One of the most interesting things about the stem cell wild west is that new business models are being hatched every day. These will make FDA enforcement very complicated. A brand new one is what I’ll call the “Circus Barker”. This is how I would classify the “Regenerative Warrior” podcast after an extensive review of both the science presented, and the accuracy of information sent to me.
The Circus Barker
Ken Burns has an excellent new documentary on the Circus, well worth watching if you get a chance. In that film, the idea of a Circus Barker is introduced. The purpose of this job was to attract patrons to an event, usually by conducting a small free show outside the big tent.
The stem cell wild west has morphed into all sorts of new business ideas. One is a rejiggering of chiropractic practice consultants from their usual role to that of selling chiropractors medical services like stem cell procedures. This podcast is a new type of sales pitch offering free advice to chiropractors (much like a Circus Barker offers a small free show). It seems to be monetized through sponsors, in this case, another chiropractor selling a stem cell product. Let me explain.
The Regenerative Warrior Podcast
We’re met with the image above of Dr. Ross Carter. Who is this? On Linkedin, we find that he states, “I help medical professionals, including orthopedists, primary care, pain management, and chiropractors market, manage, and magnify their regenerative medicine practice.” He doesn’t list his educational experience on his profile, but through other searches, I found out that he is a chiropractor in Georgia. He does state on his profile page that he did a fellowship in “Stem Cell Therapy” through the A4M. However, as I have shown before, this isn’t an actual fellowship, but a series of for-profit courses on stem cells.
The episode I found was “Comparing Different Stem Cell Types” in which, a Dr. Korth (a chiropractor) discusses a Wharton’s Jelly product that can be bought by sending a text to the Regenerative Warrior’s sales center. In fact, periodically throughout the 25-minute episode, we hear Ross saying, “I talk to the top experts to show doctors how to market, manage, and magnify their practice to help more people and make more money.” You are also prompted to text your name to and request for information on the product being featured. In fact, you’re told that you can get discounted pricing on this stem cell product.
Now, hopefully, you see why I used the Circus Barker analogy, as the purpose of this podcast episode seems to be to sell this product. More importantly, in order to review the podcast in general, I vetted what was being presented. For example, how accurate is the information in the Podcast itself? As I dug deeper, I would find all sorts of surprises.
Dr. Korth’s Stem Cell Product
The first thing I noticed about Dr. Korth’s sales pitch for his Wharton’s Jelly stem cell product was his inaccurate interpretation of the FDA’s regulations. He basically focuses on the homologous use portion of the guidelines and forgets another critical part. Let me explain.
Homologous use per the FDA means: “the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.” Dr. Korth says in the podcast:
“So the FDA has defined umbilical cord tissue as providing cushioning and viscosity for the umbilical artery and vein, so as long as a provider is using umbilical cord tissue to provide cushioning and viscosity they’re going to be compliant. So an example of that is that if you have an osteoarthritic joint and you want to provide cushioning then obviously umbilical cord tissue is a great cushion, right?
Ok, let’s unpack this statement. First, to decide whether Dr. Korth is selling a tissue which only requires a free 45-minute online 361 registration or an unapproved drug which requires FDA approval including years of clinical trials, we’ll use a two-part test. First, is the homologous use argument he makes and next will be his claim of live stem cells in the product.
On homologous use, is injecting Wharton’s Jelly into an arthritic knee a homologous use as defined by FDA? Wharton’s Jelly is the stuff that gives the umbilical cord it’s stiffness and it does protect the umbilical artery and vein. So it does provide a cushioning effect in the umbilical cord as described. It could also provide a cushioning effect in the knee. So on this test, the product may pass muster as a registered tissue that doesn’t require FDA approval like a drug.
However, the FDA also uses the “objective intent” of the manufacturer. This is also linked to the intended use. This is where things get sticky for Dr. Korth’s product. For example, how the product is described as being used is critical. For example, charcoal sold as fuel it is not FDA-regulated, but when charcoal is intended for use as an emergency treatment for poisoning, it is a drug subject to FDA regulation. Meaning, what you say your product is being used for is a big deal. This brings us to the claim of live cells in the product. In this case, Dr. Korth talks about using the product for its stem cell content.
The FDA’s 1271 regulations in 1271.10(a)(4)(i) state that the product can’t be registered as a tissue if the substance is from another human, has a systemic effect and is dependent on the metabolic activity of living cells for its primary function. This is where Dr. Korth’s analysis breaks down. By spending much time in the podcast describing that his product has many living mesenchymal stem cells, he is moving his product from a tissue to a drug. To learn more, watch my video below:
The FDA has defined this claim of live stem cells in birth products very narrowly in many Warning Letters, such as this one concerning Liveyon’s umbilical cord product. Here the FDA stated:
“In addition, the umbilical cord blood products fail to meet the criterion set forth in 21 CFR 1271.10(a)(4). Specifically, the products, manufactured from donated umbilical cord blood, are dependent on the metabolic activity of living cells for their primary function and are not for autologous use, allogeneic use in a first-degree or second-degree blood relative, or reproductive use.”
