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Cracking Down on Stem Cell Tourism

The International Society for Stem Cell Research (ISSCR) is a professional organization of stem cell researchers. I am happy to see that they see it as their responsibility to respond to the growth of dubious stem cell clinics offering unproven treatments to desperate patients.

In a recently published handbook for patients, they write:

The International Society for Stem Cell Research (ISSCR) is very concerned that stem cell therapies are being sold around the world before they have been proven safe and effective.
Stem cell therapies are nearly all new and experimental. In these early stages, they may not work, and there may be downsides. Make sure you understand what to look out for before considering a stem cell therapy.
Remember, most medical discoveries are based on years of research performed at universities and companies. There is a long process that shows first in laboratory studies and then in clinical research that something is safe and will work. Like a new drug, stem cell therapies must be assessed and meet certain standards before receiving approval from national regulatory bodies to be used to treat people.

This is good advice for any new treatment.

The problem with dubious stem cell clinics has been growing in recent years. In China, Mexico, India and elsewhere clinics promise “cutting edge” stem cell transplants for a long list of fatal or incurable diseases, like ALS, spinal cord injury, or stroke. They seem to be deliberately targeting affluent Westerners – although many of their victims have to raise money or mortgage their house to pay for the travel and cost of the treatment. The cost is often in the 10s of thousands of dollars, at time more than 100k dollars.

Such clinics typically advertise for customers over the internet. A survey of such sites indicates that most present their stem cell treatments not as experimental, but as “routine.” They offer testimonials to support their treatments, rather than published research.

These clinics are not doing proper science – publishing rigorous research and treating patients only with proper experimental protocols and informed consent. They are exploiting the public’s interest in a potential future therapy to prey on the desperate.

Such clinics are allowed to practice because of lax regulations in the countries in which they reside. Because of some bad press, Costa Rica, India and other countries are starting to take a look at such clinics – but official efforts to regulate them has been half-hearted at best.

It is therefore most welcome that professional and research organizations are seeing it as part of their mission to educate the public and directly address the misleading claims of snake oil peddlers. We need much more of this. Engaging with the public about misinformation and especially dubious health claims and products should be considered a core mission of medical professional societies.

Posted in: Politics and Regulation, Science and Medicine

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34 thoughts on “Cracking Down on Stem Cell Tourism

  1. Agreed. Perhaps the greatest danger to patients lies in the disconnected or uninvolved medical professionals–those who do not want to be engaged in the debate, those who do not take a stand and strongly advise their patients to avoid quacks, cranks, and crooks. Not being a clinician, I typically don’t have a directly role in advising patients, but I am astounded that so many physicians seem to avoid the (painful?) discussions with their patients.

  2. windriven says:

    “A survey of such sites indicates that most present their stem cell treatments not as experimental, but as “routine.” They offer testimonials to support their treatments, rather than published research.”

    Agreed that misinformation about medical therapies is unethical and should be illegal. Agreed that most of these therapies are not only unproven but might be characterized as speculative.

    But if I have ALS, an understanding of the risks and unproven nature of the therapy, and 100 grand in loose cash, on what basis should I be denied?

  3. Steve S says:

    Very good post. I have personal experience with this. My mother has emphysema and about 1 year ago some friends of hers told her about this clinic in Mexico where they do stem cell treatment for COPD. The friends wife was the one wanting to do this treatment, her husband was dubious but went along. They went down there and was told he got an injection of sheep stem cells from Austria and modified in Cuba. He was told to throw away his oxygen. He then had to buy some supplement stem cell enhancement pills sold at this clinic, just over the border in Nogales Mexico. He then had to return every 6 months for “boosters”. I told my mother to be careful and let me do some checking. I talked with two pulmonologists in town and they said there is nothing like it available as far as they know. I got on the internet and found this place. They also did stem cell treatment for CHF, autism, and a host of other diseases. There were ancedotal stories, no hard data. I called this clinic and asked some basic questions, I got very suspicious by their answers, I suspected a con game. I advised my mother not to do it. Her friend, who she did pulmonary rehab with, did not use his oxygen after the treatment. He died in his sleep 1 month later from COPD. The cost was $1000 for the shot and $50 for the supplement stem cell enhancment therapy. My mother is on oxygen, but still alive.

