Stem Cell Institute of America Review: Changes Its Biz Plan?
POSTED ON IN Industry News BY Christopher Centeno
I've blogged before about "Stem Cell" Institute of America (SCIA), a group of chiropractors offering dead amniotic tissue injections and fraudulently calling these "stem cell" procedures. Looks like SCIA just sent out an e-mail to their clinics that states that they will move away from offering amniotic and cord stem cell products (due to FDA regulations) and instead move toward offering "Marrow Cellutions" (MC). So what is MC? Given that MC is a device we have already tested, I've got a lot to say about the topic.
What Is Stem Cell Institute of America?
Stem Cell Institute of America goes by many names. I have blogged on it before, but suffice it to say that there is no "Institute," just a semi-deserted storefront in downtown Canton, Georgia. I know this because a local physician who practices close by decided to check up on this company and found just a few employees with phones on card tables. In fact, the last time we checked, its incorporation documents had lapsed in the state of Georgia. The company seems to have evolved from a chiropractic-practice management consultant. These groups are common in chiropractic offices and allow practices to add services to earn extra income. These companies have traditionally accomplished this by adding physical therapy, a physician assistant, or a part-time physician to a chiropractic office. Several years ago, one of those groups rebranded itself as SCIA. Turns out, the person who presents himself as president of SCIA (Brent Dedelitch, DC) is a convicted felon. Basically, in his former chiropractic office, he created what he called the "hit list," or a group of patients on whom he would bill insurers for services that were never rendered. The practice would also split the proceeds with some of the patients. He was also part of an FBI sting operation where he was recorded. You just can't make this stuff up. SCIA began aggressively carpet-bombing major US newspapers with front-page ads last year and then luring patients to high-pressure sales events. We taped one such event in Denver, where the chiropractor presenting the seminar trashes bone marrow stem cells and extols the magic of "amniotic stem cells." The problem was, of course, that we had tested the product he was using (PalinGen Flow), which contained no live cells at all and certainly no live stem cells. Hence, the presentation was the worst type of medical consumer fraud.
What Is Marrow Cellutions?
Marrow Cellutions is a device that purports to perform a better bone marrow aspiration (BMA). A BMA is a procedure by which a doctor draws the liquid portion of the bone marrow. The goal of the procedure is to then place this bone marrow aspirate into a centrifuge to isolate the stem cells within the mix. Several years ago, the Marrow Cellutions device hit the market. It was initially marketed as a better trocar to draw bone marrow. Had the company stuck to that claim and the device been inexpensive, that would have been fine. However, given the high price of the device (as much as $1,200), the sales were poor. The device was then rebranded as something that was capable of drawing so many stem cells that you didn't need to centrifuge to isolate cells. This sales pitch worked much better. The device is essentially a fancy version of the more common Jamshidi trocar, a stiff needle used to penetrate the bone to draw bone marrow aspirate. It allows the doctor to place the device deep into the bone and then slowly retract the device while drawing small amounts of marrow along the way. The company put out a few poorly done white papers that claimed to show that the device could dramatically increase the number of stem cells without having to run the aspirate through a centrifuge. This caught my eye as if this were true, it could revolutionize the way we draw marrow for our procedures. However, I believe the claims of device companies and orthopedic sales reps like I believe the used-car salesman down the street. Hence, I wanted to test the device myself to see if it was worth the high price and additional work of using the contraption.
Our Marrow Cellutions Test
I first knew I really wanted to test the device while I was lecturing at the IOF 2017 conference last February. One of the speakers was a veterinarian from Texas A&M, and she really liked the device for her use of harvesting stem cells in horses. She felt that she was getting a lot more stem cells but had no concrete data. Turns out that when I followed up on this later, the device didn't work as well as she thought, and she has since changed her opinion, but I didn't know any of that in February of 2017. I asked the sales rep at the conference for sample devices and thus began my several-month ordeal of trying to test the device. Suffice it to say that the company and our clinic could never agree to a testing regimen. After they refused to sample devices for us to test, I then arranged to purchase several of these expensive contraptions from a colleague. We then, after months, began our tests. Our results are below. We basically compared the number of stem cells obtained with the MC device against a common disposable trocar on the other side of the pelvis. Unlike the tests used by the manufacturer, we used the MC device in the same way we used the inexpensive trocar. We sent the marrow samples to the lab blindly and let them figure out stem cell yield. The results were disappointing at best and downright embarrassing at worst. The expensive device failed to perform any better than a trocar costing 1/20th–1/50th as much! In addition, concentrating stem cells in a centrifuge smoked any output from the device. Coincidentally, another physician also tested the device around the same time and got the same or similar results. Hence, we decided to bypass purchasing and using Marrow Cellutions. (For more info on the data below, see my final Marrow Cellutions review.)
The SCIA and MC Deal
This week, SCIA sent out an e-mail that states that the whole network of chiropractors will now switch from using cord blood "stem cells" (really dead tissue) and instead will use the MC device. Additional research shows that they are still using amniotic products. This is quite a switch, as most of these clinics don't have any physician on site performing procedures, but, instead, use physician assistants. The company cited regulatory concerns with cord blood products. This switch is problematic for a few reasons:
- Most of these clinics are chiropractic offices without any operating or dedicated procedure rooms. Performing a BMA in a chiro office room is problematic for many reasons, not the least of which is sterility.
- Most of the clinics have no on-site physician, and in my opinion, a BMA is outside the scope of practice for a physician assistant (PA) or nurse practitioner in the type of clinical setting. Most of these mid-level practice acts only contemplate minor in-office procedures, like removing stitches or lancing a boil. While specialty programs exist for mid-levels to safely perform BMAs, these practitioners are paired with an oncologist and practice in medical centers and hospitals where there is significant emergency assistance available if anything goes wrong.
- Based on our data and that of another physician, the MC device doesn't produce anywhere near the number of stem cells as most common centrifuge devices. While this may be less of a big deal in young patients, in many middle-aged and older patients (who are the target of the SCIA advertising), based on our data and that of others, the procedures will underperform.
- SCIA has made a point of bashing marrow-based procedures, claiming that "amniotic stem cell" procedures were better. Now they have to retool the marketing to demonize amniotic procedures and somehow come up with a rationale to use a device that, according to our data, can't yield anywhere near as many stem cells as the physician down the street performing an actual stem cell procedure.
The upshot? I've come to expect nothing less from SCIA. Ever since I have been observing this company, it's been all smoke and mirrors disguised by major media buys. The company isn't an institute but, when we checked, a semi-deserted storefront on a small-town main street sited next to the Hallmark shop. It has never actually performed any stem cell procures using amniotic fluid or membrane, as these were dead tissue products. This was despite aggressive and high-pressure sales events where the company claimed that they were injecting millions of live and functional stem cells. Now they have chosen to use a device that our testing and that of others shows doesn't really produce nearly as many stem cells as the more commonly used same-day stem cell procedure. They will also now presumably have midlevel providers perform BMAs who in my opinion aren't qualified to perform the procedure in the setting of a chiropractic office. Judging by results, why would I expect anything more?
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