create patient expectations, may have an affect [sic] on policy discussions, and help to feed the marketing of unproven therapies.”

No kidding.

Why, you might ask, am I reminding you of Gordie Howe’s use of stem cells to treat his strokes? Simple, it became part of a marketing blitz, credulously swallowed whole by Keith Olbermann and many reporters (especially sports reporters, who love any story that can be spun as a great sports hero overcoming all odds), for unproven stem cell therapies. These therapies have been portrayed as very promising (which is likely true, although that promise hasn’t yet been proven or realized) and harmless, which is definitely not true, as evidenced by the story of Jim Gass, as published a couple of weeks ago in The New England Journal of Medicine, The New York Times, The Boston Globe, and a variety of other media. Before I discuss Mr. Gass in more detail, however, let’s recap a bit about stem cells.

Stem cell therapy: Hype and hope versus science

Stem cells are, as I have discussed before, moving from cutting edge science to applied science. The problem, of course, is that with few exceptions they have not yet been translated into safe and effective treatments. Enter the quacks, who make magical claims for stem cells every bit as implausible as any claim made for reiki or homeopathy.

There are two types of stem cells, embryonic stem cells and adult stem cells. The first (and potentially most useful for the widest variety of conditions) are pluripotent, which means that, given the right signals, they are able to differentiate into all derivatives of the three primary germ layers in the embryo: ectoderm, endoderm and mesoderm. In other words, they are able to become virtually any kind of cell. You can easily see why embryonic stem cells are attractive as a treatment: In theory, they could be used to replace or repair any organ or tissue, if only they can be targeted to where they are needed and the correct signals are deduced to induce them to differentiate into the needed cell type(s). Unfortunately, these are enormous challenges. That’s even ignoring the religious objections to the use of these cells, whose isolation requires the destruction of embryos.

The second kind of stem cell is known as adult stem cells. Adult stem cells are undifferentiated cells that remain in children and adults and can proliferate to replenish dying cells and regenerate damaged tissues. They are also known as somatic stem cells. Their defining properties include, as for embryonic stem cells, self-renewal (the ability to divide indefinitely while remaining undifferentiated) and multipotency, the ability to differentiate into several, but not all, cell types. In contrast to embryonic stem cells, though, adult stem cells are limited in the types of cells into which they can regenerate. For example, there are hematopoietic stem cells, which can give rise to all the types of blood cells: red blood cells, B lymphocytes, T lymphocytes, natural killer cells, neutrophils, basophils, eosinophils, monocytes, and macrophages; mesenchymal stem cells, which can give rise to a variety of cell types: bone cells (osteoblasts and osteocytes), cartilage cells (chondrocytes), fat cells (adipocytes), and stromal cells that support blood formation; and neural stem cells, which are found in the brain and can produce the brain’s three major cell types: nerve cells (neurons) and two categories of non-neuronal cells—astrocytes and oligodendrocytes.

Finally, there is a cell type known as an induced pluripotent stem cell (iPSC), which are adult stem cells that have been genetically manipulated to express genes and factors important for maintaining the defining properties of embryonic stem cells, but it is not yet known whether these cells can be used as embryonic stem cells and their uses now, for the most part, consist of in vitro studies and show potential usefulness in transplantation medicine. One problem with iPSCs is that viral vectors are needed to introduce the genes that “dedifferentiate” the adult stem cells, making their use in humans as yet problematic.

When it comes to translating what we know thus far about the basic science of stem cells, here remain many problems to be overcome, such as how to target the cells, how to induce them to differentiate properly, and how to prevent them from becoming cancers, this last problem being the crux of the story of Jim Gass. Thus far, in general, most attempted clinical uses of stem cells involve the isolation of these cells from either the bone marrow or blood (or sometimes from adipose tissue). My basic opinion is that, outside of hematopoietic malignancies, for which bone marrow ablation and stem cell transplantation have been a standard of care for many years, most adult stem cell applications are not ready for prime time yet and should not be administered outside of the context of an IRB-approved clinical trial (not dubious clinical trials in Mexico, where, as I discussed in the context of the story of Gordie Howe, the standards are so lax).