  4. Harriet Hall says:

    As I understand it, the biggest problem in stem cell research is not getting the stem cells where you want them to go but getting them to do what you want them to do. I recently toured a University of Washington research lab where they showed us a sheet of live human heart cells that were beating in unison in a petri dish. They had derived it from human skin cells by regressing them to a stem cell level and carefully bringing them forward again in such a way as to create heart cells. They started beating spontaneously. This is truly exciting stuff with great potential, but not yet ready for prime time. IMHO no one should be doing stem cell treatments outside of a controlled research study.

  5. Anarres says:

    ¡Thank you Steven!

    My father-in-law has Alzheimer’s, a few weeks ago I ran into an article about these therapies and I was wondering if they might help him. Only 1.000 euros.

    China, Mexico, India and … Germany, Netherlands… next USA?

    Now I find this:

    “We offer patients with degenerative diseases the opportunity to undergo an innovative and promising stem cell treatment.”

    “Promising” Oh man.

    http://www.xcell-center.com/

  6. Josie says:

    It makes me cringe every time I read about “stem cells” being injected into someone.

    Stem cells on their own will *not* do what you want them to do. The definition of a stem cell in practical terms is a cell that can propagate into all three germ layers, making a teratoma.

    What we want are cells *derived* from stem cells…we want those cardiomyocytes beating on a petri dish, we want pancreatic beta cells squirting out hormones we want functional neural cells.

    What we do not want is undifferentiated stem cells creating nasty unrestricted growth in a patient.

    I know it’s easy to just say we’re ‘injecting stem cells’ but it is not correct and it is misleading. I suspect it will also lead to unfortunate decisions made by people desperate for an uncomplicated cure.

    It also belittles the incredibly complex nature of stem cell research. Think about how many variables must be controlled to go from a pluripotent cell to a functional, fully differentiated cell type. Sure, mother nature does it all the time to produce healthy babies…but think about how many mistakes SHE makes in the form of developmental disorders and birth defects, and she actually knows what she is doing.

  7. Windriven – but you can say that about any con. The point is more that clinics do not have the right to sell fraudulent treatments, or to use deception in order to create a demand for their treatments, or to give experimental treatments and also charge for them, and not provide reasonable informed consent and proper research protocols.

  8. Robin says:

    Last year there was a small, hopeful study of MS patients published in Lancet Neurology. It involved chemotherapy to wipe out the existing immune cells before re-injecting stem cells taken from patient’s bone marrow. A larger study is ongoing. It’s a lot different than randomly injecting stem cells harvested from god-knows-where!

    It’s tough, though, for people who are chronically ill and impossible for the dying to wait for the science. Science takes time. And it’s difficult for patients with no science education to differentiate valid treatments from pseudoscience.

  9. windriven says:

    Dr. Novella-

    We are in nearly absolute agreement. My point is only that stamping out fraudulent practices will earn more proponents than will circumscribing personal choices.

    I’m not sure that I buy into the notion that experimental treatments must be done pro bono. It seems to me (without having carefully researched this) that many innovative surgical procedures evolved without a large body of no charge history. But each of your other criteria seem unassailable to me.

  10. Nescio says:

    There are some supplements being sold that claim to stimulate the body to produce stem cells. For example StemEnhance (you will get hundreds of thousands of Google hits).

    This stuff is made out of blue-green algae, and there are some studies that suggest it does stimulate bone marrow to produce stem cells. Is there any reason to believe these cells will magically migrate to a damaged part of a person and repair that damage? There are lots of fantastic testimonials (of course) but it seems somewhat far-fetched to me.

  11. qetzal says:

    Nescio,

    Even assuming that study is correct, it doesn’t show that the extract is stimulating bone marrow to produce stem cells. The effect is supposedly seen only 1 hour after consumption. That only suggests that pre-existing stem cells are leaving the bone marrow and moving into the systemic circulation. As the title indicates, they’re being mobilized. (Still assuming the study is true, of course.)

    As to your key question, no, there’s no good reason to think that there would be any beneficial effect from that.

