As I sit here and write this, I’m in a bit of a time crunch. You see, getting better and better at regenerative medicine is hard. There are physicians to educate in advanced image-guided injection procedures, research that needs to be completed or published, fellows that need to be taught, advances in the lab and the clinic that must be vetted, a public to educate, and the list goes on and on. However, what if it were all easy? What if you could buy amniotic stem cells in a vial and give that product to every physician extender technically licensed to stick a needle into someone, regardless of whether they were as well trained as a physician or not? That would be an incredible business, but at the same time, it would be cutting a load of ethical corners. However, that’s what a national network run by an ex-con chiropractor convicted of billing for fictitious patients is doing. Let me explain.
Amniotic “Stem Cells”
If you read this blog regularly, you know that there are no viable stem cells in amniotic tissue products. Every amniotic product that has been independently tested by a third-party nonprofit confirms that once this tissue sits in a hospital OB ward, sits in a processing center, is frozen, and is then shock thawed in a doctor’s office, no viable and functional cells remain. Hence, it’s outright consumer fraud to claim that using an amniotic product is a stem cell procedure since the material has no living and functional stem cells. However, that hasn’t stopped a chiropractic network called “Stem Cell Institute of America” from claiming that it’s performing amniotic stem cell injections.
The Plot Thickens
I covered this amniotic stem cell chiropractic marketing scheme a while back. A colleague recently sent more information about Stem Cell Institute of America (SCIA) that sheds even more light on its origins. What he unearthed fits with the type of blatant consumer fraud we see from this organization.
For example, in this presentation to chiropractors about how to increase practice revenue, Dr. Brent Detelich, a chiropractor, is presented as the president of SCIA. Who is this guy? It turns out this chiropractor was convicted of healthcare billing fraud that involved billing insurance companies for patient visits that didn’t happen and then splitting the insurance money with the patients! Yikes!
Taking Apart the Statements from the SCIA Presentation on How They Can Increase the Revenue from Chiro Offices
Listed at the chiropractic economics site above is a presentation by Dr. Detelich. Let’s take that apart and look at just a few key statements:
First, we find this graph that seems to show that amniotic tissues have many, many more stem cells than the ones found in your adult body:
However, this is very misleading. First, the amniotic products that SCIA uses have no living cells, so their functional stem cell content is zero. Second, in looking at the results of approximately 5,000 knee arthritis patients in our registry who were treated with their own stem cells, age is not a predictive factor. Meaning that if this graph was correct in that older age impacted the number of stem cells and that this impacted outcome, we would see clear age-related effects in the data (i.e., older patients have poorer outcomes). We don’t see that in our data.
“We can literally regenerate any cell in the body…”
Yikes! First, the type of stem cells obtained from amniotic tissues (ASCs, or amniotic stem cells) can’t turn into any cell in the human body, and in this regard, they have more in common with adult stem cells (pluripotent/multipotent) than embryonic stem cells (totipotent). In addition, the cells are dead, so dead cells can’t turn into other tissues.
“The Stem Cell Institute of America pricing structure was designed to allow the patient to receive the number of injections they actually need. While on the road, we utilized many different pricing structures, including $2000 per injection, to see what would motivate the attendees to purchase what they actually needed. What we found was, when the price was low, the patient chose an average of one injection. Their mentality was, I will try one, see how it goes and get back to you. Conversely, when we used a moderate pricing structure and gave big discounts for buying multiple areas, the patient actually bought the number of areas they needed treatment for, with this pricing structure, we averaged 2.5 injections. The value of our pricing structure is a 1.5 increase in the number of injections that new patients paid for!”
Wow! This speaks for itself. SCIA seems to have adjusted its pricing to get you to buy more product from them!
“We have researched all the top brands and have also been able to negotiate the best prices because of our group purchasing power. Your competitors can never use or super concentrated product because it is 2-4X more expensive that what they are currently using. That means that for their patient to get the same apples to apples amount of product, the patient would need 2-4 injections. So, even if they sold their injections for $2500, their patients would need to spend $5,000 to $10,000 at that office to get the same outcome as our offices do. That gives you a drastic competitive edge! The good news for us, is that our product pricing is lower than what your competitors are paying for their less concentrated product. This results in our clients paying 30-50% less for the Amniotic tissue used in the injections.”
Where to begin? SCIA has no credible clinical data in real patients comparing their outcomes with their dead amniotic stem cell product to outcomes with other dead amniotic stem cell products. Hence, any conjecture above appears to be related to claims that the amniotic product it uses has more “stem cells.” The product they use is SurForce, which is discussed later in the article. I have already blogged that the stem cell viability claims in SurForce are highly suspect; hence, the SCIA claims of being able to get better outcomes are based on a house of cards built on a house of cards.
“7. How long do the injections last? When will they need another one?
Physiologically, once a joint regenerates then it will only degenerate as a normal joint would unless it is impacted with some type of trauma. More to the point we find that one injection usually is sufficient for the patient.”
This is an insane statement given what’s been published about stem cell use in degenerative joints. There is not a shred of credible published data showing that injecting an amniotic tissue product regenerates a joint like new, which is what’s being described here. In fact, I was the first person on earth to inject living, culture-expanded mesenchymal stem cells into severely degenerated knee joints, and there is no evidence that I or anyone else have ever regrown a severely degenerated joint like new. Nor have the physicians who use these dead-cell amniotic products reported this happening. So this is just fabricated from thin air.
Interestingly, the sales rep for this product (SurForce) states that his experience is that the product doesn’t do well in knees with severe arthritis, one of the biggest markets being gone after by SCIA. In addition, he’s quoting duration of effects from 3–18 months, but Dr. Detelich is claiming that the product is regrowing brand-new joints! Press play above to listen to the sales rep for the product.
The upshot? There isn’t much about the SCIA sales pitch that’s verifiably true. Given the testing of amniotic products that has been done, it’s highly unlikely that the SurForce amniotic tissue product that they’re using has any viable and functional stem cells. Statements from the company president like the one that SCIA is regrowing new joints are pure hogwash even when more advanced and viable stem cell therapies are used (let alone dead stem cell therapies). Might some patients improve? Sure, this is a weak PRP-like growth factor (GF) shot; some patients may improve with GF shots. The improvement described by the sales rep for SurForce is pretty typical for the average platelet rich plasma (PRP) GF shot into joints with arthritis, not of a stem cell injection.
How could a chiropractor with no advanced biology background start a stem cell company in the first place? How could he be making complex claims about how a product works miracles without any clinical data to back it up? I think Dr. Detelich’s past says it all.