Stem Cell Recruitment Therapy?
One of the new trends I see out there is that amniotic products are now being branded as stem cell recruitment therapy. Today we’ll explore the concept and the company that has trademarked that term and a website involved with an ex-chiropractor previously accused of Medicare fraud. Let’s dig in.
The Genesis of the Term Stem Cell Recruitment Therapy
A few years back, sellers and resellers of birth tissues were claiming that their products had viable stem cells. Some shady ones still do. However, once we began publishing and presenting the results of our lab tests and then other university labs followed, the people selling this stuff needed a new sales angle that would still allow a cheap product to be sold for more than the price of gold. How do you do that? You come up with the idea that while the product doesn’t have functional stem cells, it’s really a “stem cell recruitment” therapy. So let’s dive deeper into this term, which bizarrely, is now trademarked.
For more information on why these products don’t have any stem cells, see my video below:Request a Regenexx Appointment
What Is Stem Cell Recruitment Therapy?
These are amniotic fluid products. The idea is supposed to be that they have growth factors and cytokines that can recruit stem cells to an area and those cells will initiate healing. The problem is that there is scant clinical evidence that this actually happens when this stuff is injected into another human.
A Shortlist of Manufacturers and Clinics Using this Term
First, let’s review a top 10 list of websites that are using this term:
- Russell Health-A medical supply company
- Memphis Stem cell Institute-Really Smith Chiropractic Clinic in Cordova, Tennesee
- Pineapple Health-An osteopathic clinic in Pheonix, Arizona.
- Louisville Bones-An osteopathic clinic in Louisville, Kentucky.
- Regenerative Revival-An anti-aging clinic in the Woodlands, Texas.
- Axness Integrative Medicine-A chiropractic clinic in Baxter, Minnesota.
- Pure Health-A chiropractic clinic in Aurora, Illinois.
- Magnolia Medical group-A chiropractic clinic in Eatonton, Georgia.
- Pain Relief Institute-A pain management physician in Glenview, Illinois.
- Revive Wellness and Rejuvenation-A chiropractic clinic in Glendale, Arizona.
Arguably, the two most interesting hits above are Russell Health and “The Pain Relief Institute”. IMHO the rest just is a collection of low-level regen med clinics.
A Trademark for a Sales Slogan, Really?
A common thread here is that a good number of these clinic websites state that the term stem cell recruitment therapy is a trademark of Russell Health. Hence, I searched the USPTO and found this Trademark applied for by Russell Health in October of this year (it hasn’t yet been assigned to an examiner):
STEM CELL RECRUITMENT THERAPY™ trademark registration is intended to cover the categories of acellular treatment service that provides a combination of growth factors, cytokines, proteins and other endogenously synthesized molecules from amniotic fluid and placental tissue to provide lubrication, restore, modulate inflammation of a human body’s own healing process, and rejuvenate human tissues; providing consultancy, advice, and information services about the development, implementation, and benefits of the aforementioned services.
So we have a trademark application that violates, IMHO, the basic principles of an FDA 361 quickie tissue registration by making claims that the product being described modulates inflammation during healing and can rejuvenate human tissues. More on that below.
What Is Russell Health?
Russell Health is a medical sales distributorship located in Chicago that lists two employees on Linkedin. The CEO is listed as Ryan Salvino, MBA. Ryan is a real estate broker turned biotech entrepreneur. He seems to be related to Kevin Salvino who is a podiatrist in Hinsdale, Illinois. That practice also offers “Stem Cell Recruitment”.
This is what greets you on the front page of the Russell Health website:
Then we see this:
Wow, the company claims right upfront that its product is “safe and effective”? Why am I blown away to see that specific claim for an amniotic tissue product that only has a quickie 45-minute tissue registration with the FDA? Because that type of registration doesn’t come with any FDA review of the product that would allow a manufacturer or reseller (like Russell Health) to make any claims about the effectiveness or safety of what they sell. To make these claims about an FDA regulated product would require years of FDA supervised clinical trials.
I called Russell Health and wanted to know what product this sales distributorship was selling. Meaning it was clear to me that Russell Health was a sales outfit and had no products that it actually manufactured. I was told that they were selling “Amnio Flow”. This appears to be the Flower orthopedics product “Amnio Flo”. To confirm, I also found this on their website:
More Q-Code Scams
So we have a sales outfit that has trademarked the term “Stem Cell Recruitment Therapy” that IMHO is making claims that are clearly not permitted by existing FDA regulations. However, more interesting is that many of the websites that use Russell’s not yet trademarked term (I assume these are Russell’s customers) also offer Medicare and other insurance reimbursements for these injections to treat problems like knee arthritis. That of course is an amniotic Medicare scam that I’ve blogged on before. To get the details of why that reimbursement is a very dangerous fiction, watch my video below:
However, one of the more interesting clinics using this trademarked term and advertising Medicare reimbursement is the Pain Relief Institute. Let’s dive down that rabbit hole.