  12. Josie says:

    Nescio -
    As far as I know the only stem cells your marrow produces are hematopoeitic stem cells –the progenitors to all your different blood cell types.

    http://en.wikipedia.org/wiki/Hematopoietic_stem_cell

    And sure…there are cells that magically migrate to areas of damage in your body …platelets (ok former cells :P), Natural killer cells, macrophages….

    So sure, it’s probably a good thing that your body produces hematopoeitic stem cells and sends their derivatives out to repair damaged tissues. I doubt that you need that ‘supplement’ to get the job done though :)

  13. daedalus2u says:

    Windriven, it is exploitive to charge for experimental therapies. The therapy is not know to “work”, to be safe and effective for what ever it is being used for. The expert who is giving it doesn’t “know” if it is safe and effective. He/she certainly cannot provide the known risk/benefit trade-off that is the quintessence of informed consent for patients.

    If you are allowed to charge for “experimental” therapies, then there is no incentive to make them non-experimental. Actually there is a disincentive because if you do the research and find that the therapy doesn’t work, do you abandon something that is bringing in patients, fees and is making profits?

    What aggravates me to no end is that for most disorders considered for stem cell treatments, the problem is degeneration of a whole tissue compartment. Why is the tissue compartment degenerating? If the tissue compartment already can’t support the cells that it has, what reason is there to expect new stem cells to somehow be supported? Other than wishful thinking?

    If it was known what was causing the degeneration in the tissue compartment, reversing that degeneration would be a much better treatment option than stem cells. For many tissue compartments there probably are already stem cells that can be mobilized to do minor repairs. No doubt that is a very complex process, and is a process that is disrupted during every degenerative disease.

  14. TsuDhoNimh says:

    http://news.yahoo.com/s/ap/20100624/ap_on_he_me/us_med_stem_cells_blindness_9

    ADULT stem cells taken from eyes have been multiplied in the lab and placed into damaged eyes. It appears to be repairing scarring in corneas.

    A far cry from injecting who knows what into a vein for $5K or $50K.

  15. In studies done in mice whereby they irradiated the bone marrow destroying all stem cells, a single adult stem cell (with a green marker) was reinjected. That single ASC rebuilt the entire bone marrow, so yes, they can truly become anything.

  16. BillyJoe says:

    windriven,

    “But if I have ALS, an understanding of the risks and unproven nature of the therapy, and 100 grand in loose cash, on what basis should I be denied?”

    Of what value is all your belief in, and promotion of, evidence-based medicine if, when it turns out that you are the patient, you are driven throw it all to the wind.

  17. windriven – All this talk of pulsating cardiomyocytes and and squirting pancreatic beta cells is making me think that clearly the risks of you ending up as a fleshing eating, zombie (with a libertarian bent) that oozes and pulsates as you lurch down the street dragging innocent civilians out of their cars, etc, could be a hazard to the community.

    Now that I think about it, reading this it seems quite shocking that stem cell research hasn’t crept into the horror movie genre. Guess they are still stuck on genetics or I’m just not up on my horror movies.

    This is not to demean the research of stem cells, which is fascinating and a very hopeful medical avenue, or windriven, who is clearly not predisposed to being a zombie, only sometimes I get an image in my head…

  18. daedalus2u – doctors often treat symptoms for diseases when they can not correct the cause. Why would this be different?

  19. Apparently, there is also a lot of research in stem cells to restore hearing loss. Cool stuff, hope I see some of it come to fruition.

  20. windriven says:

    @daedalus2u

    I’ll note again that there have been any number of procedures and therapies that were charged for before becoming accepted into the mainstream armamentarium. That said, I agree that most of the conditions for with stem cells are touted as ‘cures’ aren’t even appropriate targets.

    @BillyJoe

    I don’t have ALS and I wouldn’t throw $100k at stem cell therapy if I did. But there are many who would and I am hard-pressed to think of a good reason to prevent them so long as the experimental nature of the therapy and a clear disclosure of the risks are made.

    @micheleinmichigan

    It’s true, I am a brain-sucking zombie now. But you wouldn’t believe how well I can hear!

    So we don’t veer too far into the weeds, my point was that we are more likely to change minds by attacking fraudulent practices and by educating the patient base than by telling people that they will be prevented by force from seeking whatever therapies they wish , especially in otherwise hopeless situations.

