Tip of the iceberg? Scary stuff from international stem cell clinics

Author: David Kent, 08/02/16

Last week, a good friend of mine forwarded me a correspondence from the New England Journal of Medicine (NEJM). I was expecting to read about a new drug being tested in clinical trials or maybe a neat scientific perspective on leukemia biology, but what I got instead shocked and saddened me. The title of the article – Glioproliferative Lesion of the Spinal Cord as a Complication of “Stem-Cell Tourism” – is foreboding on its own and highlights the dangers of seeking out unproven (and often completely untested) cell therapies.

The article charts the journey of a man, Jim Gass, who wanted to mitigate his post-stroke complications. He sought various stem cell therapies comprised of mesenchymal, embryonic, and fetal neural stem cells that were injected into his spine in three different clinics across the world (Mexico, Argentina, and China). After receiving these cells, the man developed back pain, problems urinating and paraplegia – a terrifying ordeal. As a stem cell biologist, I cannot even begin to fathom how this was expected to work.

It is an all too common story of stem cell tourism: desperate patient seeks an ‘experimental’ therapy to cure their disease and ends up in a foreign country with a bag full of hope (…and cash). In many cases, nothing much happens (aside from the bag of cash swapping hands) but in some cases, like this one, the consequences are dire. According to the New York Times piece reporting on the same case, Mr. Gass spent $300,000 including travel – just to rub salt in the wound.

But the scariest part of the article for me was when the doctors described what they found inside their patient: “Although the lesion may be 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.”

Not only had this treatment made this man incredibly unwell, but the cell infusion had created something not before observed in people. As well, the clinical team at Brigham and Women’s Hospital also proved, using several standard lab techniques, that the cells did not come from Mr. Gass. So what the heck were they and where did they come from?

Experiments like the ones reported here will set the legitimate cell therapy field back decades and we need to bring a halt to unproven therapies. This sort of personal story, in the most highly cited medical journal, will bring even more bad press to bogus stem cell therapies and I, for one, hope that it catalyzes the medical and scientific communities to act. This is an extremely serious issue that needs to be addressed.

This particular NEJM correspondence also highlights another important issue for public health care providers and private insurers. If a patient seeks a therapy in a foreign country (in this case three different countries) and significant complications develop, who treats the complications? In many cases, this will fall to the country of residence (especially in a public system) so it seems reasonable that some investment from these countries should also go toward preventing people from seeking/undertaking unproven therapies considering the post-treatment complications can be incredibly expensive.

So what can we, as a community of scientists, do? Well, as I have highlighted on Signals before, the International Society for Stem Cell Research (ISSCR) has created an excellent resource for people to use when considering cell therapies (stem cell or otherwise!) to treat their condition. Particularly useful is the page entitled “Stem Cell Treatments: What to ask” which allows patients to print information and request answers from the clinic where they are seeking therapy. I also recommend reading this patient advisory that contains useful information and links to additional resources, and this one too.

This approach is quite passive though and I would like to advocate for something more proactive that exposes cell therapies that are not bona fide treatments. Let’s create a resource that breaks down cell therapies by type and identifies routine proven therapies and the countries that offer them and also individual organizations that have listed new therapies not on the approved list.

Most would probably be difficult to have a full scouting report on, but the list of clinics with poor outcomes – such as the one in this NEJM correspondence – would continually be growing. An extreme version of this would name any physician involved in the trials (both in administering as well as supporting/referring).

Legally, I imagine this is quite tricky since a society like ISSCR (or any individual for that matter) could find itself in some serious battles with companies/clinics that feel they have been unfairly maligned by the media or by anecdotal patient accounts. But we need to do something; we cannot just sit idly by, as experts in stem cell biology and medicine, and watch these clinics prey on the hopes of desperate patients. (As an aside, it is interesting that the NEJM correspondence does not mention the names of the clinics that treated Jim Gass.)

Readers, what do you think? Can you imagine a sophisticated online tool that could be used to fact check and verify what clinics across the world are promising? I look forward to hearing your ideas.

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David Kent

David Kent

Principal Investigator at University of Cambridge
Dr. David Kent is a Principal Investigator at the University of Cambridge in the Cambridge Stem Cell Institute (http://www.stemcells.cam.ac.uk/research/pis/kent). His laboratory's research focuses on fate choice in single blood stem cells and how changes in their regulation lead to cancers. David is currently the Stem Cell Institute’s Public Engagement Champion and has a long history of public engagement and outreach including the creation of The Black Hole in 2009. He has been writing for Signals since 2010.
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2 Responses

  1. SammyJo Wilkinson says:

    Dave, we don’t need to vet overseas clinics because patients don’t want to go overseas, we want to be treated in the U.S. by reputable doctors. Cellular therapy using your own autologus cells should not required RCTs at this point, because safety is already there in ph 1-2 trials, just look in pubmed. We need a new model, based on Observational Treatment Studies, tracked in a nationwide registry.

    This is what your peers are saying,and these two are certainly leaders in the field of human treatment with cellular therapy.

    Dr. Ricordi is saving lives from type 1 diabetes, and he founded The Cure Alliance.

    Dr. Caplan is called “the father of mesenchymal stem cells” since he them in 1991, and went on to design one of the first human trials for expanded MSCs at Cleveland Clinic, for multiple sclerosis.

    Caplan has been proposing his “Progressive Approval” plan since 2014, and it looks like Japan took him up on that. Patients with unmet medical needs, who have failed all conventional therapies are in great need of cellular therapies that heal and repair, with a great safety profile. Rather than the harsh medicine of orthopedic joint replacements, or chemo and immune suppression that autoimmune diseases are treated with.

    Please, take a look at this new editorial, and share what you think about it with your readers.

    *Editorial – Improving the regulatory framework for cell therapy does not equate to deregulation”

    Prof. Arnold Caplan, Case Western Reserve University
    Camillo Ricordi, MD, University of Miami

    An excerpt of what these esteemed cellular scientists recommend for their industry:

    “Stem cell clinics that are currently operating lawfully under the designation of “practice of medicine” would not be subject to the new regulatory pathway. FDA currently allows limited use of autologous, homologous, minimally manipulated cells if donor consent and good tissue practices are observed.

    New legislative proposals offer the opportunity for improved oversight over stem cell clinics operating outside the practice of medicine. New regulatory approaches can and should involve close monitoring, providing FDA with the data necessary to assess long-term safety and efficacy in this rapidly emerging field. All individuals and organizations that deliver cell therapies, including those that fall both within and outside of the practice of medicine, should participate in reporting to a new, publicly accessible registry.”

    • David Kent says:

      Thanks for the comment SammyJo – I’ll definitely have a read through the Caplan editorial, thanks for the link.

      Regarding the need to vet overseas clinics, as long as people are seeking unregulated treatments (and they are…), we as a community need to provide as much help as possible to steer them away from clinics that have an unproven track record.

      Regarding approved trials in the US, I’d remind you that these are trials for a reason – we don’t yet know if they will work.

      If a patient reads “therapy in a regulated trial, might work, not sure just yet” compared to ” effective cure for disease X” (the latter of which some international clinics claim) they are going to consider this and I don’t blame them for looking.

      We need to push back against the unproven ones whilst also taking cell therapies through regulated clinical processes as well and promoting the ones that show effective treatments for diseases (of which I agree there are some and these are a fantastic boon to the field – and the patients!).

      As I said though, I’ll have a read through the editorial and may well write about this in the coming weeks.

      Thanks again for your comments.

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