The story of Jim Gass: What’s the harm?

The NYT story about Jim Gass is entitled “A Cautionary Tale of ‘Stem Cell Tourism’,” and you can see why from the very first passage:

The surgeon gasped when he opened up his patient and saw what was in his spine. It was a huge mass, filling the entire part of the man’s lower spinal column.

“The entire thing was filled with bloody tissue, and as I started to take pieces, it started to bleed,” said Dr. John Chi, the director of Neurosurgical Spine Cancer at Brigham and Women’s Hospital in Boston. “It was stuck to everything around it.”

He added, “I had never seen anything like it.”

Tests showed that the mass was made up of abnormal, primitive cells and that it was growing very aggressively. Then came the real shocker: The cells did not come from Jim Gass. They were someone else’s cells.

Mr. Gass, it turned out, had had stem cell therapy at clinics in Mexico, China and Argentina, paying tens of thousands of dollars each time for injections in a desperate attempt to recover from a stroke he had in 2009. The total cost with travel was close to $300,000.

Like Gordie Howe, Mr. Gass, a former chief legal counsel for Sylvania who lives in San Diego, was a stroke victim. As described in the article, Gass’ problems began on May 10, 2009, when he woke with a terrible headache. He fell to the floor, unable to move. Two years after his stroke, he was able to walk with a leg brace and a cane, as his left arm was useless, and his left leg was weak. He was also a perfect mark for the stem cell clinics: Desperate enough to try almost anything and wealthy enough to be able to afford to spend $300,000 over several years chasing a cure. And where did he turn first?

Uh-oh:

“I began doing research on the internet,” Mr. Gass said. He was particularly struck by the tale of the former football star and professional golfer John Brodie who had a stroke, received stem cell therapy in Russia and returned to playing golf again.

So Mr. Gass contacted a company, Stemedica, that had been involved with the clinic, and learned about a program in Kazakhstan. When Mr. Gass balked at going there, the Russian clinic referred him to a clinic in Mexico. That was the start of his odyssey.

The program in Kazakhstan to which Mr. Gass was referred by Stemedica appears to have been Altaco XXI, which is the distributor for Stemedica products there. Now, you might be suspicious of a stem cell therapy that is administered in Kazakhstan, and you would have reason to be. On its website, Stemedica includes a slide show about Kazakhstan that presents it as very modern, particularly Astana, where one finds the National Research Medical Center (NRMC), which Stemedica advertises on its YouTube channel with a promotional video:

Of course, I don’t know for sure that Mr. Gass was referred to the National Research Medical Center in Astana. Oddly enough, none of the stories about him that I read specifically name any of the clinics where he was referred or treated, other than to state that they were in Kazakhstan, Mexico, China, and Argentina, something I find very frustrating, as I wanted to check out their websites and see what sorts of claims they were making. In fact, in a local story revisiting Gordie Howe’s case in light of Mr. Gass’ complication, it’s explicitly noted that the story “has been updated to remove a reference to where Jim Gass was treated.” Very odd indeed. One wonders if there were legal threats. I only inferred that it was likely that Stemedica referred Gass to the NRMC in Astana based on its relationship and its featuring an NRMC video on its YouTube page. It’s quite possible, albeit from what I can tell unlikely, that it was somewhere else.

Wherever Mr. Gass was referred first, wherever he ended up being treated, this all sounds very familiar, as it’s similar to what Stemedica did with Gordie Howe: If the patient’s not eligible for one of its US clinical trials, refer the patient to an international location to receive its product. In Howe’s case, it was to Clinica Santa Clarita, a Tijuana clinic that uses Stemedica products through a Mexican company called Novastem. In Mr. Gass’ case, it was (very likely) the National Research Medical Center in Kazakhstan. Mr. Gass didn’t want to go to Kazakhstan, however; so the NRMC referred him to a clinic in Mexico, and Mr. Gass’s odyssey began, ultimately encompassing three different countries. I don’t know whether or not it was Clinica Santa Clarita, the same clinic that treated Gordie Howe, where Gass was treated. I perused a bunch of news stories about him and couldn’t find the name of any of the actual clinics where Mr. Gass was treated listed anywhere (which, again, I found very odd). In a way, I suppose it doesn’t matter, although, given my blogging about Gordie Howe, I couldn’t help but note the Stemedica connection to Mr. Gass’ story.

