A brief report in the NEJM today highlights the risks facing patients who get stem cell treatment from dubious clinics as one such patient recently developed a large spinal tumor.
Dr. Aaron L. Berkowitz and colleagues describe how this patient who received a mixture of several stem cell types from an overseas clinic was later diagnosed with a very unusual neoplastic growth on his spine.
The data point to the tumor arising from the stem cell treatment as it was genetically distinct from the patient.
Oddly the cancer defied classification as a particular tumor type. This may in part be due to the fact that he was given a mix of embryonic, fetal neural, and mesenchymal stem cells. It’s unclear which cell type(s) might have led to the tumor. Notably he apparently didn’t get any immunosuppression, which raises the question of his own immune response to the transplants.
This patient received at least three transplants at different locations across the globe outside the U.S. While risks of stem cell offerings are higher in certain countries, there are many stem cell clinics here in the U.S. that sell stem cells without FDA approval and with little if any data to back them up.
The NY Times just published an article on this case and identified the patient as Jim Gass as well as providing more details including the start of the chain of events:
“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 impact of sports celebrities getting unapproved stem cell treatments and the press about such situations can be far and wide on the public.
The NY Times article actually starts off much later in Mr. Gass’ stem cell treatment saga in a way that is very disturbing and powerful, “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 authors of today’s NEJM piece concluded: “Such experimental treatments must be studied in a safe, regulated environment.”
This is a very sad, sobering situation.
The article should be titled, “A Cautionary Tale of FETAL Stem Cell Tourism.” No wonder the general public is so confused about cell types. Horrible outcome for this patient, that’s why it’s so important educate the public on ADULT stem cells for treatment of disease and conditions.
@jennifer,
He got a mix of stem cell types including both adult and fetal. While it seems very likely the latter were the main problem, there’s no way to know.
@admin There are well-documented cases of fetal stem cells causing tumors in humans. The fact that embryonic stem cells fundamentally tumorigenic is well known. There is not a single documented case of mesenchymal stem cell therapy causing tumors in humans.
@Jennifer Ziegler – do you know this for sure? Isn’t it better to wait for clear evidence before making such statements? I agree with you that it’s important to educate the public on stem cells, but simply preempting scientific data with a headline like yours is surely not the way to do this.
Thing is Barbara, in citing those stats, you attempt to play down what happened, but those stats are irrelevant to the facts that these clinics should be shut down – including those in the US. On the other hand, and despite your obvious resistance, you have acknowledged that the dangers of these clinics are real, so welcome aboard. Let’s raise the bar.
Anna – The bar is already too high when there is no access which is why patients go offshore. This story is a very isolated incident and I think you know that. I am grateful for the treatments I’ve had. They’ve improved my quality of life immensely. The good clinics, good doctors are doing a tremendous job of helping patients. Have you had a chance to have treatment or visit a clinic? Do you have major health issues? If not, I just don’t think you have the experience to judge. And please don’t be condescending by telling me welcome aboard. It’s very insulting and unprofessional.
How can the bar to patient safety be too high when people are dying from the malpractices in the clinics? Is therapy more important than survival?
You say the story is a very isolated incident – how do you know this? I am researching the topic and can tell you the incident is NOT isolated, There were around 300 cases of SAEs in unregulated clinics in 2015 – and these are only the ones for which we could get feedback.
“Have you had a chance to have treatment or visit a clinic? Do you have major health issues? If not, I just don’t think you have the experience to judge.”
We have visited 14 clinics in the US, Mexico, Canada, Germany, Russia and Thailand – we are visiting 6 more in China and Taiwan next month. In some we registered as potential patients (I have a chronic autoimmune disease for which cell therapy is often offered in these clinics). Some of the claims I have heard in these places are simply frightening, and of course the proof of success is zero. So yes, I think I have the experience to form a rational opinion.
What is most sad is the many patients I met in the clinics who have paid money they barely have for therapy that simply are not going to work. And some are risking their lives, as we have seen in this report.
Anna – I think in all fairness you should identify yourself and let us know who is paying for you to travel the world doing this. And who is we? How do you pick and choose what clinics to visit? What kind of credentials do you have to investigate the clinics you are going to? What type of access are you getting to base your evaluations on?
As for your statement that you feel badly that patients are paying for treatment that simply isn’t going to work, I am assuming that this isn’t fact, but just your “rational” opinion.
The case cited here is not the norm. I know a lot of patients who have had safe and successful stem cell therapy and none has paid $300,000 for a strange cocktail such as what this man got. Why should I believe anything you have written when it seems as if you are deceiving others by your actions such as registering as a potential patient? Are you planning on publishing your findings? What is the end goal of doing what you are doing?
I just don’t find your comments to have any merit at this point. There is just too much information lacking to substantiate any of what you’ve said. The old saying the devil is in the details comes to mind.
@Barbara,
You’re being awfully aggressive in your response to Anna in terms of demanding information. Is it then OK to ask if you still sell supplements for a profit to patients after they get their stem cell treatments? http://www.seachangeforlife.com
Without actual data, we cannot really know what the “norm” is.
