A surfer news site reported that a man recently died after getting an unproven stem cell therapy in Mexico.
The article is entitled Tragedy strikes in Mexico as Shane Dorian’s traveling companion for “life-altering” stem-cell therapy dies.
Shane Dorian is a famous surfer who hopes to fight aging at 51. As part of that effort, Dorian and a friend went to Tijuana.
Death after stem cell therapy in Mexico
The friend of Dorian, Dave Barnett, died there shortly after getting stem cells from a place called The Cellular Performance Institute.
“Dorian, taking to his own channel hours later, shared, he and Barnett spent the previous evening together after treatments, watched the Hangover then went to sleep. At some point, Barnett went into cardiac arrest and was unable to be revived even though many doctors were right there.”
Barnett went by the nickname Dozer Dave.
This piece on the death follows an earlier item in the same pub about how Shane Dorian was going to get the stem cells.
Comments on surfer mag
Interestingly, in the comments on the piece reporting the death, those who weighed in were highly skeptical of getting stem cell therapy in Mexico. One commenter noted this:
“I’m grossed out that before Shane even talked about his good friends death he talked about how great the process has been with getting these stem cells.
And then he tried to make it seem like Dozer was in poor health and that’s why he died and not these janky treatments????
I’m sorry, what. I would be absolutely livid at Shane if Dozer was a family member or friend.”
I wonder if Shane got a free treatment for promoting his adventure down there to get stem cells?
Somehow the article itself doesn’t note the possibility that the stem cells caused the death. Clinics often ignore these kinds of outcomes and, if pressed, say there was no connection. How would they know?
My thoughts go out to Barnett’s family. I don’t know if they have any options to get at the actual truth of what happened or to take action against the clinic down there if the “treatment” did cause the death.
What is the Cellular Performance Institute in Tijuana?
The Cellular Performance Institute is an unproven stem cell clinic in Mexico, although they call themselves a hospital instead. They sell umbilical cord “treatments” for many conditions.
Cellular Performance Institute claims to treat aging, neurological conditions (implying treatment of Alzheimer’s, Parkinson’s, etc), orthopedic conditions, and more.
I don’t see good science behind any of that. More generally, going to get stem cell therapy in Mexico is a risky business with little-to-no reason to think it’ll help or be safe.
Some of the place’s FAQ answers are red flags in my view. Under the FAQ that essentially asks “is there proof this works”, here’s their answer (emphasis mine):
“CPI uses protocols published in peer-reviewed medical journals that have demonstrated the therapeutic potential of cell-based intervention. Depending on the geographical location, some of these therapies may be approved or in clinical trials. We always do our best, but nothing works for everyone.“
That’s not reassuring.
Over the years, I’ve written about various stem cell clinics in Mexico. Such risks are not unique to places outside the U.S. A lot can and has gone wrong at clinics right here in the U.S.
One man dies receiving stem cell therapy without any proof of the therapy causing the death. How about these numbers? “How many people die from medical error a year?
Other frequently cited studies have placed the number of deaths as high as 250,000 deaths per year, which would make medical error the third leading cause of death, behind cancer and cardiovascular disease.”
And, there are another 250,000 deaths from properly administered hospital drugs as well.
Medical errors cause many deaths and suffering. I don’t think anyone disputes that. People defensive of stem cell clinics often like to point that out or also point out that traditional prescription drugs also cause many deaths. There are risks to such drugs, of course, and negative outcomes like deaths.
However, that doesn’t mean we should disregard deaths related to stem cell clinics just because there are fewer of them. The point is that such deaths or other serious adverse events related to stem cell clinic injections need to be reported, investigated as best as possible as to potential causes (yes, some probably are not related to the stem cells), and considered in the scope of risks when going to clinics. What seems to be happening instead is that many clinics often immediately disregard the incidents as unrelated to what they are doing and blame the patient’s pre-existing health issues.
Cool, would you like to write an article about the egregious medical error by 3 corporate entities here in the states that made me interested in stem cells in the first place. There are countless anecdotal reports of people experiencing life changing improvements for a variety of orthopedic injuries. I hope you can’t relate but the horror of chronic pain is not something that people just placebo themselves out of.
This is easy to explain.
FDA-approved drugs do sometimes make people worse, and even kill them. Those potential outcomes are reported in information about the drug, and are known because the adverse effects were identified during FDA-approved clinical trials.
For conventional drugs, the purity is overseen by the FDA, and the precise amount and instructions for a dose are clearly indicated. If someone is harmed, it is usually possible to determine whether the drug was responsible. Additional warnings may be required by the FDA.