What is, unfortunately, not surprising is that Mr. Gass was snared the same way so many patients are snared, as the NYT described. Also, he didn’t listen to his doctors or his sister-in-law:

Mr. Gass’s doctors and his sister-in-law, Ruth Gass, tried to dissuade him. Ms. Gass called the clinics and demanded evidence that their treatments worked.

Some of the clinics hung up, saying they would not talk to a terrified relative, she said. Websites often had data but it did not hold up to basic analysis, Ms. Gass said, and when the data was published, it appeared in vanity journals. Other clinics simply told her, “People get dramatically better.”

She raged against the clinics, telling them: “You ought to be ashamed for charging $40,000 a shot. You prey on people like my brother-in-law who is desperate for help.”

Then came her kicker: “I said, If what you are saying is true, you should get the Nobel Prize. If not, you ought to go to hell. Shame on you.”

But Mr. Gass was undeterred. He was willing to spend his money and go anywhere. What did he have to lose? The worst that could happen, he thought, is that he would have no improvement.

Unfortunately, Mr. Gass was very much mistaken, even though the efforts of his sister-in-law went much further than the efforts of most concerned relatives go to find out the truth and dissuade their loved one from an unwise course of action came to naught.

So what happened? Let’s take a look at the NEJM letter.

Glioproliferative Lesion of the Spinal Cord as a Complication of “Stem-Cell Tourism”

The news coverage Mr. Gass received was important because it revealed that he was the patient described in a letter to the NEJM. The authors, Dr. Aaron Berkowitz et al from Brigham and Women’s Hospital, note that the patient was not taking any immunosuppressive drugs, an important point because it means that there was no reason to suspect that he was immunosuppressed and therefore more susceptible to tumor formation. They also note that the clinics described what they injected as a combination of “mesenchymal, embryonic, and fetal neural stem cells.” The timing isn’t well described in the letter, but I found out from other sources that after his last injection in Mexico in September 2014, Mr. Gass developed “progressive lower back pain, paraplegia, and urinary incontinence,” which lead to an MRI that showed a “lesion of the thoracic spinal cord and thecal sac.” Berkowitz et al described the lesion thusly:

Neuropathological analysis revealed a densely cellular, highly proliferative, primitive neoplasm with glial differentiation. Short tandem repeat DNA fingerprinting analysis indicated that the mass was predominantly composed of nonhost cells (see the Supplementary Appendix, available with the full text of this letter at NEJM.org). On the basis of histopathological and molecular studies, this glioproliferative lesion appeared to have originated from the intrathecally introduced exogenous stem cells. The lesion had some features that overlapped with malignant gliomas (nuclear atypia, a high proliferation index, glial differentiation, and vascular proliferation) but did not show other features typical of cancer (no cancer-associated genetic aberrations were detected on next-generation sequencing of 309 cancer-associated genes [see the Supplementary Appendix]). Thus, although the lesion may be a considered a neoplasm (i.e., a “new growth”), it could not be assigned to any category of previously described human neoplasm on the basis of the data we gathered.

So this mass consisted of “non-host” cells (i.e., not Mr. Gass’ cells) and was unlike any category of human neoplasm ever described. Given that this tumor, whatever it was, grew very close to where the “stem cells” (or whatever the various clinics injected) had been injected into the spinal canal, and was largely made up of non-host cells, it’s hard not to come to any other conclusion other than that this tumor was a result of the stem cell injections. It’s not the first case described either. As Berkowitz et al note, there have been reports of proliferative tumors as a result of stem cell therapy published in the literature before, one a brain tumor.

