Is this Fraud? Chiro Clinics and Cord “Stem Cells”
I was on a local radio show this week and a woman called in and claimed that she had been defrauded by a local chiropractic clinic. She paid big bucks for what she was told were "millions of young stem cells" injected intravenously. As I will show you this morning, as a medical expert in this area, I can show you that she is more likely than not the victim of consumer fraud. Let me explain.
The Problem of the Chiro Clinic Bait and Switch
I've blogged extensively about how chiropractic, acupuncture, naturopathic, and some physician clinics are defrauding patients by claiming to inject millions of live and young stem cells from amniotic fluid or cord blood (or other products). The problem is that none of these 361-registered tissue products has any significant number of live stem cells. We have tested many in our advanced lab, and we're now having a university lab test a whole new batch. For more info on this type of bait and switch, see my video below:Request a Regenexx Appointment
A Radio Show and an Angry Patient
There is a nationally known Denver-based consumer advocate, Tom Martino, who hosts a daily radio call-in show for people who believe they have been scammed. Tom covers a wide variety of issues, and I helped him reveal a local healthcare scam involving dead stem cell injections being performed by local chiropractors. As a result, I became a regular on his show and was on air on Monday when this patient called. She was seen by Atlas Medical Center in Colorado Springs. This is the "contract" they gave her:
This IV "stem cell" injection didn't do anything to help her, and she had tried calling the clinic, got frustrated, and finally called Tom Martino's show. I told the staff of Tom's show that I would dig deeper into all of this and create a blog with my findings.
Can This Clinic Prove There Are 30 Million "Stem Cells" in the Product They Used?
Any reasonable person reading the above sheet of paper would believe that the clinic is claiming that it will inject 30 million stem cells in exchange for $5,400. In addition, on the clinic's website we see this:
"OUR REGENERATIVE MEDICINE PRODUCT
Liveyon’s FDA approved regenerative medicine product is derived from Umbilical Cord Tissue Donations. Our product contains mesenchymal stem cells (MSCs) and is rich in growth factors from umbilical cord tissue."
What proof is there that this patient is getting injected with 30 million mesenchymal stem cells (MSCs) derived from cord blood? Given that Liveyon is a commercially available tissue product, we can vet that claim.
What Is Liveyon?
The Liveyon website is regrettably down right now because it voluntarily pulled itself off the market due to suspected bacterial contamination of samples. Its website claims it's launching a new product. However, this treatment took place when Liveyon was very much an active company selling vials of cord blood. So let's explore the evidence that this manufacturer has produced to date that would support this claim.
I have blogged extensively in the past on Liveyon. In fact, this video shows my conclusions on their claims:
In summary, here's what I found:
1. The simple live/dead stains performed by the company demonstrate awful initial rates of cell survival of 50–70%. Why is this a problem? Survival rates this low likely mean that the cells are dying out of the bottle and will soon be dead.
2. The company tried to find mesenchymal stem cells in their sample by using the wrong cell markers for these cells. There are a standard set of markers in the scientific literature that must be present and must be absent, and Liveyon's testing didn't use the markers that would be required to identify a single MSC, let alone 30 million MSCs.
3. Liveyon failed to perform the requisite additional culture-based tests to verify it had any living stem cells. These are based on strict scientific guidelines produced by the Foundation for the Accreditation of Cellular Therapy (FACT).
4. The growth factors the company claims are in this product are found at much lower levels than would likely be present in this woman's platelet-rich plasma made from her own blood.
Hence, Liveyon has produced no credible science that would back up the claim that it has 30 million live and viable stem cells in its product.
Can We Dig Even Deeper on Liveyon?
Given that Liveyon has no FDA approval (which the Atlas Medical Clinic website erroneously says it does have), but instead only has a quickie 45-minute free online registration of its product, it can not legally claim it has any viable cells at all. In addition, please note that because of this registration without a formal FDA approval, there is no FDA independent testing of any of these claims.
I reached out to the owner and CEO of Liveyon, John Kosolcharoen, to get his take on Atlas Medical Clinic's claim. Here's what he said by phone:
- Liveyon does not endorse their product to be injected IV to treat these conditions. In fact, it is having practitioners sign agreements that they will not use it IV.
- The 30 million number would be the total nucleated cells in the product when they were put in the bottle. It's is NOT a live stem cell count. He felt that if there were a few thousand mesenchymal stem cells in the product that were living at the clinic after thawing, that would be a high number.
What's the Difference Between Total Cells and Stem Cells?