In stark contrast, people who receive treatments in unregulated stem cell clinics have no idea what they are receiving. It could be no stem cells at all, or other kinds of cells, or cells that cause immune rejection, serious illness, or death.
If stem cell clinics would become regulated by the FDA, we would know exactly what is in the “medicine”, the recommended dosage and means of delivery, and whether recipients are at greater risk because of other medical issues.
When one goes to get brakes done, there is a reasonable expectation that the brakes installed will be 1) appropriate to the vehicle, 2) installed by skilled staff, 3) when you apply foot to brake petal the vehicle will actually stop.
The issue with any cellular therapy that has not undergone rigorous clinical trials clearly demonstrating their safety in a wide range of volunteers, as well as their efficacy in a wide range of volunteers, a ‘customer’ buying said cellular therapy product has NO evidence that said treatment will actually be of any value for their money.
One has to wonder if one’s brakes were failing, and a salesperson said “Spray this stem cell solution on your brakes. Don’t trust mechanics, this stem cell solution will fix your vehicles brakes, better than brake replacement”. Would anyone actually do this? No. And yet, despite no clinical evidence, there a people pushing ‘treatments’, taking advantage of people’s lack of understanding of cellular biology.
If it really works, prove it in a clinical trial.
It is obvious to me that some people that are expressing their opinion specifically here, have a lack of understanding with regard to the mesenchymal stem cell aka medicinal signaling cells. Here is a narrated presentation with lots of visual depictions of the MSCs and bio-mechanical process.
Arnold I. Caplan PhD of Case Western Reserve having brought this science to the forefront in 1991.
One needs to be open to new data driven science.
YouTube title “Arnold Caplan – The New MSC Bigger, Better and More CLINICALLY Useful” date of this presentation April 10, 2021
Web link: https://www.youtube.com/watch?v=YZAzz22wUvo
Dr. Caplan has been treated with MSCs in Panama. He wrote this in the Introduction to Neil Riordan’s book on stem cells.
I have seen two other clinics attesting to “approval” by Arnold Caplan PhD, and found that he eventually contacted the clinic and told them not to use his name as associated with the clinic. Dr. Caplan being a professional with integrity wants his name associated with knowledge of MSCs, bring it to the forefront of medical research, and Case Western Reserve University.
I am thankful to Dr. Riordan for investing in a clinic in Panama and opening up this type of treatment to be available, which it is not in the US. Some US clinics that are operationally structured to meet the constraints of the new FDA sponsored statue, and have individual state statute support, are able to offer treatment.
I find the cost in the US is prohibitive for most people like myself; and some clinics outside the US like in Panama, Cayman Islands, Costa Rica, Thailand, Colombia, and in Mexico charge exorbitant prices, in an attempt to gain maximum money. Over the past two years I have seen more clinics opened along the US – Mexico border, and the price has decreased slightly.
I too have had uMSCs multiple times, and IV exosomes, in an attempt to repair tissue and organs which have been injured/scarred due to chemotherapy, SCT mylobalation therapy in preparation for HSCT, and the resultant chronic GVHD.
It seems to me many people have their minds made up despite there being many review reports, and conclusions written in completed clinical trials that elude to the possible benefits of uMSCs. If one searches for MSCs in clinicaltrials.gov there are many past and ongoing clinical trials, some with published results and some without, as well in specific countries around the world.
This man lost his life in essence because the availability in the US is severely restricted, overly expensive, not thoroughly examined with multiphase clinical trials, and actively denied by the new statute sponsored by the FDA. Therefore the market has developed outside the US.
There is no biological patent capability (due to unlimited supply of material) for umbilical cord derived mesenchymal stem cells(uMSC), therefore the revenue generating aspect does not exist for any of the large pharmaceutical companies to be interested.
In all of the papers published by different medical institutions around the world not once has there been a report or results reported, with regard to the toxicity of uMSCs.
It is clinically researched extensively such that the bio-mechanism is known through observation, and generally accepted that the action is through the “peregrine effect”. Here is one of many papers published in PubMed about this pathway Sep. 17, 2014 “Paracrine Factors Secreted by Umbilical Cord-Derived Mesenchymal Stem Cells Induce Angiogenesis In Vitro by a VEGF-Independent Pathway” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4313407/
There is a company Mesoblast (proprietary product derived from MSCs) that is in final negotiations with the FDA for another clinical trial in an attempt to have approval for its use in pediatric hematopoietic stem cell transplant patients suffering from steroid resistant acute GvHD, and have no other option to mitigate this life threatening disease which is common after a SCT for a blood disorder.
To add to this understanding, many of these clinics, if not all, have sourced finished pure product from ISO 9001 labs that meet or exceed the FDA guidelines for laboratory operations in the US. Just because it is Tijuana does not mean it is questionable. In concert with questionable is the Covid spike protein and the health complications that have been discovered recently.