That tumor formation can be a complication of stem cell therapies should not be in the least bit surprising. The cells are at the very least, multipotent, and, if embryonic, pluripotent. As such, they share many characteristics with tumor cells, not the least of which is being immortal (capable of dividing indefinitely) and being able to invade normal tissue. Indeed, this is the very complication that legitimate stem cell researchers do what they can to prevent, and the authors of the NEJM letter note that legitimate stem cell researchers “have attempted to reduce the risk of stem-cell–related tumors in clinical trials by means of the measured administration of pluripotent stem cells or by differentiating stem cells in vitro into postmitotic phenotypes before administration,” something that these stem cell tourism clinics are not exactly what I’d call vigilant about doing.

What’s the harm?

There are few areas of biomedical research that have been the subject of such intense press coverage and hype as stem cell therapies. It’s not hard to see why stem cells have so captured the imagination of people all over the developed world. In theory, stem cells show extraordinary promise, with the potential to produce game-changing treatments for a wide array of injuries and ailments through their ability, if we can just find out how to activate it, to repair and replace damaged and malfunctioning tissues and organs. They’re also controversial, especially embryonic stem cells, which run afoul of religious beliefs to the point where conducting such research in the US is difficult. Indeed, Tim Caulfield and Amy McGuire have referred to stem cells as nothing short of a “pop culture phenomenon,” promoted in particular by the examples of famous athletes using stem cell therapies for a variety of ailments:

Over the past few years, a new dimension of science hype has emerged: the well-publicized use of stem cell therapies by high-profile athletes. Starting with the 2011 story of New York Yankee pitcher Bartolo Colon receiving cell therapy for a chronic shoulder injury and gaining momentum with the announcement of Peyton Manning’s neck treatment in Germany, stories of athletes using stem cell treatments as a recovery aid have become common.

Gordie Howe was another example, although he didn’t seek out stem cell treatments for a sports-related injury but rather for a far more serious condition. He was aided and abetted by executives at Stemedica, who, through their admiration for Gordie Howe and very likely a keen eye for ways to garner publicity, invited Howe’s family to receive their stem cell treatment free of charge. While one can’t blame a patient with a serious, currently untreatable condition like a stroke, such as Gordie Howe or Jim Gass, for being desperate enough to try anything, one can blame the companies that make claims not backed by science.

Caulfield and McGuire go on to say:

As noted by numerous scholars, only a few stem cell therapies are currently supported by good scientific data. However, despite this clinical reality, unproven stem cell therapies are being marketed to patients throughout the world. The clinics that offer these services often operate outside of ethical or regulatory oversight and exploit individuals at their most vulnerable by offering unproven treatments for incurable and debilitating diseases.

Ask yourself this: Why are so many of these clinics located in countries like Kazakhstan, China, Mexico, and Argentina? It’s not because the scientific facilities are so much more advanced there. It’s because regulatory oversight protecting patients is lax to nonexistent. For instance, as was discussed in the context of Gordie Howe’s case, in Mexico Novastem and its Clinica Santa Clarita, which is where stem cells are administered, are “federally licensed” to use stem cells as the doctor sees fit. Thus, any clinic that is “federally licensed” can administer stem cells however its doctors wish, regardless of whether they are qualified to administer such treatments or not. As I said at the time, learning this actually opened my eyes greatly as to how a weak regulatory environment in Mexico allows all sorts of dubious stem cell clinics to thrive there. No doubt the same is true in Kazakhstan and other countries with clinics favored by stem cell tourists. That’s not to say that there aren’t for-profit stem cell clinics in the US. There are, thanks to some loopholes in FDA regulations.

You might wonder how athletes are similar to more desperate patients like Jim Gass. Caulfield and McGuire note:

It is well known that professional athletes will do almost anything to keep a competitive edge or speed recovery from an injury. These characteristics make them an ideal market (and, one could argue, a vulnerable market) for unproven treatments such as those promoted by stem cell clinics throughout the world.

