Amniotic Stem Cell Update: This Is so Wrong…

By Chris Centeno, MD /

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chiropractor stem cell

Last month a patient walked into our office with low-back pain and a bad shoulder, ankle, and knee. He promptly told us that he had paid $14,000 for amniotic “stem cell” injections, at a chiropractic office in downtown Denver, in the shoulder, ankle, and knee. Huh? Let’s explore this a bit…

Chiropractic Amniotic “Stem Cell” Injections

The biggest medical scam to hit the nation since peach-pit extracts used to treat cancer is what I call the “Chiro Amnio Scam.” Unsuspecting patients are lured to a seminar by front-page, blitzkrieg advertising in local papers. There they find a high-pressure sales event run by chiropractors where they’re told that despite their severe “bone on bone” arthritis, magic injections of millions of amniotic “stem cells” will regrow their joints like new! They are offered discounts and package pricing if they “sign up today,” a bit like a used-car sales event. They are erroneously told that their own stem cells don’t work anymore and even if they did, there are not enough of them. There is no candidacy evaluation other than if their credit card clears.

Once they bite, they get injected with amniotic “stem cells” by a physician’s assistant or nurse practitioner, who is usually the only person in the chiro office with any amount of medical training. There is no operating or procedure room, no crash cart, no imaging guidance, just a blind injection into a joint in a chiro office that 10 minutes before was used to crack someone’s sweaty back.

The unsuspecting prey (I mean “patient”), of course, is never told that there are no viable and functional stem cells in this injection, that there is no published data showing that this injection will do anything, or that if this vial of mostly baby urine and growth factors injected into their knee actually had any living cells, it would be an illegal and misbranded prescription drug without any FDA approval. Some patients get some temporary relief, likely the same improvement that they could have gotten from a PRP shot costing 1/5 to 1/10 as much. Some, like our patient this morning, get no relief and then start trying to find out why and find our clinic.

Let’s Compare and Contrast

Do you remember “compare and contrast” from high school? This was when you had to write an essay between things that were different but had a few similarities. That’s what I’ll do today.

We made some phone calls, and here’s what we found out:

  1. The amniotic “stem cell” product they use is called “Palingen Flow.”  The problem is that it’s not FDA approved as a stem cell product, but instead is registered in a quickie 361 online process and is regulated to be a nonviable amniotic membrane and fluid product (read “dead”). The website for the product doesn’t mention that it contains any living stem cells, which is good, because if it did it would be an illegally marketed and unapproved drug. This is consistent with the lab research performed by the Interventional Orthopedics Foundation. 
  2. A nurse practitioner performs the injections, not a physician specialist.
  3. There is no procedure suite; this is a chiropractic office.
  4. The nurse practitioner does use ultrasound.
  5. Their success rate is an astounding 97%!

Cost

The first place to start is perhaps the most obvious. The cost for a multijoint PRP injection (3 joints) was $14,000. That means he got a $1,000 discount for multiple joints. The cost for a bone marrow concentrate procedure here, which does actually contain live stem cells, would have been several thousand dollars less.

Practitioner

For paying top dollar, this patient had the procedure performed by a nurse? Yep, there is no MD or DO physician in the office. For a procedure costing several thousand dollars less, he could have had a real physician who has been through residency training and fellowship to perform these procedures. The difference in years of training? A nurse practitioner typically has six years after high school. A fellowship-trained physician has 13 years of training, which is why a nurse practitioner is called a “midlevel” (i.e., not a real physician). In addition, the Interventional Orthopedic Foundation wouldn’t even consider the nurse as eligible to take their courses; there simply isn’t enough background training.

What’s Injected?

As discussed above, the FDA regulates Palingen Flow to be a dead-tissue product. The chiros in downtown Denver are claiming that this is a “stem cell therapy.” It is not. Our high-dose bone marrow concentrate actually contains live stem cells, a fact we’ve proven to ourselves more than 1,000 times by culture expanding these living cells here in Colorado and later through our licensed facility in Grand Cayman.

Facility

Our procedures here in Colorado would be performed in dedicated procedure suites with everything you see here (which costs in total several hundred thousand dollars):

This is what the average chiropractic office room looks like:

Image result for chiropractic office room

An adjusting table and two chairs. Yep, your procedure will be performed on the same table some guy just sweated all over while getting his adjustment. What if something goes wrong? The nearest help with any equipment will be a 911 call away, so you better hope they get there quick.

Research and Success Rate

Is there any research published on using Palingen Flow for any of the conditions that this gentleman presented with? No, absolutely none. Is there any research and published data for our HD-BMC in these conditions? Yes, quite a bit that we have published and that we make available online every month.

