What's scarier than dubious stem cell clinics? A naturopathic stem cell clinic!

I've frequently written about bogus stem cell clinics that use hard sell techniques to sell unproven and expensive "stem cell treatments" to desperate patients. For instance, I deconstructed the story claiming that hockey great Gordie Howe improved so markedly after a severe stroke, thanks to stem cells offered to him for free (because of his celebrity) by a dubious stem cell company (Stemedica) through its Mexican partner (Clínica Santa Clarita). The whole incident basically opened my eyes to just how unethical the for-profit stem cell clinic industry is, as clinics use hard sell techniques more akin to used car salesmen to peddle potentially dangerous therapies even right here in the good ol' USA. The level of corruption and lack of ethics are truly astounding. Indeed, some stem cell clinics have followed the Stanislaw Burzynski model in getting patients to pay to be on dubious clinical trials that are designed primarily to sell product rather than to answer any sort of scientifically important question.

The problem, of course, is that very few stem cell therapies have compelling evidence for efficacy and safety. Yet that doesn't stop dubious stem cell clinics all over the country from selling treatments claiming to improve or cure everything from heart disease to lung disease to cancer to even autism, all with minimal evidence that what these clinics are doing can do anything of the sort. That's why I view it as very much a good thing that the FDA has recently made noises about cracking down on stem cell clinics, a move that's long overdue. I hope it continues.

Regardless of whether the FDA's new loving attention to stem cell clinics is sustained or not, yesterday I learned of something very, very disturbing. Let's just put it this way: What's scarier than an unregulated, dubious stem cell clinic selling "stem cell"-related "cures" for lots of money? I'll tell you. It's an unregulated, dubious stem cell clinic selling "stem cell"-related "cures" for lots of money run by naturopaths. I kid you not. there's a clinic in Park City, Utah, the Docere Clinics, in which a naturopath is advertising stem cell therapies that it offers. The naturopath, Harry Adelson, ND (Not-a-Doctor) is described thusly:

Stem cells, specifically mesenchymal stem cells (MSCs), have been called “patient-specific drug stores for injured tissues” because of their broad range of healing abilities. MSCs are directly responsible for healing damaged tissues after injury. Upon encountering damaged tissue, they release proteins that decrease inflammation, kill invading microbes, and trigger the growth of new connective tissues and blood vessels. In the case of severe damage and cell death, MSCs have the ability to turn into healthy versions of damaged or destroyed cells that they encounter.

When we take MSCs from your own bone marrow, from your own fat, or from both, concentrate and/or isolate them, and then inject them directly into your problem area, we ‘trick’ your body into thinking that there has been a new injury without actually causing any tissue insult, and you get a second chance at healing. In the case of advanced osteoarthritis where the population of stem cells has been depleted, we are repopulating the area with stem cells, and thereby restoring the body’s natural ability to heal itself.

The only good thing I can say about this is that Docere Clinics don't claim to be able to treat spinal cord injury, autism, or cancer. Believe me, that isn't saying much. Because, quite strategically, Docere Clinics does treat all manner of musculoskeletal pain syndromes, some of which stretch the imagination as conditions that would need something like stem cell therapies. For instance, like many "regenerative medicine" stem cell clinics, Docere claims it can treat osteoarthritis and avascular necrosis. It also claims that it can treat back pain of various etiologies and bone spurs. (One wonders why on earth one would need a treatment as expensive and radical as stem cell therapy in order to treat bone spurs.) Ditto carpal tunnel syndrome, whose pathophysiology is pretty well understood and which is treated quite effectively by carpal tunnel release surgery. (I know. I've that surgery 15 years ago and it basically cured my carpal tunnel syndrome, other than a minor twinge every now and then.)

Looking at the list, I see no condition for which stem cell therapies have been shown to be efficacious or safe, but I do see conditions that are primarily ones of chronic pain, which means that they are likely to be particularly susceptible to placebo effects. Without rigorously designed randomized, placebo-controlled, double blind clinical trials, it would be very difficult to determine whether any therapy has a significant impact on these conditions. Is there any RCT data supporting what Not-a-Dr. Adelson does? Nope. None of that stops him from doing what naturopaths love to do and cosplaying a real doctor by wearing scrubs in all his videos and pictures on the clinic website:

Dr. Adelson began his training in regenerative injection therapy (prolotherapy) in 1998 while in his final year at The National College of Naturopathic Medicine, in Portland, Oregon after having been cured of a rock-climbing injury with prolotherapy. During his residency program in Integrative Medicine at the Yale/Griffin Hospital in Derby, Connecticut, he volunteered after hours in a large homeless shelter in Bridgeport, Connecticut, providing regenerative injection therapies to the medically underserved while gaining valuable experience. He opened Docere Clinics in Salt Lake City in 2002 and from day one, his practice has been 100% regenerative injection therapies for the treatment of musculoskeletal pain conditions. In 2006 he incorporated platelet rich plasma and ultrasound-guided injection into his armamentarium, in 2010, bone marrow aspirate concentrate and adipose-derived stem cellls, and in 2013, fluoroscopic-guided injection (motion X-ray).

Prolotherapy, of course, has been around a long time but lacks convincing evidence for clinical efficacy. The same can be said of platelet-rich plasma (PRP). Neither have particularly compelling evidence for utility in the conditions for which they are commonly used. It's possible that PRP might have an effect in some conditions, but there really isn't much in the way of decent evidence to show that it does.

But wait! Did you do a double take when you saw that last sentence, wherein a naturopath is using fluoroscopy to guide his injection of stem cells. Just let that sink in a moment. How on earth could he ever be qualified as a naturopathic quack to use fluoroscopy for anything? Get a load of where he injects the cells, too:

Of the fluoroscopically-guided injections that we perform, one that stands out is the injection stem cells into the intervertebral disc. Discs are structures that are rich with nerves, but are the least vascularized tissue in the body. The way discs maintain hydration is through movement; as the disc moves, hydration comes from the vertebral bodies (bones) above and below. When we lead sedentary lifestyles or suffer traumatic injuries, the discs can become ‘desiccated’, meaning dehydrated. A dry disc is an extremely painful disc. Being able to inject a dry disc with stem cells is the primary reason we became interested in fluoroscopically-guided injection.

That's right, Not-a-Dr. Adelson is injecting "stem cells" of unclear provenance into cervical discs because he thinks the stem cells will somehow un-desiccate them and turn the old, atrophied cervical disks to shiny new ones. Here he is cosplaying a real interventional radiologist:

Yes, he's injecting into cervical and lumbar disks. What could go wrong? Well, there are nerve roots nearby that could be damaged. One can damage the disks themselves. There's a reason why becoming a board-certified interventional radiologist takes as many years as becoming a surgeon does. Perhaps what's most disturbing about this is that Not-a-Dr. Adelson trained at Yale's integrative medicine program. I wonder if Steve Novella knows his school's quackademic medicine program admits naturopaths. It led me to find that the Director of the Yale Adult and Pediatric Integrative Medicine Program is a naturopath. Although the Yale/Griffith Hospital integrative medicine program appears to exist no more, in its day it did have naturopaths as residents, as evidenced by this advertisement for a talk on naturopathic approaches to pain management, given by one of the naturopath residents.

So does Not-a-Dr. Adelson have any evidence to back up his treatment? Well, he has a TEDX talk:

It's basically an anecdote about a veteran of the Iraq/Afghanistan wars named Chris who had severe chronic low back pain due to a degenerated L4/L5 disk, suffered as a result of injuries due to his bad luck of being too close to two two different IED explosions. Apparently this veteran came to him asking him to inject stem cells into his disc. At about the 1:20 mark, you see how Adelson justifies his unethical actions. He basically portrays the options, but paints the ethical option (not using stem cells) in the worst possible light, as abandoning the patient. He portrays the other best option, enrolling the patient on a clinical trial, in an equally bad light, dismissing it saying that, well, you know, you have to be aware that you might bet a placebo. The next option he jokes about, namely taking the patient to "my offshore stem cell clinic" to treat him. Then, he portrays what he did, using an unproven technique that hasn't been validated scientifically or in clinical trials on a single patient, as the best option, the heroic option, the "can do" option. He even brags about how doing an autologous stem cell transplant is no different than doing a hair transplant. He also justifies his action by his own "conversion experience" using prolotherapy to treat his shoulder injury from rock climbing. I also learned the name of the surgeon who taught him how to do injections. Not surprisingly, it was a doctor, an orthopedic surgeon, who runs a dubious stem cell clinic in Florida.