Just as professional athletes will do almost anything to maintain a competitive edge or to recover from injury faster, patients with serious medical conditions for which conventional medicine offers little, such as chronic neurologic deficits secondary to stroke or injury (patients with spinal cord injuries are common recipients of dubious stem cell therapies), feel an even more intense form of the same desperation. The difference is that professional athletes are celebrities, and their testimonials have the power to influence such desperate patients to try unproven stem cell therapies. Indeed, it was the story of pro quarterback John Brodie’s recovery from stroke that most influenced Mr. Gass to contact Stemedica, whose cells had been used to treat Brodie. The press, particularly the sports press (as exemplified by Keith Olbermann’s credulity about Gordie Howe’s story), love human interest stories of people surmounting all odds to triumph. With few exceptions, they tend not to look too skeptically at the claims being made for stem cell therapies because that would harsh the buzz of a great human interest story. Indeed, I caught a fair amount of flak for just that when I wrote about Gordie Howe.

Advocates of such therapies often ask, “What’s the harm?” After all, Mr. Gass had a useless arm, a weak leg, and was willing to try anything. Well, how’s he doing now? He’s paralyzed from the neck down, except for his right arm, incontinent, and experiencing severe back pain. Worse, as the NYT story notes, his doctors do not know how to stop his tumor from growing:

But now that the doctors knew what the mass was, they were left with another problem: How could they stop it from growing? If it had been an infection, they could have used antibiotics. If it had been cancer, they could have used drugs to target it. This mass, though, was unique.

They decided to try radiation. It seemed to slow the mass’s growth a bit, maybe even shrink it. But recently, Mr. Gass has had another scan in San Diego, and doctors told him that the mass was growing again.

Asked what he would like others to learn from his experience, Mr. Gass said, “Don’t trust anecdotes.”

His sister-in-law had a different reply: “If something sounds too good to be true, it is.”

Exactly. The same observation that applies to alternative medicine claims applies just as much to claims about cutting edge treatments not backed by science.

Unfortunately, descriptions of stem cells that are too good to be true are the primary means by which dubious stem cell clinics advertise their treatments—that, and testimonials from famous athletes like Gordie Howe and John Brodie. The harm consists of patients paying tens—or even hundreds—of thousands of dollars for unproven treatments unlikely to benefit them, patients like Mr. Gass, and interference with legitimate scientific research and clinical trials to determine if stem cell therapies can work and what they’re useful for.

Unfortunately, when it comes to stem cell clinics and the companies that supply them, all too often it’s money first, science later if at all.

Comments

  1. #1 The Smith of Lie
    July 5, 2016

    So… Correct me if I misunderstood the implications of the tumor description, but stem cell therapy gave mr Gass what is for all intents and purposes cancer, except worse?

  2. #2 Ru
    July 5, 2016

    I had no idea that David Cronenberg was writing documentaries.

  3. #3 Michael Finfer, MD
    Edison, NJ
    July 5, 2016

    The treatments gave him something that looks and behaves like cancer but does not have any of the usual genetic markers of cancer. The tumor is probably doing something that stem cells can do in the absence of the normal physiologic signals they would receive in their natural setting.

    It is not clear how common this complication might be because there is no way to determine how many patients who underwent treatments like this actually got stem cells given the regulatory environment in some of the places where these clinics are located.

    In a way it is worse than cancer because it is not clear how to treat it. He will probably eventually die of the disease or of a complication of quadriplegia.

  4. #4 T.
    July 5, 2016

    It is well known that even in their “natural” and regulated environment embryonic stem cells sometimes do become cancer. They are also incredibly aggressive cells. This is absolutely not a wonder.

    I do think that stem cells will become an important part of medicine… one day. But this is not the way.

    Still, I feel terribly sorry for Mr Gass. In a way, sorrier than I feel for the “usual” cancer patient that are duped into quackery. By the description, what he had was, while certainly very uncomfortable, not life-threatening.
    And now instead…

    *shudders*

  5. #5 Helianthus
    July 5, 2016

    @ The Smith of Lie

    what is for all intents and purposes cancer, except worse?

    As I understood it, yep. A mix of the worse features of infection by a parasitic organism and a cancer.
    Simultaneously, cells which are human, yet a foreign organism, and not-exactly cancerous cells, yet bent on proliferating.