  21. rork says:

    I want to mention again, in case of readers who aren’t aware because the popular press is so one-sided, that there are many labs interested in stem cells that have no interest in engineering tissues, or injecting cells. We just want to understand the molecules and pathways, since they are heavy hitters, of interest in diseases such as cancers (for me) or you-name-it (for others, e.g. obesity):
    C-Myc, KLF4 or 2 or 5, SOX1, 2, 3, POU5F1 (Oct4), are perhaps the most famous.

    Often we are trying to learn their effects in order to fight them.
    No magical instant remedies expected.
    Certainly we benefit massively from whatever the organogenesis or cell-tinkerers find too. Everyone is invited, bring a shovel.

  22. Scott says:

    @windriven:

    I don’t see anyone “telling people that they will be prevented by force from seeking whatever therapies they wish.” I just see people advocating shutting down fraudulent and unsafe providers of “therapies,” and when that cannot be done educating the public about the fact that they are fraudulent and unsafe.

  23. windriven says:

    @Scott

    There are always those who wish to proscribe by law things that offend them in one way or another. I am tempted to recite a litany of laws passed or proposed by those on the left and the right to illustrate my point. But that would engender a food fight that has nothing to do with the matter at hand.

    One presumes that the common goal here is to advance the cause of critical thinking in general and its application to medicine specifically. This will asphyxiate the scammers and charlatans much more effectively than declaring their woo to be forbidden fruit.

  24. Scott says:

    So you’re advocating allowing people to commit fraud and subject people to unsafe procedures without warning?

  25. Josie says:

    “Now that I think about it, reading this it seems quite shocking that stem cell research hasn’t crept into the horror movie genre.”

    Maybe not the movies…but in my head I certainly think up goofy horror plots all the time!

    Especially when I play Bioshock…

  26. Scott says:

    @ windriven:

    And in particular, there’s been NO suggestion I’ve seen of “declaring their woo to be forbidden fruit.” There have been suggestions that lying in order to sell their woo be addressed as fraud (which it is) and that they be required to inform their “patients” of the risks involved.

    So I really don’t see how you can possibly object UNLESS your position is genuinely that fraud should be allowed and customers have no right to know that what they’re being sold might kill them.

    If they can’t get anybody to buy their woo without committing fraud or concealing risks, then that’s not in ANY way suppression. THAT is informed consumers making informed choices.

  27. qetzal says:

    adultstemcells wrote:

    In studies done in mice whereby they irradiated the bone marrow destroying all stem cells, a single adult stem cell (with a green marker) was reinjected. That single ASC rebuilt the entire bone marrow, so yes, they can truly become anything.

    Destroying all bone marrow stem cells is not the same as destroying all stem cells throughout the body. So no, this does NOT show that adult stem cells can become “anything.” It shows they can become bone marrow stem cells.

  28. windriven says:

    @Scott

    “And in particular, there’s been NO suggestion I’ve seen of ‘declaring their woo to be forbidden fruit.’”

    Then you haven’t been following the comments on SBM for long. Truth be told, I’ve lobbied for outlawing something myself, both on SBM and in my state’s legislature: e-cigs. But that is because the marketing aims the product in part at children (i.e. chocolate flavored e-cigarettes). By definition children are not competent adults.

    “[y]our position is genuinely that fraud should be allowed and customers have no right to know that what they’re being sold might kill them.”

    Horse hockey. You are trolling. I’ve said ad nauseum in this thread and in others that fraud and deceptive practices should unequivocally be prohibited and practitioners prosecuted.

  29. Watergate says:

    There’s a family from my area with a toddler with optic nerve hypoplasia who is headed back from Qingdao, China this moment after 6 IVs of who-knows-what. This will have been their second $60,000 trip to China funded by rounds of small town fundraisers to get some “smart cells.” On their blog they write about doctors making the rounds and seeing if his vision is different after a few days of treatment.

    Back before their first trip I wondered what I could do to give them pause. I mean it is such a scam on a small child, you want to stop them. But what do you do? “Hello, I’ve come to interrupt your silent auction to crush you hopes and dreams!”

  30. Scott says:

    Then you haven’t been following the comments on SBM for long. Truth be told, I’ve lobbied for outlawing something myself, both on SBM and in my state’s legislature: e-cigs. But that is because the marketing aims the product in part at children (i.e. chocolate flavored e-cigarettes). By definition children are not competent adults.