I believe if you haven’t researched extensively about uMSCs, you really don’t have the ability to make a constructive comment.
As the Brother in Law of the man that died, and as an Anesthesiologist who tried to help his brother regain his health, I can unequivocally state that David had severe sleep apnea and a heavy smoker and was at risk for respiratory arrest and death. He died in his sleep from respiratory arrest leading to cardiac arrest after a week of multiple non traditional medical treatments that included multiple ultrasound directed stem cell injections into tendons, labra and other specific joint structures.
Did the treatments contribute to his death? Maybe. He may have had a PE despite being ambulatory, or perhaps 12 hours post injections he had an inflammatory airway reaction sufficient to make his sleep apnea fatal.
What he did not have is sepsis nor a graft vs host reaction. He was in a hospital room and had been walking the hall at 3am, went back to bed, and was heard snoring shortly afterward. At 5 am the staff noted his snoring had stopped and checked on him, and found him in full arrest. A code was called and the team worked the ACLS protocol with successful intubation but were unable to obtain a sustainable rhythm.
Many of us tried to discourage David from seeking this treatment but he was convinced getting his joint pain issues resolved would then allow him to lose weight etc.
I met with the medical treatment team and was assured that a full internal review was underway, and that sleep apnea in particular would be considered as an indication for protocol changes or a contra indication to treatment.
David is dead. His death needs to be reviewed like any other sentinel event in a healthcare setting so our knowledge can be increased otherwise his tragic ending becomes nothing more than blog fodder for those wishing to push their agendas.
John Reed MD
Former Heath Technology Risk Assessment Analyst for C Everett Koop
Research Institute of Scripps Clinic Immunology Researcher
Current Anesthesiologist
@John,
Sorry for your loss. Thanks for leaving a comment and sharing info and your perspectives. I’m glad to hear they are going to investigate.
John, I’m sorry that this happened. I’m an avid critic of unregulated “stem cell” clinics, and understand that the only damage usually done is to the bank account, not the body. This does not mitigate my deep concern about the claims that MSCs or hematopoietic stem cells can cure any disease. HSCs are valuable for replacing bone marrow cells that are killed by chemotherapy, and for correcting genetic blood disorders like SCID and sickle cell anemia. But in spite of more than a thousand clinical trials using MSCs, none has been approved by the FDA.
@John, Do you know if David was also given IV stem cells? That seems riskier for someone with his health conditions.
He had reached the maximum number of cells they were willing to use so they did not do the IV route.
Good to know.
Just a comment as well that this blog has played a big role in educating the public about stem cells and other technologies and helping the public avoid unnecessary risks at clinics and wasting tons of hard-earned money.
Blogs can serve a very valuable purpose if done responsibly and with an educational mission at heart. Hundreds if not thousands of academic scientists now run blogs around the world.
Do you know how many he got and from how many umbilical cords? It sounds like there was logic behind the dosing.
Sorry for your loss. I’ve had these injections myself in my spinal facets and have helped me greatly. Can you say if he had the IV treatment as well?? I’ve read that when IV is done the stem cells stage up in the lungs initially before moving into the bloodstream. Thanks again for your words
This is tragic. To re-iterate, there is no evidence that umbilical cord treatments have any benefit outside of use as a transplant source (BMT) for certain hematopoietic conditions. Anyone who suggests these cells can be beneficial should have the treatment done as part of a registered clinical trial (clinicaltrials.gov). That way, we can better learn what works and what does not. The practitioners who think these treatments work would benefit from a well-designed clinical trial that demonstrates efficacy. The fact the don’t demonstrates they likely don’t actually believe the treatments provide a significant benefit.
@Dan,
It is so sad.
Thanks for making some excellent points.
Clinics selling unproven cells (and their fans) also are quick to dismiss adverse outcomes such as this death as unrelated to the stem cell procedure.
The mantra when something catastrophic happens is basically, “well, they would have died, had a heart attack, lost their vision, etc. anyway. It wasn’t our fault.” At best, they’ll then stop doing the procedure that caused the severe outcome, but at worst they just keep doing it and putting people at risk for profit.
They also tend not to report deaths or other severe outcomes to government officials, in databases, or in papers. Many such outcomes are thus invisible in a sense.
Dan Kaufman, check this out
“Umbilical cord “derived” mesenchymal stem cells (MSCs) found to halt the progression of type 1 diabetes in phase 2 trial. They gave umbilical cord stem cells to patients recently diagnosed with type 1 diabetes and it appears to have stopped the disease from getting worse.”
https://www.reddit.com/r/science/comments/14lusr1/umbilical_cord_derived_mesenchymal_stem_cells/
And check it out Paul Kneopfler’s employer is currently running a clinical trial where they’re trying to cure spina bifida using placenta derived MSCs.