    Actually, could these stem cells really be considered cancerous? I’m afraid that their initial state was mostly being mightily confused, and their unchecked proliferation is just a “natural” response of finding themselves without the usual physiological restraints provided by the other cells of their original owner.

    it could not be assigned to any category of previously described human neoplasm on the basis of the data we gathered.

    I read this as Mr Gass’ health issues being a completely off-the-book pathology. Which is also why this is worse than a “regular” cancer.
    We are in uncharted territory, and it may be some time before we find a treatment for this type of condition.
    Although, now I’m thinking about it, maybe specialists in teratology will find this case somewhat familiar.

    I think the poor guy is also unfortunately a member of a very restricted club: he has become a chimeric organism.

  6. #6 Amethyst
    The Crystal Gem
    July 5, 2016

    This is fascinating in how morbid it is. If the mass is foreign, does that mean it has it’s own unique DNA?

    Is it, essentially another malformed human being?

  7. #7 Daniel Corcos
    July 5, 2016

    Maybe interesting to see if the foreign cells express MHC molecules. Then it could be interesting to use immune checkpoint inhibitors.

  8. #8 LW
    July 5, 2016

    One thing I didn’t understand from the news reports, and still don’t, is why this mass isn’t rejected. He isn’t taking immunosuppressive drugs, so why doesn’t his body regard the alien stem cells as, well, alien and try to kill them? I don’t understand why the body doesn’t regard these stem cells as it would any transplant, and attack them. Of course, maybe it is attacking them, but unsuccessfully.

    Maybe one of the medical commenters can help me understand.

  9. #9 MI Dawn
    July 5, 2016

    @LW: this is only a guess. But since the cells reportedly came from undifferentiated fetal stem cells, and pregnant women have suppressed immune systesms (otherwise, they’d abort every fetus as an foreign organism), the cells may be excreting something that prevents his system from identifying them as foreign and attacking them.

  10. #10 Helianthus
    July 5, 2016

    @ Amethyst

    Yes, it does appear these cells have a different DNA. From the report:

    Short tandem repeat DNA fingerprinting analysis indicated that the mass was predominantly composed of nonhost cells

    That’s why I was talking (maybe improperly) about a chimera – an organism whose cells come from different sources.
    About the “malformed human being”, that may be too extreme. Malformed human tissues is more like it.

    Reading on the intertubes, I learned that I number of stem cells clinics propose the injection of the patient’s own stem cells, isolated from their fat tissues. So in these cases it will be more difficult to figure out if a tumor on the stem cell injection site is due to the injected cells.
    In an article in the Washington post, a scientist working for one of these stem cell clinic has shown up, and the “Big Pharma wants to suppress cures” conspiracies are overflowing…

  11. #11 Helianthus
    July 5, 2016

    @ LW / MI Dawn

    Other guesses:
    – I remember dimly from my immunology courses that our immune system could get acclimated to antigens when the antigens are present in very high concentration. Now imagine the repeated injections of millions of cells.
    – more simply, by purpose or accident, the stem cell donor and the patient are sharing MHC markers.

    Also, I guess it doesn’t help that these foreign cells are not true cancer cells. The usual molecular signals which would attract the immune cells are likely not emitted by stem cells., and the hormonal signals those immune cells would release to trigger a cancerous cell’s apoptosis may not be working as well on stem cells in replication mode.

  12. #12 Amethyst
    The Crystal Gem
    July 5, 2016

    @Helanthus: What is a human being, biologically speaking, but human tissue? But I get your point.

    I hate to,sort of, make, light of the poor man’s situation but I just gave me a killer idea for a horror movie/novel.

  13. #13 Terrie
    July 5, 2016

    @Amythest, I don’t think it could be calling a human being, any more tha an amputated limb would be a human being. Yes, human being are human tissue, but the reverse is not always true. Like a square and a rectangle.