So, based on this analysis, Dr. Korth is selling an unapproved drug product through the Regenerative Warrior podcast.
Does the Product Really Have Stem Cells?
First, realize that the FDA determines whether something is a drug solely based on the claims of the manufacturer. So claiming live stem cells in this WJ product is more than enough to qualify it as an unapproved drug product. However, it doesn’t matter to the FDA whether it really has live stem cells or not, as it’s the claim that determines how it regulates. However, that could be important to patients, so let’s dig in there.
So does this product have loads of stem cells? First, Dr. Korth makes some statements about the stem cell content of his Wharton’s Jelly (WJ) product versus bone marrow that can’t be supported. Fresh Wharton’s Jelly taken directly from a live birth does have has some stem cells. How many stem cells are in there? The scientific literature generally says about the same amount as you would find in the bone marrow to maybe a bit more. However, Dr. Korth claims that fully 25-35% of all the cells in the WJ are mesenchymal stem cells! In fact, using his math, we would expect to find thousands of times more stem cells in his WJ product than could be found in the bone marrow. Is that true?
Sending a Text to Buy My Vial of Stem Cells
The podcast said that you could send a text to get information on buying these stem cells as well as a white paper. The white paper sent to me was authored by Rooster Bio, which is an impressive cell production and testing company. I and a colleague were dumbfounded that they could be involved in this sales pitch. I figured something wasn’t right, so I reached out the founder of that company who was also dumbfounded that their report was part of this sales pitch. The company founder sent this statement via email:
“We are not associated with Regenerative Warrior or Doctor Ross Carter, and am surprised that a testing report that we authored last year is being used in his marketing using our trademarks. RoosterBio did perform a small service contract last year applying our standard hMSC release assays to cells that were sent to us by a company (not Ross Carter), but we did not give permission for this content, or the RoosterBio name, to be used in any marketing materials.”
The founder also couldn’t confirm that what they received was a WJ commercial tissue product and stated that they believed that they were testing was an FDA drug product candidate.
The main conclusion of the Rooster Bio report was this: “Fresh Wharton Jelly (WJ) isolates had few adherent cells as expected (D1-D3) and comparable to other sources of mesenchymal stem cells (MSC) such as bone marrow and adipose tissue.” Huh? I thought that Dr. Korth said that his Wharton’s Jelly product has thousands of times more stem cells than bone marrow?
Interestingly, if Rooster Bio was sent a tissue product, they would be the sole investigator ever to find viable cells in a Wharton’s Jelly product that would survive to be able to culture expand. So far, our research lab, Lisa Fortier’s at Cornell, and the CSU Translational Medicine Institute have all failed to find any live stem cells in commercially available WJ products. So what could be different?
- We have no idea what Rooster bio was sent. Meaning, if it was a commercially available product, why didn’t they note the name of the product and the lot number in the report?
- Rooster Bio thawed these cells like they were a stem cell drug sample with controlled rate thawing, which is also what we would do in testing culture expanded stem cells. However, that’s not how they are thawed in the clinic. Faster “in the hand” bedside thaws would usually kill more cells.
- Rooster bio plated these cells in culture with several media designed to supercharge growth.
Assuring the Accuracy of the Information Presented on the Podcast
As you can see, I can’t review the quality of the Regenerative Warrior podcast without also first reviewing the quality of the science and other information presented. That, based on the review of this single podcast, was poor. Meaning that as a physician-scientist in this area I would have known enough to cut Dr. Korth off when he began stating that 25%+ of the cells in Wharton’s jelly were stem cells. In addition, as I have shown, the mere claim of stem cells in this product means that the tissue being sold is an unapproved drug product and not a registered tissue as claimed. Hence, we have lots of inaccurate information presented in this episode.
Which gets back to the basic issue here with the Regenerative Warrior podcast. Is the interviewer, Dr. Ross Carter, who is a chiropractor, a regenerative medicine expert? To earn that title, he would have to have scientific publications in this area. I can find none.
The upshot? My overall review of the Regenerative Warrior podcast, based on this episode on stem cell types is not favorable. Why? The information presented wasn’t accurate and verifiable. In fact, trying to verify it caused the founder of the testing company to appropriately distance himself from this sales pitch. Hence, in my humble opinion as an actual expert in this space, this podcast seems more like a Circus Barker selling a product, than actual vetted scientific or medical information.