Another day, another stem cell clinic pops up! While I really can’t keep up with it all, I do like to take one of the more ridiculous ones every week or two and expose the insanity. Usually these clinics are created by physicians who barely know what they don’t know. Case in point is one featuring a nifty little graphic that’s pretty much 100% misleading or just plain inaccurate. So let’s get started; this should be fun!
Do you remember the game of telephone when you were a little kid? One person would tell another some fact, and then that person would tell another, and so on. By the time the fact got through four or five people, it was so macerated that it barely resembled what the original person said. This is a bit like the wild west of stem cells in 2017. There are few real orthopedic stem cell experts who have been doing this a long time and have published a lot of key original research. Then there are physicians who heard those physicians speak, and then those physicians became lecturers and taught other physicians, and so on. However, unlike other fields of medicine where standards for education are strictly enforced and everyone must learn one agreed-upon curriculum, 99% of physician stem cell education today is being handled by pay-for-play conferences, where the only educational criteria are who can pay to access the podium. Hence, it’s a bizarre game of telephone exemplified by today’s graphic.
Before I get to the graphic, I want to first point out some trends that I see. Most clinics and manufacturers offering stem cell treatments or products play it pretty straight. However, the problems begin when the exaggeration starts. We’ve seen this with the following:
Another common exaggeration is when clinics new to this space claim that large amounts of new cartilage can be grown in patients with no cartilage left (“bone on bone”). So instead of underpromise and overdeliver, we have overpromise and underdeliver.
A colleague sent me this graphic from a website that just popped up claiming two clinics focusing on back pain:
I’d like to take these claims one by one, as each is either not true or only half true and misleading. Let me explain.
Huh? Given that there is no FDA-approved product called “Fiber Matrix,” I had to do some digging. The clinic appears to be using porcine (pig) bladder injected with the cells. There is a common form of this product that is commercially available called ACell. Any physician can buy a bottle of ACell, so there is nothing proprietary about it. The good news is that when we tested it in 2010, the stem cells seemed to like it; the bad news is that we don’t a have a single clinical trial or even case series published using this material with stem cells in spine care or for any orthopedic application. So does it work to improve outcomes? Your guess is as good as mine.
The rationale behind this concept is that stem cells used in tissue engineering are often used with a scaffold. This is something for the cells to grow on. However, given that bone marrow concentrate contains platelets that get activated by free collagen, every bone marrow concentrate injection already forms nature’s best scaffold: a marrow clot.
First, as we have seen these past few weeks with the FDA stem cell crackdown, a fat stem cell procedure, known as stromal vascular fraction, is illegal. More likely, what the doctors are talking about is a fat graft, which is not a stem cell procedure (i.e., there are no free stem cells). Bone marrow concentrate is a stem cell procedure. However, as you’ve read here, there is no such thing as an umbilical-cord-derived stem cell product that contains viable and functional cells. Meaning the products that the clinic uses contain dead tissues. Had they ventured to test these products themselves rather than just believing the hard sell from an orthopedic device sales rep, they would know that by claiming live and functional umbilical cord stem cells, they are misleading patients.
This is always a funny argument. For spine injections, while they can be performed with ultrasound imaging, they can’t be done well. Why? Ultrasound is incapable of showing where the cells are going into spinal joints and around nerves. This is because these areas are often blocked by bone, which ultrasound can’t penetrate. X-ray–based fluoroscopy can see where these cells will go because it can see through bone.
Can’t you perform these injections with ultrasound only? Yes, but you can’t do them reliably and well. Who wants to blow big bucks on a stem cell procedure only to find that the cells never made it to the spot where they were supposed to be?
Will fluoroscopy damage your stem cells? Nope. We actually did these tests way back in 2007 and saw no difference in cells in monolayer culture flasks that we exposed to fluoroscopy versus not. Is there any research by anyone else showing that using fluoroscopy hurts stem cells? Nope. In fact, a US National Library of Medicine search under the terms “mesenchymal stem cells” and “fluoroscopy” shows 20 hits, all not on this topic. In fact, most of the human studies listed are ours. So where did this “fact” come from? It appears to be pulled out of thin air.
In summary, having ultrasound and fluoroscopy is a big deal as it lets you use what’s best about both technologies. Why wouldn’t a clinic have both? Cost! You can get a passable ultrasound unit for 20–30K. Having a high-end ultrasound unit and a super C-arm, high-end fluoroscopy unit in the same room ups that cost to about 200K! In addition, you also need a special room with custom drywall, which is two to three times as big as the usual size and an expert radiology tech to run the machine, which costs another 70–80K a year. So it’s 30K for a little ultrasound unit versus hundreds of thousands of dollars to do this right.
As the first physician in the world to perform most of these orthopedic stem cell injections, it’s awful to see this happen to the field. Random claims being made with no substance have no place in medicine, let alone regenerative medicine. Taking on each one of these hyped websites is literally a full-time job. As a result, I can only expose a few of the crazy claims out there, writing blogs between patients or when it’s dark outside at 5:30 a.m., as I do have a real job!
The upshot? As you see, some of the above is true, some misleading, and some outright false. This is pretty much par for the course out there. So be careful as stem cell hype abounds on the web!
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About the Author
Christopher J. Centeno, M.D. is an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. He is board certified in physical medicine as well as rehabilitation and in pain management through The American Board of Physical Medicine and Rehabilitation.…