As I often say, sometimes you just can't make this stuff up. Yesterday I got an e-mail from a patient activist who thanked me for exposing the rampant chiro stem cell scams sweeping the nation. He also sent me recordings of an umbilical cord sales pitch that blew me away. Let me explain.
The single biggest growth area in stem cell fraud over the past few years has been chiropractors that hire a midlevel provider, like a nurse, or hire a physician with the wrong (and cheapest) skillset to inject magic amniotic and umbilical cord stem cells. We exposed one such chain in our video below, but since then many, many more have cropped up. Here's a quick video to get you oriented on how this scam works:
The product that was used in this patient fraud case was sold by Liveyon. This is a company that claims to sell umbilical cord stem cells. Are there really stem cells in this stuff? See my video below:
I'm a busy doctor. This week, since I lectured at Stanford, Thursday was a day when everyone wanted a piece. Lot's of phone conferences, new patients, follow-ups, procedures, and even an admin meeting. Nonstop from the time I got into the office until I left. In the middle of this busy day came an e-mail out of the blue. It began like this:
"Dear Dr. Centeno,
My family is very grateful for your Regenexx Blog, informational and well done videos and your straight forward, no-nonsense scientific explanations that are easily understood and digested by anyone! As a matter of fact, your article, “Amniotic and Cord Blood Bait and Switch,” is the key piece that helped our family understand that we had been duped! Your article described exactly what happened to us.
After $30K+ spent between myself, my husband and my father-in-law and no results and the fact that my father-in-law had a severe leg and foot infection shortly after receiving the 2nd IV of the now FDA Recalled product, Liveyon by Genetech, I began to search for answers as to why the purported “stem cell therapy” did not work for anyone in our family. I found your Regenexx Blog and read your articles and listened to your videos to learn how to discern the differences between bone marrow aspirate, adipose, PRP and the HCTP’s that are being sold to people under the claim that they are actual living stem cells, these products often referred to as “stem cell therapy.”
This was really interesting. This patient had turned into an activist based on my blogs exposing the chiro stem cell scams. He had included texts back and forth between him and the chiropractor and the MD that had scammed him, recorded a phone call with a Liveyon sales rep, and even recorded the chiro selling the magic pixie dust. He even has a website: http://www.avoidthestemcellscam.com/.
The patient went on: "While we are all 3 disabled, service connected veterans, my father-in-law is elderly. The DC told him that he needed 2 slow-push IV’s to heal his ulcerative colitis, diabetes and memory issues. Shortly thereafter, not only did he have a severe leg and foot infection requiring stints and a toe amputation, but he had also suffered a GI rupture requiring emergency surgery and had to have a pacemaker to recover from atrial fib…The DC and MD told us that Liveyon 'homes' into where the damage is greatest and will heal damaged nerves and tissue, vertebrae, joints, arthritis and literally any problems that we had ortho/neuro and the DC said that we both needed trigger point or blind injections along the para spinals and into my knee and hip. I realize now how simply obvious all this is, including medical advice given by a DC and orthopedic injections given by an internist MD who had no orthopedic experience. At the time, their sales job was difficult to see as the DC invited us to his beachfront home to seal the deal with more miraculous 'mirrored and matched' stories about his spine being it worse shape than either of ours and that is how he got into the 'stem cell therapy' business."
I listened intently to the audio of the recording of the chiro and the Liveyon sales rep. First, mesenchymal stem cells given IV will not "home" to these areas, but, in fact, undergo a pulmonary first pass effect (they end up in the lungs). See my video below:
Also, amazingly, the sales rep, who thought the patient was a medical provider who wanted to add Liveyon to his practice, states that the product offers 30 million "stem cells" per vial. Let's dig into this false claim next.
As I have blogged before, Liveyon frequently advertises that its products have many live, young, and viable mesenchymal stem cells (MSCs). However, Liveyon is an umbilical cord product and the issue is that umbilical cord blood is notoriously MSC poor. To understand the research behind this, see my video below:
So if Liveyon has any MSCs, they are very few in number. In fact, they likely represent much fewer than 1% of the total cells in the blood. Liveyon has traditionally sold its products in a 30 million cell vial. This is actually a total nucleated cell count number of the cells that go into the vial. Talking to the Liveyon founder on the phone this summer, he admitted that, at most, there would be a few thousand MSCs in one of these vials. Then you multiply that by the fraction that are alive, viable, and functional, which is zero. Don't take my word for that, listen to Dr. Lisa Fortier from Cornell who tested multiple amnio and umbilical cord products and found them as dead as we did:
So the 30 million young stem cells? That number wasn't right even if all of the cells were alive; in fact, it wasn't even close. It was off by 10,000 times! Then you add in the fact that these products are dead cell tissues, and the scam begins.
The patient also sent a recording that he made while speaking to who he represents is a sales rep for Liveyon and pretending he wanted to open a clinic or use the product. Since I didn't record it and have no idea where it was recorded, I listened last night for you, and here's what I heard. Some of this is paraphrasing and some of this is exactly what was said. What's being described is a neuropathy treatment program with stem cells that uses Liveyon as the centerpiece.
Sales Rep: This is a neuropathy treatment program. We pretreat the area with a stem cell signaling electrical device. We perform a few pretreatments, and then we inject the mesenchymal stem cells from Liveyon and they attach to red blood cells. The cells are immune privileged; there is no immune response. They rapidly proliferate after reinjection at 90 doublings (he used the term regenerations). Then we post-treat with 3–5 treatments. The patient is in treatment for 30 days, and then we bring them back and can do nerve biopsies on them and show that the nerves regenerate.
Patient: We're up in the Gainsville area of Florida. Are these cells live and viable?