  14. #14 Mrs Grimble
    July 5, 2016

    Is there any indication that Mr Gass is going to sue somebody for medical negligence? I know that, having ignored warnings from his own doctors, he’s highly unlikely to win. But if bringing such an action deters just one quack, it might be worth it.
    And I wish some commentaters here would remember that he’s more than some interesting medical experiment. He’s a guy who’s paying a heavy price for getting taken to the cleaners by a pack of lying con artists.

  15. #15 Eric Lund
    July 5, 2016

    Amethyst@12: It sounds a bit like the premise of Heinlein’s The Puppet Masters. Except that these slugs are of human rather than extraterrestrial origin.

  16. #16 Mark Thorson
    July 5, 2016

    You want to whip up the immune system to attack these non-host cells. Seems like the perfect candidate for TGN1412.

  17. #17 Calli Arcale
    http://fractalwonder.wordpress.com
    July 5, 2016

    Now that’s horrific. And I despair of there ever being any repercussions on the quacks who do this.

    The weird cancer makes me think a little of the contagious cancer that’s currently threatening the Tasmanian devils. It spreads from one devil to another by face biting, and as it currently infects about 80% of the surviving population, it stands a good chance of wiping them out. It’s untreatable and kills the animal in months.

  18. #18 Panacea
    July 5, 2016

    Horrifying situation.

    My instructor in my Advanced Pathophys class asked us to discuss research in stem cell therapies for COPD. When I started my basic research, I immediately found a news report from Faux News on a doctor in Manhattan offering a non FDA approved stem cell treatment for this.

    I took the opportunity to discuss why this was a problem with my peers; fortunately they were receptive to it. I’ll have to pass this new information along to them.

    I wonder why these people can’t be charged with fraud.

  19. #19 Panacea
    July 5, 2016

    @ Terrie #13:

    Or, all poodles are dogs, but not all dogs are poodles.

  20. #20 Eric Lund
    July 5, 2016

    Is there any indication that Mr Gass is going to sue somebody for medical negligence?

    Sue whom, and in what venue?

    There is a reason such clinics are located in places like Mexico, China, Argentina, and Kazakhstan: regulatory arbitrage. Those countries have much looser rules about experimental treatments than the US does. When Orac describes Mexican clinics as “Federally licensed”, he means licensed by the Mexican federal government. (Mexico’s political structure imitates the US in many ways, such as having the national capital in the Distrito Federal and subdividing into states–the country’s full name translates as United States of Mexico.) It’s probably more rigorous than the equivalent procedure in Kazakhstan, but that says more about Kazakhstan than it does about Mexico. China is probably about as strict as Mexico–probably stricter on paper, but some officials may be susceptible to bribes. I have no idea where Argentina falls on this scale, but presumably nowhere near US/EU standards.

  21. #21 capnkrunch
    July 5, 2016

    Eric Lund@20

    Sue whom, and in what venue?

    IANAL, but maybe Stemedica if they referred them outside of the US to bypass FDA regulations.

  22. #22 Terrie
    July 5, 2016

    @Panacea, i now have the urge to put cotton balls on my doberman and call her a poodle. Except she’d just eat the cotton balls.

  23. #23 Dick
    Ann Arbor
    July 5, 2016

    Based on my experience volunteering at a biochemistry lab at the local university, I’m surprised that stem cells were able to proliferate indefinitely like this.

    In the lab, they worked with both cancer and (mouse) embryonic stem cells, and I was told that the embryonic stem cells would differentiate if they are not replated daily (to provide a reagent that prevented differentiation and to prevent the cell density from going too high–that’s enough to cause differentiation by itself). In fact, I was expressedly forbidden from working with ES cells because of how expensive the reagent was ($100 for a small vial).

  24. #24 Michael Finfer, MD
    Edison, NJ
    July 5, 2016

    The medicolegal issues are one of the reasons that stem cell clinics locate in these countries apart from the regulatory issues. If this patient had had his therapy in the US and this happened, he could well take the clinics and the doctors to the cleaners. In some of these other countries, it is not just difficult, but nearly or completely impossible for a patient to win a medical malpractice suit.

    I think, from a legal standpoint, this fellow is out $300,000, he is much worse off than when he started, and he has essentially no recourse.