    Actually I’ve been here quite a long time, and I virtually never see anyone advocate bans even on such garbage as homeopathy and reiki – and certainly nobody in this post or thread has advocating banning experimental stem cell treatments! And if you’re talking about comments made on other threads, you’re grossly off-topic.

    The closest anyone’s come on this thread is arguing that experimental treatments should be offered only as clinical trials and not charged for, which is only barely even similar to “denying” treatment or “circumscribing personal choices” or “telling people that they will be prevented by force from seeking whatever therapies they wish” or “declaring their woo to be forbidden fruit.”

    So what exactly are you responding to with the above comments? Precisely, with quotes.

    Horse hockey. You are trolling. I’ve said ad nauseum in this thread and in others that fraud and deceptive practices should unequivocally be prohibited and practitioners prosecuted.

    And then you object to the people saying that fraud and deceptive practices should be prohibited by arguing that they’re attempting to ban the procedures in question. I can’t see how pointing out this inconsistency can possibly be considered trolling. (Though reasons for you to CLAIM it’s trolling come quite readily to mind.)

    Realize in particular that you started out with replying to this:

    A survey of such sites indicates that most present their stem cell treatments not as experimental, but as “routine.” They offer testimonials to support their treatments, rather than published research.

    by saying this:

    But if I have ALS, an understanding of the risks and unproven nature of the therapy, and 100 grand in loose cash, on what basis should I be denied?

    Which is to all appearances the very definition of either a straw man or a non sequitur, as it bears no resemblance whatsoever to the quoted bit, OR to anything else said in the entire post.

  31. norrisL says:

    In the veterinary profession we have people doing stem cell therapy to treat dogs for arthritis. For $5000 they aspirate fat from the dog, centrifuge it, remove stem cells and inject into the dog’s joint. When I asked a nearby orthopaedic specialist his opinion, he said that there were no published papers and that the information he had was that the effect, if any, was less than the effect of non-steroidals. http://www.regeneus.com.au/resources/National_Dog_Magazine_Jun_09.pdf
    AdiCell claims to be non-invasive, but a few paragraphs on says that fat is removed by either liposuction or excision of a fat pad from the groin area. Sounds rather invasive to me.
    I would love to see stem cell therapy work in animals and in people.
    But I hate seeing people conned.

  32. Jonathan says:

    “I am hard-pressed to think of a good reason to prevent them so long as the experimental nature of the therapy and a clear disclosure of the risks are made.”

    winddriven: Well Perhaps this is semantics but doubt “clear disclosure” is the term we are looking for. I could easily disclose the known risks of a procedure in a way that would be difficult for even a medical researcher to make sense of.

    From there i assume the argument focuses on what is entailed by “clear” ultimately I think what we want is something like “such that they understand” which is clearly impossible to test.

    Anyway all of this is kind of setting up the question of “Whar meaningful statement of risk and success do
    you think can be made here”

    I mean the most inclusive and easily understood statement I can come up with is something like “What you are about to spend your money on is a bad investment.” or perhaps “You are more likely to be harmed than helped with this”. Neither of those seem very viable. Especially with all the latitude that companies and indusry have to provide more palitable and less rigourous evaluations.

  33. dclly says:

    I have congestive heart failure for 6 years now, both dilated cardiomyopathy and restrictive cardiomyopathy.

    I have a bi-ventricular pacemaker with an ICD.

    I also have third degree heart block, and without my pacemaker, my pulse is in the 20′s.

    I also have degenerative arthritis in my hips and back, and I have had one hip replaced and I am facing a second.

    I am also facing a knee replacement, and I required a cataract implant in my left eye five years ago.

    I am 56 years old.

    The doctors said I have done nothing to cause these things. I have worked out and watched my diet all my life and they call this a “random act of nature”.

    The treatments so far have kept me alive, but side effects are awful, and nothing has addressed the root cause.

    I flew to Germany from the USA a couple of years ago to try to get into a trial, but I was not “sick enough” because I could still walk .

    An you wonder why patients seek something that might actually get to the root cause while “science” twiddles it’s fingers?

    David Connelly

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