There's a HUGE difference between the total number of cells in a vial and the stem cell content. Why? First, cord blood is MSC poor. Meaning that we have several research studies that have been unable to isolate any MSCs from most fresh umbilical cords. Second, even if MSCs were present, they would be a TINY fraction of the total number of cells in the fresh cord blood. Hence, the CEO's estimates of, at most, a few thousand in the vial would be very high. At the end of the day, as I have discussed above, there are likely zero viable and functional stem cells in any Liveyon product.
Can the Clinic Prove There Is Any Research Whatsoever That Would Support the Use of IV Cord Blood Injections to Help with "Lung Capacity," "Vision," "Arthritis," and "Rejuvenation"?
The clinic wrote down on the form what they were treating. So do we have any published research data showing that an IV infusion of cord blood will improve your lung capacity, vision, or arthritis or rejuvenate your body? No, we have no such published research. In fact, the FTC just went after a stem cell clinic in California that made similar claims.
Trying to Get a Comment from the Clinic for This Blog
I wanted the clinic to be able to defend why it made this claim. Hence, I called the clinic, trying to contact the physician they list on the website. I was told by the receptionist that the physician listed on the website only comes in when there is an "overflow of patients." After speaking with the receptionist a second time, it was clear to me that the physician listed was more of a figurehead and that the treatment was performed by the nurse practitioner. I then asked to speak to the nurse practitioner numerous times throughout the day but got no calls back. I tried to contact the chiropractor who owns the clinic, a Dr. Carlson, but he was not available.
So we have a chiropractor who employs a physician as a "figurehead" and who runs cord blood injections through his clinic claiming that they can treat a panoply of diseases. In this case, we have a written "contract" that states that the treatment is to increase lung capacity, improve vision, treat arthritis, and rejuvenate her body. There is no evidence that an IV infusion of cord blood can help any of these problems, and the manufacturer of this product states that its product should not be used IV. The chiro office put in writing that this woman would get 30 million stem cells, but the owner of Liveyon states that this number is not a stem cell count, but a total cell count of the product (what they put in the bottle before freezing, shipping, and thawing). He stated that, AT MOST, there were a few thousand mesenchymal stem cells in this sample. I would state that based on the published research and our own lab investigation of similar products, there were zero viable and functional stem cells in the Liveyon product used here.
So Is This Healthcare Fraud?
The legal dictionary says: "Health care fraud is a crime that involves misrepresenting information, concealing information, or deceiving a person or entity in order to receive benefits, or to make a financial profit."
So here's what we have:
1. Misrepresenting Information
A. The clinic clearly misrepresented what it was injecting. A reasonable person would read this sheet of paper and conclude that they were getting 30 million live and functional stem cells injected IV. The Liveyon company owner whom I spoke with today stated that this claim is not factually accurate.
B. The clinic website states that this therapy is "FDA Approved." The product is not FDA approved but only has a 45-minute quickie registration, meaning the FDA never "approved" anything with regard to Liveyon. In addition, the only use for cord blood that is FDA approved on the agency website is treating blood-borne cancers and not any of the listed items on this contract. In fact, the FDA warns of this type of cord blood stem cell fraud, stating:
“Because cord blood contains stem cells, there have been stem cell fraud cases related to cord blood,” says Wonnacott. “Consumers may think that stem cells can cure any disease, but science doesn’t show this to be the case. Patients should be skeptical if cord blood is being promoted for uses other than blood stem cell regeneration.”
2. Deceiving a Person
This woman believed that these were effective treatments, which is why she ponied up $5,400. There is no published data either by the clinic, the manufacturer, or listed in the US National Library of Medicine that shows that cord blood as used here is effective for these diseases or problems. See above.
3. To Make a Financial Profit:
The cost of a 30 million cell vial of Liveyon is approximately one thousand dollars. The cost of starting and running an IV, including the nurse's time, is at most a few hundred dollars. So a substantial profit was made here.
So looking at the facts as I have them today, I would say that this act meets the definition of healthcare fraud. I will, of course, defer to legal experts as I have recommended that this woman file a complaint with the Colorado State Attorney General's office.
The upshot? The craziest thing about this is that we have hundreds of chiro, acupuncture, naturopathy, and age-management clinics all over the country running this scam on a daily basis, convincing consumers to hand over hard-earned cash by deceiving them. My biggest concern is that while there are legitimate uses of live stem cell therapy derived from the patient, these scams will destroy consumer confidence in legitimate therapies.