“World’s first stem cell treatment for spina bifida delivered during fetal surgery, in California. Three babies have been born after receiving the world’s first spina bifida treatment combining surgery with stem cells.”
https://www.reddit.com/r/Futurology/comments/yw3iqh/worlds_first_stem_cell_treatment_for_spina_bifida/
I am hearing anecdotal stories from the Stem Cell Institute in Panama and Dream Body Clinic in Mexico, that they are literally curing people of congestive heart failure using umbilical cord mesenchymal stem cells!!!! Do you understand how revolutionary this is!!!!!?
I think it’s only a matter of time til a company successfully passes a phase 3 trial and gets FDA approval, and then watch out!!!! Because the world will never be the same again. This is going to change the world.
@Jake. The MSC trial done at Karolinska for diabetes is interesting. This seems to be a well conducted trial, though subsequent Phase 3 trial is needed on a wider group of patients. As MSCs are known to be immunosuppressive, the result is reasonable. My only concern is the authors are also members of the company. That is a bit of a conflict of interest. Better would be to have an independent group do the trial.
Regarding the “anecdotal stories from the Stem Cell Institute in Panama and Dream Body Clinic in Mexico”, this is exactly the problem. They are anecdotes! As is often stated, the plural of anecdote is not data.
I have no problem if MSC-based treatments are demonstrated efficacious for certain diseases based on well designed clinical trials and a proper review from FDA, EMA or similar review. Just don’t base your expectations on anecdotes.
My most sincere condolences to the family. It’s a terrible tragedy but we can’t jump to conclusions about cause of death. More information is needed.
I got umbilical cord stem cells in China and it helped me a lot. It’s true, nothing works for everyone. We have to do our own research and come to our own conclusions.
Over-reliance on a very specific type of data while completely ignoring real world outcomes is tantamount to being mired in academic and regulatory myopia. The FDA policy on SCT is anachronistic and dangerous.
People aren’t just numbers in a data set. To reduce them to such is inhumane, barbaric and patently unethical.
This raises so many more questions! Truly sad. Recently researched where some of “these” clinics were using bolus IV with a baffling amount of saline. One would think that saturation would greatly lower O2 alone in the bloodstream.
“little-to-no reason to think it’ll help or be safe.”
You’re showing your bias against umbilical cord MSCs. Umbilical cord MSCs are going to revolutionize modern medicine in my opinion. MSCs have been through multiple phase 3 trials at this point and not a single person died so yeah it’s pretty darn safe as long as it’s done right. I mean the new mRNA vaccines aren’t 100% safe and yet the FDA approved that, I mean the new mRNA vaccines have definitely killed a few people.
Paul are you aware how biased you are against MSCs? You’re super biased! Check your bias.
@Jake, A guy dies and you are instead focused on your excitement over MSCs.
For me, it’s all about the data. So far, the data aren’t there for MSCs to get all the way to an approval in the U.S. Selling them now at clinics is not OK.
Here’s a link to an article written back in 2016 suggesting that medical errors are the 3rd leading cause of death in the UNITED STATES. (not MEXICO) https://www.hopkinsmedicine.org/news/media/releases/study_suggests_medical_errors_now_third_leading_cause_of_death_in_the_us
I don’t see anything in this article blaming “unproven” stem cell clinic practices as being major contributors to the high mortality rate of patients upon receiving medical treatments right here in the good ol’ U.S. of A.
@admin Since it’s about “the data”, where is your data on what this particular guy was actually given? Without any data, you then conflate the “MSCs” this guy received with MSCs administered by other clinics. You don’t have any data on how this treatment was administered either. For all any of us know, this guy could have been given saline or just about anything. It is Tijuana after all.
Someone else brought up MSCs in the comments.
Paul, I truly wish to see MSCs successfully pass a phase 3 trial. You said to me on X that you thought umbilical cord MSCs would probably eventually be approved by the FDA for something, well what is that something? Which disease do you think umbilical cord MSCs can successfully treat? Perhaps spina bifida? Will you please answer this question?
Somatic mesenchyme, aka MSCs, will probably be approved in the US, as it has in other countries,for graft vs host disease, although their mechanism of action is vaguely understood if at all. I think that MSCs derived from iPSCs will be a better source, but still they will never replace anything.
MSCs are considered to be safe because they are transiently present- they don’t engraft.
Well, I suppose the death is caused by IBMIR due to the UC MSCs.