Sure it’s okay to ask Mr. Knoepfler. I’m not sure what your point is. I have nothing to hide. Do you charge for sponsors on this blog? Does anyone really care if you do or if I am part owner of a small business and have been since 2007? I doubt it. I also have a non profit foundation if you’d like to know.
Who is Anna? That’s what I’m asking or is it someone you want to cover for? No one should expect privacy when commenting on your blog. That’s quite obvious. If Anna wants to make such statements, then what’s wrong with vetting her (or him)? And why are you feeling that you need to respond instead of Anna? It’s all a bit strange in my opinion.
@Barbara,
But your small business targets stem cell patients with a product that makes specific health-related claims.
I don’t know Anna so I do think it would be valuable to know more about her research and she has added a comment.
FYI – My business partner and I both have COPD. We started our small business (and it is small, let me assure you) with an emphasis on supplements that could possibly help patients with COPD and that is still our main target market.
We started to get requests for other products and so we have expanded our line to include post treatment supplements that are popular with many doctors. We do not outside marketing. It’s basically word of mouth. Several of the products we offer were developed by doctors. We personally try all of the supplements that are offered for lung patients. If we don’t like a product, we won’t sell it.
I’m a researcher in bioethics at King’s College London, working on a study of reporting of clinical studies in cell therapy. The project is funded by the EC Horizon2020 program. Does that make my post more credible? No, because neither you nor I command such respect as to be believed at face value. But much of our data is taken from published clinical study reports from 2008-2015. These you can also access (e.g. through PubMed, etc.) and discover that your statement, “This story is a very isolated incident.” is false.
I now read you have a vested commercial interest in playing down the death of a stem cell patient. To keep this quiet and make unsupported statements about clinical safety of stem cells, might be considered, in your own words, insulting and unprofessional. I can declare I have no vested interests in any clinics, therapeutics or otherwise.
Anna – There you go again making assumptions. I have no commercial interest in playing down the death of a patient. By the way, Mr. Gass has not died according to the NYT’s article if you read it. I’m not sure why you think there is a “Gotcha” moment from Paul’s reply. Most small businesses are not incorporated to not make a profit, so I’m lost as to the point of why what I do for a living is relevant to this discussion.
I guess you are not familiar with my forum whatsoever. I have red flag warnings against some clinics and doctors warning patients about their enterprises. I am also a patient with a disease that has no cure. I have improved my quality of life immensely from stem cell therapy. My dog has had treatment too and the results are quite frankly amazing. I know so many patients that have benefited from stem cell treatments. One can now see again. Another is out of her wheelchair. And yet another is no longer needing supplemental oxygen. The list goes on.
Your research doesn’t seem very relevant to me because disreputable clinics are most likely to not give you the facts that you really need to assess them and they are likely to not be publishing anything. I just don’t see the purpose in your study. Patients will not care. Disreputable clinics will still operate and be disreputable.
I also say taking grant money for the study makes you more than a disinterested party. Indeed the EC Horizon 2020 program states, “The Commission’s top priority is to get Europe growing again and to increase the number of jobs without creating new debt.” So for you, this is a job. You need to produce something to continue to be employed. You are getting paid for traveling around and pretending to be a patient. I’m questioning the ethics of that, but I guess you might fancy yourself an investigative reporter of sorts. For me, it’s about patients being able to have access to the treatments of their choice and potentially leading a far better life than they could without stem cell treatment. It’s about staying alive. And for the record I never endorse clinics or doctors when patients ask. My forum is for discussion and support for patients who have had stem cell treatment or are thinking of having stem cell treatment. I do not get paid for that work, except for the wonderful compliments that I get from readers.
As for the reason I said this was an isolated incident is in the overall picture it is. It just doesn’t represent the norm. Most patients are opting for adult stem cells, not strange concoctions of the type Mr. Gass had. Continuing to expose clinics that would give a patient something like that is a good idea, but trying to lump them in with good doctors and clinics and scaremongering patients about stem cell treatments will never resonate with the majority of patients seeking therapy.
Anna:
I would love to hear more about your odyssey. You can contact me directly.
Jeanne, it would be great to get your feedback on our project. Some goes for Paul who contacted me via email. An interim report is currently being drafted, containing aims, methods and initial data, which would be an ideal intro.
Want some really interesting statistics? 130 Americans are killed by deer every year. 65 are struck by lightning. 100 are killed by bees. 20 are killed by cows according to the BackPack the Sierra website. I didn’t want to go into how many are killed by FDA approved drugs or automobile accidents as those statistics are much higher due to mass participation. I chose instead to take a look at hiking which has a much lower participation rate and yet an alarming yearly death rate. It appears to be much safer to get stem cell treatment than risk hiking. The same is true for almost any human activity. There is always some risk in what we do.
I am sorry for Mr. Gass, but he was seeking treatment outside the U.S. because there were no options here. That’s the real shame in all of this. Clinical trials are so limited that only a few can participate. Harsh regulations on adult stem cell therapies are limiting innovation and access. What’s dubious is why so many have such a great interest in stem cell treatments. Is it possibly because billions of dollars are at stake? I surely don’t see a similar uproar about the risks of hiking.