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“Stem Cell Wild West” websites are a dime a dozen. One of the more interesting claims out there is of being “The World’s Best” or “The World’s Most Advanced”. Let’s explore that this morning.

Lots of Blogs

Before I get started this morning, let’s take a second to reflect. As of this blog, I have published 3,410 blogs. Yikes! Think about that. Each one now takes about 3-4 hours to write. Early on they were shorter and only took about an hour. So if we use 3 hours as the weighted average, that’s about 10,200 hours. That means 255 40-hour weeks or a grand total of about 5-years of full-time work!

The Stem Cell Wild West

While the phrase “Stem Cell Wild West” has now come into more common use, I’m pretty sure I originated its use right here on this blog sometime in early 2016. If someone wants to research that and email me if they can find an earlier use, that would be fun to know.

The stem cell wild west, in my definition and IMHO, is the stuff that just doesn’t usually happen in medicine but happens in the world of stem cell clinics. This can fit into a number of categories, but here are a few of the common ones:

1. FDA non-compliant – For example, using culture-expanded, enzyme digested, or allogeneic “stem cells”.
2. Wild Promises – Physicians are usually pretty muted about what they can deliver. You often hear them use terms and phrases like “likely” or “unlikely” or “I think we can help” and less often use phrases like There’s a 100% chance I can cure you”. However, in the stem cell wild west, there are all sorts of crazy claims of efficacy and/or safety.
3. Resume Buffing – Here, some wild claim is made about the clinic. For example, we often see small strip mall chiropractic clinics rebranding themselves as an “Institute” or another common one is “World’s Best” or “World’s Most Advanced”.

The World’s Best and Most Advanced

I put all of the resume buffing on literally dozens to hundreds of stem cell clinic websites into a category I call “The World’s Best”. Since I love movies, this is the scene from Elf that makes me think of this category:

While that’s a Christmas parody of the stuff we get bombarded with about this or that being the world’s best or most advanced, it brings up an important point. While those claims outside of medicine get policed by the FTC, in medicine, they are first policed by state professional boards. Many state boards have strict rules on making sure that what you write in an ad or on a website is able to be proven and/or substantiated.

I’ve blogged on examples of this claim in the past: see example 1 and, example 2. The problem is obviously any claim like this is going to be very hard to prove. So let’s explore why that’s hard to prove and learn what separates clinics in the process.

Categories

Let’s explore what would allow a clinic to get into specific categories along the way to “World’s Best”. For example, if I use the phrase, “World’s Most Advanced Regenerative Medicine”, how would I prove that to a medical board? Let’s start by creating some categories:

• Close Enough
• Not Close Enough
• Not Even Close

In going through what allows each clinic to qualify, we’ll learn quite a bit, so let’s dig in.

Close Enough

Let’s begin with clinics that are “close enough” Meaning that any medical board analysis would have to conclude that clinics like these were so much more advanced than their peers, that they were more likely than not to be able to use the moniker of “Most Advanced”.

Let’s look at some metrics:

• Physician Training
• Clinic
• Cell Processing
• Lab Research
• Clinical Research
• Registry
• Presentations

Let’s start with how our Colorado HQ site fits into all of this:

• Physician Training – All physician specialists are dual-trained in both fluoro-guided interventional spine and peripheral joint ultrasound-guided injections. Meaning any physician who isn’t an expert in both is not eligible to work in the clinic. Only physicians who have completed the clinic’s one-year fellowship program are eligible to work in the clinic.
• Clinic – Multiple dedicated procedure rooms with both fluoroscopy and ultrasound.
• Cell Processing – cGMP class cleanroom to process cells. No use of simple automated centrifuges. The cell processing lab is run by a dedicated lab manager and more than 100+ SOPs are strictly adhered to run the lab. Frequent sterility checks are used to maintain lab safety. Cell counting is performed on every sample and/or used for QC.
• Lab Research – The clinic has a dedicated lab capable of replicating almost any lab research that can be performed by a university. This includes things like microarray ELISA, flow cytometry, fluorescence-activated cell sorting, PCR, normoxic and hypoxic incubators, etc… A dedicated lab Ph.D. with publications in orthobiologics runs the lab research program.
• Clinical Research – A dedicated CRO-level research operation with a full-time Ph.D. research coordinator. Multiple clinical studies are being performed at any given time. The clinic publishes several original research studies a year in peer-reviewed medical journals.
• Registry – All consented patients have had their outcomes and complications tracked in a registry for going on two decades.
• Presentations – Based on everything above, the clinic’s physicians are asked to present their original research all over the world.

Finally, there’s an X-factor involved in laying claim to the “Close Enough” category of “World’s Most Advanced”. The clinic can legitimately lay claim to being the world’s first to perform specific procedures, use certain orthobiologics for specific clinical applications, etc… For our Colorado HQ, that’s using bone marrow concentrate to treat conditions like ACL tears using fluoroscopy and using platelet lysate to treat radiculopathy. In fact, there are so many treatment firsts that it would be tough to summarize them all in a paragraph.

Not Close Enough

Now let’s look at a clinic that wouldn’t be able to easily defend the claim of “The World’s Most Advanced” to a medical board:

• Physician Training – Not all physician specialists are dual-trained in both fluoro-guided interventional spine and peripheral joint ultrasound-guided injections. Meaning any physician with good skills would be qualified to work at this clinic. There is no fellowship program.
• Clinic – There may be one room with c-arm fluoroscopy or none. Most procedure rooms have ultrasound only.
• Cell Processing – There is no lab to process cells. Instead, simple automated centrifuges are used. No sterility checks are performed. There is no cell counting to establish a dose.
• Lab Research – The clinic has no lab research program.
• Clinical Research – There is no clinical research program.
• Registry – There is no registry use or if one is being used, it’s just recently been added.
• Presentations – While the physicians may be asked to help teach low-level courses, they are not asked to present their original research all over the world.

Obviously, there is no X-factor. Meaning this clinic has not been the first to perform any procedure, but has generally followed the trends rather than made them.

Not Even Close

Now lets’ look at a really problematic clinic:

• Physician Training – Physicians are generally not used, instead, mid-level providers like nurse practitioners and physician assistants generally run the show and are performing most of the procedures.
• Clinic – The clinic is generally a chiropractic site or another alternative health clinic. There may be no dedicated procedure rooms. If imaging guidance is used at all, it’s generally only ultrasound.
• Cell Processing – There is no lab to process cells. The product is usually off-the-shelf dead birth tissues falsely advertised as live stem cell therapy.
• Lab Research – The clinic has no lab research program.
• Clinical Research – There is no clinical research program.
• Registry – There is no registry use.
• Presentations – None.

The Hard Part for Consumers

Our regulatory institutions like state medical and chiropractic boards should be protecting consumers and taking down any clinic falsely advertising this way. However, that’s generally not the case. The problem for consumers is that all three of these clinic types have really fancy and pretty websites. Hence, it’s VERY HARD for an uneducated consumer to know that they’re not walking into the “Wolrd’s Most Advanced Clinic” or not really receiving “The World’s Most Advanced” treatment. However, that’s why I got up at 4 am to write this morning, so you can educate yourself on what to avoid.

The upshot? While that scene in Elf will be watched millions of times this holiday season, when you see it, reflect on the idea that we have medical clinics in the stem cell wild west that have websites that make similar “World’s Best” claims. Hence, if your friend a loved one is looking for help with a bad knee, shoulder, or back and asks you about a local clinic advertising this way, make sure that you send them this blog!

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