Sales Rep: You can get them from bone marrow extraction, which is super painful. The problem is that those cells are old. It works, but it's painful. The next is adipose. What they have found is that adipose tissues don't contain stem cells. However, it's the umbilical cord stem cells that are brand new and do well in almost any host.
Patient: What's the actual cost per patient?
Sales Rep: We use precision-based marketing. [The sales rep] doesn't know if this is a doctor or an entrepreneur he's speaking to. We also use perception-based marketing. Then we use position-based statements to qualify them. As long as you put all of the steps in place, it works. We work with an exclusive ad agency that does all of your marketing for you. Let's say you're starting a new practice, we can set you set up in six weeks.
There are initially two meetings at 45 minutes each. We can make your office a cash-rich environment. We teach you how to close patients. We train your staff. We fly in on a Sunday, will be there for two hours, do a dress rehearsal, just like you were putting on a play.
On Monday, you have your consultations; we teach a three- to four-day work week. Work less, delegate more; there is a high profitability margin. As long as you have enough bodies coming in…The patients are so eager and willing, and they close on day one (of the treatment program being described). By Tuesday, you will have closed at least 10–20 K in the bank. By Wednesday or Thursday, my average on the low end, 25 K for the week. On the high end 65–70 K the first week. By the time you're rounding the third week, you're in six figures. Doesn't matter what area you're in, poor or rich, they will find a way to pay. We have financing…Even the poor people and retired will be able to do our financing.
Whether you're a doctor or an entrepreneur…you will have about 30 K overhead and make several hundred thousand a month. You will make everything back in 30 days. I've done it all over the country. You're basically untouchable. You're going to be able to do something that no one else can do because if they want to do stem cells, they have to work with us.
Patient: Are there any proven case studies?
Sales Rep: It's a little bit of both. Yes, it is perception driven. This has a very high success rate. Because of the way of the government is structured, it's the wild wild west. The reality is that they (the patients) don't care. The purpose of the day 1 (treatment) is to get them to want the care. Anytime anybody asks me about the cost or insurance, I table the answers. Once we get them to the second day, they want it and they don't care what it costs. I talk to them (the patients) like they're five years old.
Patient: On a per patient basis, what is the cost of the stem cells?
Sales Rep: We have two different programs. I teach packaging. Patients are buying the package deal. For a stem cell program, the cost is 6–7 K. Liveyon has mesenchymal stem cells. They sell 5 M, 10 M, and 30 M stem cell vials. There is a high percentage of mesenchymal stem cells in a 30 M vial. If someone comes in with neuropathy, you're going to inject 30 million, 15 in each leg. The demographic you're going to be working with, you will find that they have resources. They have credit cards, savings, retirement—they'll figure it out. They might have a shoulder and knee, so you can upcharge. For a 10 M vial, it is $1,500 and for a 30 M vial it's $1,800. The FDA requires that the use of stem cells all be documented. If there is a problem, the FDA requires tracking; those instances are so rare. Liveyon overnights it to you on dry ice; you warm into your hand.
Patient: What about mixing it with PRP?
Sales Rep: I'm not the guy to answer that, I would put you in touch with the guys at Liveyon. The sky is the limit in this realm. You're going to be the only one doing it in your area. We just took two of the most powerful regenerative medicine technologies and combined them. You want to create the most revolutionary neuropathy program in your area.
Patient: What about being FDA approved?
Sales Rep: PRP is the only one that is FDA approved. The patients sign a waiver. So we have no legal issues with this…
The FDA is cracking down on people who are doing adipose. Adipose tissue does not have stem cells in it, so they're cracking down. There are a lot of doctors doing IV stem cell therapy; you can do that as long as you don't advertise for it. The results are phenomenal for all sorts of diseases.
Patient: Sounds like Liveyon has got a great product. Where do they get their products from?
Sales Rep: Liveyon's screening process involves stripping the umbilical cord of all of its red blood cells. So there can be no rejection or infection. I'm good at making doctors money. I can help you make money.
Yikes! A few comments. As I said, there are no live and functional cells in umbilical cord blood products being sold, which we have confirmed and now Lisa Fortier's lab at Cornell has also confirmed. Second, mesenchymal stem cells, if there were any alive and functional ones in this product (which is highly unlikely), generally don't work by attaching to red blood cells. Dead cells don't proliferate in the body, and if these cells were undergoing 90 doublings, that would be a serious safety risk. As an example, the sales rep states that Liveyon sells a 30 million cell vial with a high percentage of stem cells. If we use the number 20% as very high (it would really be far less than 1% if any survived), then that's 6 M MSCs. One doubling of the cells would produce 12 million, and two would be 24, three at 48, four at 96, five at 192, six at 384, seven at 768 million…You get the idea. Cell doublings add up very fast, like compound interest at the bank. So at 90 doublings, you would likely have more stem cells in your body than all the cells in your body (37 trillion).
What really hit me like a ton of bricks listening to this sales pitch was that at no time is this a medical discussion. As far as the sales rep knows, he's talking to an investor who wants to open a clinic. There is no qualification of the doctor they will use, nor is it discussed how many patients won't be candidates. This is simply a sales system no different than selling mortgages or timeshares.
The patients went on the Today show this morning. There, of course, was a chiro, who was the main culprit here, and an MD; both are now being sued by this family. Maybe this will finally begin to give providers some pause when they get the sales pitch that using stem cells is as easy as selling timeshares.
The upshot? Sometimes you can't make this stuff up. It's amazing to me that Liveyon is still going strong after its bacterial contamination fiasco and getting an FDA letter. However, I see that now the focus is on teaching providers how to sell patients.
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.…