Stem Cell Institute of America: Back to Its Old Tricks?
POSTED ON 5/30/2018 IN Regenerative Medicine Education BY Chris Centeno
I've blogged about Stem Cell Institute of America (SCIA) a number of times. They are at the epicenter of the rapidly expanding trend of faux “stem cell” procedures being administered to patients at chiropractic offices throughout the United States. Recently, I had written that the company appeared to be changing its ways and perhaps even subscribing to the FDA's new guidance documents. However, that didn't last long. In fact, the following statement, which is included in SCIA's contract with its “clients”—that is, the chiropractors who hold themselves out as being SCIA providers—perfectly encapsulates SCIA's position in the industry: "No warranties, promises or representations of any kind, expressed or implied, are given as to the nature, content, effectiveness, legality or safety of any product represented in the presentation, including the presence or population of viable mesenchymal stem cells." Huh? No guarantee of stem cells? Let me explain...
What Is SCIA?
SCIA is a management group that consults with chiropractic practices regarding how to improve revenue by adding “stem cell” procedures to their suites of services. SCIA began as Physicians Business Solutions and provides their “client” chiropractors with marketing materials, marketing training, and access to allogeneic tissue products, which in virtually all cases it calls “stem cell” products. SCIA takes the position that it is not a provider network, but it does feature a provider panel, and I remain in the dark about how that works.
Chiropractic “Stem Cell” Offerings Sweeping the Nation
Chiropractors are selling dead amniotic and umbilical cord tissue injections, usually administered by nurses, and claiming that these are “stem cell” injections that will regrow tissue and even cure severe arthritis. They often charge more than a real stem cell procedure delivered by a specialist physician. See my video below: [dk-video id="hxj_xuQvJnI" autoplay="false" button="white" title="" show-title="false" width="70%" align="aligncenter"]
SCIA Tries to Clean Up Its Act
Recently, a medical colleague who had attended an SCIA online webinar noted that he was getting unsolicited e-mails from the company. These e-mails appear to be sent out not only to the company's "clients" but also to its entire e-mail list. He regularly forwards these e-mails to me, and as I understand it, they are, in fact, public documents, as my colleague has no provider agreement with SCIA and has never been a "client." A while back, I blogged on the fact that SCIA had made comments at its national meeting that it was cleaning things up. I was actually intrigued by the sudden change of tack. Recently, this seemed to be confirmed in an e-mail sent to its public list. This included statements like: "We at the Stem Cell Institute of America have been doing as much as possible to be and remain compliant with the FDA rules, regulations recommendations. In order to best protect you, it is necessary that you do follow our recommendations. Not doing so, will not only harm yourself but, will also harm your other group members. For that reason, any member who is found to be doing anything contrary to our recommendations will be terminated." That sounds very tough and appropriate given that they clearly have members who are claiming to offer live stem cell treatments but are injecting dead tissue. The e-mail goes on to state that the following is not allowed:
- The treatment of multiple incurable diseases. The e-mail claims that any provider found to be doing this will be terminated. However, this statement didn't apply to those practitioners using the patients own stem cells for "their own wellness". This seems to imply that these are practices using these therapies for age management.
- Promising a result or outcome
- Pricing - this is where it gets weird. The e-mail says, "It is important that you set your pricing for your treatments and that you feel comfortable with them. You need to justify your fees. The Institute recommends a discount to patients if they want to buy more than one injection, but does not set your pricing structure which is up to each individual clinic." Huh? This seemed to be a statement about making sure clinics justify the crazy high prices they charge to have a nurse inject dead tissue (often much more than having a physician expert perform a real stem cell procedure), but then veers off into selling more product?
- Advertising. It gets even weirder here. The e-mail says, "We have done our best to inform you that it is vital that you do in fact offer amniotic as well as adult stem cells in your clinic. We have informed you of both fat and bone morrow companies/procedures. If you do not offer both adult and amniotic solutions it is vital that all advertising states that your lectures are on stem cells as well as amniotic and or other advanced regenerative options." I have no idea of what they're trying to say here other to acknowledge that amniotic tissues contain no live stem cells?
- SVF is illegal - this makes sense as two clinics were just sued by FDA that offer this type of fat stem cell treatment.
- Mode of Administration - They only recommend the administration of amniotic or umbilical cord tissue into joints. This statement appears to have been made because some clinics have been also performing intravenous injections.
- Scope of Practice - Here they want the clinics to make sure that the mid-levels (mostly nurses) can legally perform the procedures and remind their clients that in no state is a chiropractor allowed to perform the procedure.
So, while a bit strange, it appeared that maybe SCIA was trying to clean up its act?
SCIA Reverses Course Again
This week another e-mail was sent announcing that the new "FDA Compliant" materials were ready for download. These include patient PowerPoint lectures. The e-mail also included a link to a "Client Agreement". This statement in that agreement is priceless: "No warranties, promises or representations of any kind, expressed or implied, are given as to the nature, content, effectiveness, legality or safety of any product represented in the presentation, including the presence or population of viable mesenchymal stem cells." Huh? The "Stem Cell" Institute of America makes no guarantees that any product it offers to its providers actually has stem cells? In the actual e-mail we see this: "For those of you that are doing the latter we have added to the Vault a great piece of research that validates the presence of MSC's in the Wharton's jelly and also shows that it is the best source. It goes on to show that there are over 100 research studies that have been completed or are in the process, treating a whole host of conditions, all with successful outcomes." First, SCIA is right back at it. On the one hand, you must sign an agreement as a provider that there may be no living stem cells in the products you use. On the other hand, here's an email from the "Stem Cell" Institute of America claiming that Whaton's Jelly Products have live stem cells?
What is Wharton's Jelly?
The umbilical cord from a baby has a part of it that carries blood, which is where "cord blood" originates. There is another part that provides structural support to the cord itself and this is called the "Wharton's Jelly". This tissue does have stem cells, but there is no evidence that any commercially available product that contains Wharton's Jelly contains any viable or functional stem cells. Why? Because an umbilical cord from a birth would be stored in a fridge at the hospital, transported to a processing lab, stored some more, then processed, then frozen, and finally shock thawed in a doctor's office using a protocol known to harm cells.
Selling "Stem Cells"
Now that we know that SCIA takes no responsibility for there being any live stem cells but in the same breath claims to sell live stem cells, this little humdinger from the e-mail shouldn't come as a surprise: "Last but not least Dr. Steve and Dr Brent are going to do a combined training in Pittsburgh where we will do both the updated lecture training as well as the updated sales training in one day. This will enable everyone to be trained on how to do the speaking and the sales correctly and compliantly." Yep, note that we don't see that the chiropractors that run SCIA (one of whom is a convicted felon) are going to Pittsburgh to train their providers on how to pick the correct candidates for the therapy medically, they are there to teach people how to sell. Why should I be surprised? The upshot? You can't make this stuff up. In conclusion, SCIA seemed to be cleaning up its act but now seems to right back at its old tricks. I am not surprised...
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