The Pain Relief Institute
The Pain Relief Institute is a chiropractic-owned clinic in Glenview Illinois. When I initially hit one of The Pain Relief Institute websites, there was no identifying information about the location or the physicians involved. Then after a phone call to their number and extensive Google searches, I finally tracked down that this is a clinic run and owned by Shannon Patel. Cross-referencing images and websites, Shannon is the wife of Neelesh Patel, who is also listed as working at the Pain Relief Institute. This is where it gets interesting.
Neelesh Patel is an Illinois chiropractor who was caught up in a Blue Cross/Blue Shield billing fraud case. He was part of a series of “Physical Medicine Clinics” that developed sales scripts that would get Blue Cross/Blue Shield patients to agree to more care than they actually required. All of this also involved billing for services never rendered and diagnostic tests that were not needed. Patel’s employer went to prison, while Patel entered into a deferred prosecution agreement to avoid a trial that could have ended in jail time. His license to practice Chiropractic was revoked in 2014. His side of the story is here.
Are the Patels Angling to Be Involved in Yet Another Medicare Fraud Case?
Frankly, I read Dr. Patel’s version of the story and liked it, as it seemed like he got caught up in a racket and scam that his employers were running. The fact that he got a deferred sentence while his employer went to federal prison seemed to support that conclusion. However, then I found this website:
There’s so much wrong here that I needed to create a list:
- “Patient Satisfaction Rating” is a huge red flag. Why? First, there is a patient class action lawsuit ongoing against a stem cell clinic for misleading patients by using this same claim. Why? Patients believe that this “97%” number refers to those who had a long-term successful outcome due to the procedure when in fact it actually refers to people who were satisfied by clinic operations. In the meantime, note that this number is also listed as “92.5%” at the bottom of the page.
- While there is no published clinical trials data on the Flower Orthopedics product being sold to this clinic and currently covered under the umbrella of the trademarked term “Stem Cell Recruitment Therapy”, you would think from reading this page that the facts were the opposite. That everyone else was performing an experimental treatment without data but not this clinic.
- The fact that the clinic states that these procedures take only 15 minutes in my expert opinion means that instead of doing this right by precisely injecting specific damaged structures using fluoroscopy and ultrasound, these are quickie injections. For example, our procedures in peripheral joints take anywhere from a low of 40 minutes to 3 hours to perform.
- Then finally, we get to the real picadillo, which is the claim that this stuff is covered by Medicare. It’s not. Falsely submitting Medicare claims for non-covered items that are then inadvertently paid by CMS can mean federal prison time for the clinic submitting the bill.
So are the Patels angling to be caught up in yet another Medicare fraud case, this time involving stem cell recruitment therapy?
Hinsdale Foot and Ankle
This was one of the clinics offering stem cell recruitment therapy which seems to be run by the podiatrist relative of the guy running Russel Health. To see what’s happening there with insurance reimbursement, I had someone call the clinic and this is what they learned:
- At the beginning of December, BlueCross and Medicare decided this treatment was experimental and they are no longer covering these products to treat pain. Most other insurers will likely follow.
- She asked how the product “recruits my stem cells”. The clinic staff stated, “NO, we’re not recruiting your stem cells, the product has the stem cells.”.
Why is Medicare no longer covering this? It could be that IOF and a long list of concerned physician key opinion leaders in regenerative wrote a letter to Medicare and the RAC contractors discussing the details of this billing fraud. Emails also went out to thousands of physicians who were part of several organizations warning about this Medicare Q-code billing scam. So while it looks like the days are numbered for the amnio companies billing Medicare, that also means that this and many other clinics are now on the radar of the RAC companies hired by Medicare. What’s the significance of that? These companies who are paid a percentage of the recovery for Medicare will initiate clawbacks of hundreds of millions in overpayments.
So if I were the Patels or Hinsdale Foot and Ankle, or any other clinics billing this stuff, I would initiate voluntary refunds of the money paid by all federal and insurance programs now, before the feds come knocking. Why? Nobody looks good in orange.
The upshot? IMHO, stem cell recruitment therapy is yet another scam. A way to get around the simple fact that these products don’t have live and functional stem cells, but still keep the term “stem cell” in the marketing. More importantly, the claims being made are still not permitted by the FDA, so it’s more likely than not that the FDA in a Biden administration will begin going after those using this trademarked term. In the meantime, it’s great to see IOF’s advocacy for honest players in this space is beginning to have an effect. So congrats to the leadership of IOF for taking a stand on this issue!