Of all of the different challenges negatively impacting the ability for orthopedic stem cell therapy to be adopted by all practicing physicians, the biggest single barrier is the entry of chiropractors and other alternative health practitioners into the space. Why? Every new technology goes through an adoption phase, but one of the things that can derail it is issues with credibility. This morning I’d like to introduce you to an important investigative documentary on Stem Cell Institute of America, created by documentary filmmaker Doug Orchard, that is essential in protecting the public and allowing this field to continue.
As I’ve blogged before, because of my spine-centric and holistic practice style, I’ve often been called an honorary chiropractor by my friends who are chiros. Many of my best friends are chiropractors. I routinely refer back and forth to local chiros and other alternative health practitioners. Hence, I’m a big fan of the concepts that were first put forth by D.D. Palmer because, if nothing else, it forced the world to look at how big a role the spine plays in musculoskeletal health.
This video is not about chiropractic. It’s about a bait-and-switch misrepresentation involving amniotic products. There are medical doctors who are doing this as well. However, right now, the single biggest purveyor of this problem is a chiropractic-practice management company called Stem Cell Institute of America.
While I love chiropractors, a small group within the chiro community has been pushing the envelope for many years. These chiropractors have slowly added more and more medical services to their practices to enhance their income. This is usually accomplished by hiring a physician assistant or nurse practitioner. The problem with this arrangement is that the training of these midlevel practitioners was designed to be paired with a practicing physician. They are supposed to act as an extender for the doctor while under his or her direct supervision. Why? They have far less education and hands-on training than the average MD or DO physician. However, in most of these chiro offices, no on-site medical supervisor exists. In fact, all too often, the practice management companies that help these chiro offices hire these midlevels arrange for a distant physician to act as a supervisor in name only. In fact, he or she may have never seen or stepped foot into the chiro clinic.
The initial services offered by these “medicalized” chiro offices were relatively benign, like medical weight loss and hormone-replacement therapy for antiaging. These were low-risk offerings, so perhaps suited to using a midlevel provider with, at best, distant physician supervision. However, more recently a danger line was crossed that creates a public health and safety issue.
The problem began when chiropractic-practice management companies began to realize that orthopedic stem cell therapies were becoming in vogue. Adding these services to a chiropractic office could add big bucks to the bottom line. However, the management companies also had a problem. The midlevels working in these clinics didn’t have authorization by their state medical boards or the training to perform stem cell harvest procedures, like bone marrow aspiration or liposuction. In addition, most reputable education organizations in this field refused to train them due to safety issues. Finally, chiro offices aren’t set up to perform these procedures. It was the solution to that problem that caused the current public health crisis and set up an even bigger one down the road.
If midlevels couldn’t harvest the patient’s own stem cells, then the only option for chiropractic management groups was to get “off the shelf” stem cells. The problem was that no such product existed that had been approved by the FDA. Hence, the sales reps who were hawking amniotic fluid and membrane offered a solution. They could have simple live/dead viability tests performed on their dead tissue derived from live births that seemed to show that some of the cells were alive. Since the tissue had some small percentage of living stem cells when alive, they could claim it had living stem cells once it was processed and turned into a product. Hence, these midlevels could perform “stem cell injections”! However, we regrettably rained on that fictional parade.
If you read this blog, you know that, long ago, we were approached by an orthopedic sales rep who claimed to be selling vials of amniotic fluid and membrane that had millions of live stem cells. We said, great, that would be cool if true, but we trust orthopedic sales reps about as much as the guy selling used cars down the street, so send us some samples and we’ll test them. Our lab then went about diligently testing these samples, and while they appeared to have some live cells on simple live/dead stains, more sophisticated testing using flow cytometry and culture-based colony formation failed to show any living and functional stem cells. For more info on these concepts, see the video below:
At that point, we were intrigued but had other research priorities, so we gave the project to the Interventional Orthopedic Foundation (IOF). They tested many more amniotic and cord blood products and again found them all to be dead tissue. We moved on, knowing that while these birth tissues may have some role in regenerative medicine, it wasn’t as a stem cell source.
Stem Cell Institute of America (SCIA) started out life as Physician Business Solutions (PBS), This was a chiropractic management group that would add medical services to chiro offices. SCIA first got on our radar when they began massive marketing campaigns in major US newspapers, claiming that they were performing amniotic stem cell procedures in chiro offices. First, we knew this wasn’t true based on our testing. Second, we had a serious public health concern that performing any medical procedures in chiro offices was irresponsible. We and other physicians began looking into the background of the company and unearthed that their president had been convicted of health care fraud by billing for services that were never rendered. Yikes!
IOF had tested many amniotic tissue products, including one called PalinGen Flow. This amniotic product was also found to have no living cells. Turns out that they weren’t the only one testing PalinGen Flow, as a PhD sent a letter to the org stating that he also had tested the product and found no living and functional stem cells but that he felt the product could be effective through native growth factors. Ultimately, IOF responded to his letter and went about their business.
There has been some mystery surrounding the amniotic product that SCIA was using. I’ve heard of several companies that claim to be working with the company. We recently had an office-staff member make a call to a local SCIA chiro clinic, and they claimed to be using PalinGen Flow. More research into the SCIA website again turned up PalinGen Flow. Given that none of these products that were tested had any living stem cells, which actual product they used seemed unimportant, but at least we had something on which we could hang our proverbial hat.
Sometimes people miss their calling in their initial chosen profession. Doug was in a corporate job and then bailed to pursue a dream of making films. Turned out that he was quite good at it. The investigative film above is his extraordinary work.
So to put it all together, SCIA is injecting dead and nonviable amniotic tissue and calling it a stem cell procedure. This is clear based on their print, TV, and social-media advertising and was confirmed by taping one of their many seminars. Since the expectation is that they are injecting live and active stem cells (as stated in their seminar), IMHO, this is classic bait and switch. However, you look at the evidence and draw your own conclusions.
The upshot? Enjoy the investigative video. We have many chiros paying midlevel nonphysician providers to perform procedures that are beyond their practice scope and without an on-site physician supervisor. We know based on testing that the stem cells in the amniotic products that are being injected are dead. So is this stem cell fraud?
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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.…