Not-a-Dr. Adelson makes the claim that the outcomes were "so much better" than PRP that stem cell treatments "instantly became 100% of my practice," bragging about how he traveled to various Central and South American stem cell clinics. One man he mentioned was Carlos Cecilio Bratt, MD, who, it turns out, runs a stem cell clinic in Venezuela, and runs what sounds like an assembly line doing stem cell treatments. (One wonders why he hasn't published his results.) He also went to the infamous Stem Cell Institute in Panama City. He also went to Ecuador. Finally, he found MDs and DOs willing to teach him how to use a C-arm and do fluoroscopy. Naturally, Adelson finished his story by bragging about how much Chris claims his pain has improved and how good his results are. Did he mention any clinical trials? No, of course not. He does have an unrandomized, highly dubious clinical "trial," though. Unfortunately, what he doesn't have is any mention of whether he had institutional review board (IRB) approval to do that retrospective chart review and to publish it. Worse, he doesn't have anything resembling real informed consent:

Patients presenting to Docere Clinics in Park City, Utah, between July 15, 2014, and November 15, 2014, who were deemed candidates for autologous stem cell therapy, were asked to choose between being treated with BMAC [bone marrow aspirate concentrate] or SVF/ PRP [stromal vascular fraction suspended in platelet rich plasm]. e conversation can be summarized as follows: “I can do a bone marrow aspiration and treat you with BMAC, with which I have ve years of experience and am aware of data supporting its use, or I can do a lipoaspiration and a blood draw and treat you with SVF suspended in PRP, which has the potential to provide us with a far greater yield of stem cells and, theoretically, a superior outcome. However I have little experience with it and there are very few data supporting its use.” Patients then self-selected into the BMAC or the SVF/PRP group.

Then, he changed the protocol:

During this period and during preliminary follow-up with patients, I began to notice a trend that many SVF/ PRP patients reported higher satisfaction than those in the BMAC group, but the remainder were experiencing no improvement at all. Beginning November 16, 2014, I be- gan o ering patients SVF prepared as described above but suspended in BMAC rather than PRP, hypothesizing that the combination could o er the consistency of BMAC with the augmented outcomes of SVF.

This is half-assed, "make it up as you go along" clinical research at its most dubious. Adelson then looked at his outcomes using a retrospective survey. Basically, everyone appears to have done roughly the same. Given that there wasn't a hint of a whiff of a statistical analysis or power calculation, that's basically that can be said. As for the lack of IRB involvement, Adelson appears to be taking advantage of the fact that the IRB requirement, strictly speaking, only applies to human subjects research funded by the federal government, carried out at an institution (e.g., a university) that receives federal funding, or when a clinical trial is being done as the basis to seek FDA approval. True, some states have their own laws requiring that any research inside their borders have IRB approval according to the Common Rule, but I don't know if Utah is one of them.

Not surprisingly, Adelson seems utterly oblivious to what we already know about invasive surgical procedures: There can be a significant placebo effect any time you inject anything into the spine or discs. I like to use the example of vertebroplasty for lumbar spine fractures due to osteoporosis. It's been shown convincingly in at least a couple of good randomized, placebo-controlled trials to be no better than placebo. The usage of vertebroplasty has even declined as a result, albeit not nearly as much as it should have. (Yes, doctors sometimes share something in common with not-a-doctors; the unwillingness to give up treatments that science has shown to be ineffective.) Without a good RCT, it's impossible to tell if Not-a-Dr. Adelson is getting the results he gets due to placebo effects or not. Yet he just cruises along, using an unproven therapy. Worse, who knows what Adelson is actually injecting? He's described his technique for isolating stem cells, but one thing I see lacking is any characterization of the cells to demonstrate that they are what he claims they are. I also see a lack of followup images to demonstrate that the concoctions injected into the discs have had any effect at all biologically in rehydrating and renewing them. Basically, Adelson's clinical "evidence" is a joke, and a bad one at that. Yet, Docere Clinics continue to offer the treatment, and even offer a 10% discount per patient to current patients who refer new patients. Capitalism!

But how can this be legal? Apparently, in Utah, it is. Britt Hermes contacted the Utah Division of Occupational and Professional Licensing and received this reply:

Naturopath Harry Adelson who harvests and injects stem cells (using fluoroscopy!) got the approval of Utah authorities.

This is bullshit. pic.twitter.com/c6DaYVZHJe

— Britt Marie Hermes (@NaturoDiaries) August 31, 2017

Yes, in Utah, naturopathic quacks can basically do anything, science be damned. Or so it would seem. Worse, Not-a-Dr. Adelson is not alone. There are quite a few naturopaths out there offering prolotherapy and "stem cell" therapies. Be afraid. Be very, very afraid.