A Regulators Guide to Taking Down the Stem Cell Wild West

I often write about the “Stem Cell Wild West”, which is made up of clinics with little expertise who usually purchase off the shelf, dead birth tissue products, claim that these contain millions of stem cells in aggressive “buy now and save” seminars, and then charge the elderly way too much for way too little. This is getting attention right now form a host of regulators including congress who wrote a letter to FDA last week. However, if regulators really want to stop these clinics, the best way to do that is to go after the accomplices that make it all possible. Let me explain.

The Sherman Tank

I love history and one of the more interesting stories is how the Sherman tank, used primarily during WWII, got its name. It was named after William Tecumseh Sherman, a civil war general. Sherman figured out that the best way to stop the confederacy was to destroy their infrastructure. Hence, as he moved through Georgia and South Carolina, he burnt crops, destroyed railroad tracks, and disabled plantations. What Sherman did during the civil war is what regulators need to do today to stop the Stem Cell Wild West.

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The Collaborators

I created the diagram below to show regulators how many different companies are involved in facilitating bad stem cell clinics. Let’s go through some of these:

Lead Generation Companies

I found this yesterday which about sums up the problem with lead generation companies:

Yes, this website is real. A company with experience in getting leads for roofers is now involved in getting leads for stem cell clinics? How does having experience in whether the customer wants asphalt or slate transfer into the complex scientific, clinical, and regulatory world of stem cells that involves state medical boards, the FTC, and FDA? Your guess is as good as mine.

These companies create marketing campaigns to generate butts in seats in seminars and clinics. Without their marketing expertise, clinics won’t have patients. Hence, one target for regulators should be lead generation companies.

3rd Party Seminar Companies

We’re beginning to see vendors who will host seminars on behalf of clinics. These are high-pressure sales events that target the elderly, often with claims of selling them stem cell treatments that involve millions of live and young stem cells from amniotic or umbilical cord sources. These seminars have more in common with those selling timeshares or penny stocks than they do real hospital-based seminars talking about medical care options.

While many clinics will put these on themselves, we’re now seeing third party companies who do this work. I documented one in Canada working with a Montana clinic and ProPublica confirmed another. We’ve also seen birth tissue manufacturers holding seminars to generate leads and then selling those leads to physicians. So this should be another target for regulators.

Orthopedic Sales Reps

If the manufactures that I describe below are the drug king-pins that make the illicit substances, the sales reps are the drug dealers. In particular, the fraud is often blown up to bigger levels by the orthopedic sales rep. There are professional salespeople that sell all sorts of orthopedic equipment, drugs, and devices. They are usually honest and hardworking people, but they are salespeople. Meaning, what you hear as a doctor is often designed to get you to buy. So any physician should take what he or she hears with a big grain of salt.

However, when it comes to birth tissue products, dishonest sales reps often expand on the myth that these vials have millions of stem cells. Why? Because this allows them to fetch top dollar from doctors. After all, who is going to pay more than the price of gold for a bottle of amniotic fluid that’s half baby urine? Or for a bottle of jelly from an umbilical cord. No one. Hence, these sales reps, who often break the law by placing these claims in writing in emails and messages sent to doctors, should be a big target for regulators.

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Independent Testing Labs

Many of these clinics rely on reports produced by a lab that claims to show that the product has millions of stem cells. However, any credible scientist can look at these tests and show that you can’t draw this conclusion from the data presented. I’ve also found at least one scenario where someone altered the conclusion of a university lab to make it appear that the scientist supported that this umbilical cord product had millions of live stem cells. 

Birth Tissue Manufacturers

If the sales reps are the drug dealers, then the Pablo Escobars of the birth tissues world are the companies that manufacture the birth tissues. These companies flagrantly violate the law every day by registering their product as a non-viable tissue and then claiming to be selling stem cell products, often on their own websites and social media posts. Of all of the facilitators of the scam clinics, this is the kingpin. Most clinics would go out of business if the birth tissues manufacturers claiming live stem cells were shut down.

The upshot? Most outside observers like regulators only see the clinics and the patients. What they often miss is a complex web of companies that have sprung up to assist clinicians in fraud. Take out these companies and the clinics will have a hard time operating.

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

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NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. All content provided in this blog, website, or any linked materials, including text, graphics, images, patient profiles, outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you.

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