  25. #25 herr doktor bimler
    July 5, 2016

    Actually, could these stem cells really be considered cancerous? I’m afraid that their initial state was mostly being mightily confused, and their unchecked proliferation is just a “natural” response of finding themselves without the usual physiological restraints provided by the other cells of their original owner.

    Sounds akin to infantile haemangioma (one kind of birthmark), where a group of stem cells in the newborn infant do not get the message that it’s time to stop growing so fast, and there is proliferation and angiogenesis.

    why this mass isn’t rejected

    An immunologically privileged part of the body?
    Part of the scammers’ rationale for injecting foreign cells into the brain or spine is that they will survive, the immune system won’t see them.

  26. #26 herr doktor bimler
    July 5, 2016

    “I began doing research on the internet,” Mr. Gass said.

    Any story that starts like that, there is not going to be a happy ending.

  27. #27 Stuartg
    July 5, 2016

    Amethyst@ #12

    A novel with a similar premise that has received multiple awards is Greg Bear’s Blood Music.

  28. #28 LW
    July 5, 2016

    An immunologically privileged part of the body?
    Part of the scammers’ rationale for injecting foreign cells into the brain or spine is that they will survive, the immune system won’t see them.

    Ugh. That would mean any failure of asepsis could lead to some horrifying infection. Not as bad as the unfortunate Mr. Gass’ situation, but still very bad. I wonder how many people have suffered life-threatening infection from these “stem-cell clinics”.

  29. #29 herr doktor bimler
    July 6, 2016

    I hate to,sort of, make, light of the poor man’s situation but I just gave me a killer idea for a horror movie/novel.

    “Pathologist Dr. Bondo attempts to convince the family of a man dying from liver cancer to donate his liver to the hospital for his research. (In fact, he wants it as a trophy, it being the second largest hepatosarcoma ever recorded.) When his request is denied, Bondo has the cancerous liver transplanted into his own body (the patient having signed an organ donor form), so that the cancer will become his personal property and can be kept within the hospital.”

  30. #30 rs
    July 6, 2016

    ““I began doing research on the internet,” Mr. Gass said.

    Any story that starts like that, there is not going to be a happy ending.”

    That isn’t so bad. Lots of my research starts on the internet. The real problem is when research starts on the internet and also stops there.

  31. #31 Daniel Corcos
    July 6, 2016

    @ HDB
    I began doing research on the internet and I found a Dr. Bondo proposing cell therapy for free, but the contract was quite weird as it included a clause of permanent stay in the hospital.

  32. […] week, I wrote about a man named Jim Gass, a former chief legal counsel for Sylvania, who had suffered a debilitating stroke in 2009 that […]

  33. […] In the case of Jim Gass, a stroke patient who sought stem cell therapy at clinics around the world, the intervention proved to be disastrous, as cells injected into his lower back grew into a cancer-like mass that left him paralyzed from […]

  34. […] takes a lot to make a biologist say eww. I said it a few days ago upon perusing The dangers of stem cell tourism and Stem cell tourism: a problem right here in the good ol’ USA at Respectful Insolence, one […]

  35. […] border from San Diego in Tijuana for easy access by American patients. Sometimes, in the case of dubious stem cell clinics, they are located in countries like China, Argentina, or Kazakhstan. That’s not to say that […]

  36. […] That’s the narrative one frequently hears about stem cells in the press and courtesy of offshore stem cell clinics in places such as Italy and direct-to-consumer marketing of stem cells in the US. Of course, stem cells aren’t mystical and magical, although they are very promising as a treatment for some degenerative conditions. As promising as they are, though, they don’t cure everything. In fact, we don’t even know for sure that they cure anything because for the vast majority of conditions for which stem cells are used in these clinics, they are still at best experimental and at worst completely unproven. In fact, at their worst, they can do great harm. […]

  37. […] my perspective, what Stemedica does, particularly through its international partners, resembles stem cell tourism and for-profit human experimentation far more than it does science. And Stemedica keeps popping up […]

New comments have been temporarily disabled. Please check back soon.