The downtown Denver chiropractic office quotes a magical success rate of 97%. Is that published somewhere? Did they collect that data? This reminds me of when I shadowed a chiropractor for a day in residency. I’ll never forget that he asked every patient after an adjustment, “So tell me how much better you feel?” For a medical doctor trained in a large university setting, this was biasing the patient to report positive over negative results. So if you believe that the real success rate of these injections is anywhere near 97%, I have some flying pigs I’m selling at $1,000 off!

Why Would Someone Pay $14,000 to Be Injected with Dead Amniotic Tissue by a Nurse?

The problem is that these patients aren’t told the truth about what they’re getting. They’re getting charged as if they’re paying for a Rolls-Royce, but they’re really getting a beat-up 10-speed bike. This is a big issue as it represents consumer fraud on a massive scale. Unlike other chiropractic bait-and-switch programs, like paying ten thousand dollars for super-traction, this one also intersects into the world of unapproved FDA-regulated cell drugs. Meaning that the consequences for this type of fraud come with real federally enforced teeth.

The upshot? This is so wrong on so many levels. The nurse working for this clinic has an ethical obligation to understand that he or she is not actually injecting stem cells. The chiropractors have an ethical obligation as well. In the meantime, this poor guy is out 14K for having a nurse inject his joints with dead tissue in a chiro office!

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10 thoughts on “Amniotic Stem Cell Update: This Is so Wrong…

  1. Karen

    Thank you for that!
    I cannot believe the number of credible Orthopedic surgeons offering amniotic stem cell treatments. How can they do this and why ? Are there any viable amniotic stem cell treatments out there ?
    Thank you and see you soon for a real stem cell treatment

    1. Regenexx Team Post author

      Karen,
      We’ve tested every amniotic, umbilical, placental and cord blood product we’ve had access to, and have found no live and viable stem cells in any of them. Are the Orthopedic surgeons using these products as “stem cell” treatments? Look forward to seeing you!

  2. DaveNG

    Modern day snake oil salesmen. How is this even allowed? Seems like this is at least a class action suit just waiting to be filed.

  3. Lorraine McCarthy

    THAT’S WHY i AM GOING STRAIGHT TO THE SOURCE: REGENEXX.

  4. Mike Cullen

    I had a stem cell procedure done at dr cohens clinic in Carlsbad Calif. in March of 2017 it took a full week to do my knee that was bone on bone… it’s been over six months and it just gets better and better, I’m walking two miles a day and it’s pain free, except for going down hill.. so far I’m pleased with my results,,,I would like to get it x rayed to see if it’s really growing..

  5. Lorraine McCarthy

    What is “moderation”?

  6. Chip

    What was the name of the chiro clinic in downtown Denver?
    What is the cost of regenexx?
    Thanks
    Chip

    1. Regenexx Team Post author

      Chip,
      We made a decision not to include the name of the Clinic as any Clinic injecting injecting an amniotic “stem cell” product as a stem cell treatment, performed by a nurse practitioner in a Chiropractic office room rather than a dedicated fully equipped procedure suite would be similar. The cost of Regenexx treatment depends on what’s needed in each individual case, but as stated in the blog, the cost for a bone marrow concentrate procedure here, which does actually contain live stem cells, would have been several thousand dollars less and PRP a fraction of the cost.

      1. Glenn Whitted, MD

        Good for you performing procedures, as an orthopaedic surgeon, which require the availability of a crash cart. Most of your colleagues would say that what you are doing does not require such elaborate preparations – nor a crash cart – even with patient safety uppermost in mind. Probably every American hematologist who ever harvested a bone marrow transplant would look askance.
        For more information on whether ACTUAL stem cells (live or dead), are even required for the effects you wish to achieve with Regenexx therapy, regardless of their origin from bone marrow, fat or placenta, read the work of Thomas Tulenko, PhD, a 40-year stem cell researcher from Thomas Jefferson University, who might debate that it is probably not the cells that are important in “stem cell” treatments at all. Likely EVERYTHING ELSE but the cells are the key elements in the success of these treatments – Regenexx also. Generally basic science supports clinical trials; it’s not our clinical experience that validates the underlying science.

        1. Chris Centeno Post author

          Glenn, any injection that involves anesthetics (or anything that could get into a major artery and cause it to clot) requires basic resuscitation equipment close by. We also perform quite a few spine procedures. However, performing these procedures in an office, with a nurse, blind without guidance and with no resuscitation equipment (which is often the case in chiro offices) is far below the standard of care in 2017. On whether being a surgeon is an advantage or disadvantage in this new field, please watch my recent lecture to get a sense of how I view that: https://www.youtube.com/watch?v=8K8UA7-OR6Q
          On Tulenko, he sent IOF this letter about 18 months ago: https://regenexx.com/wp-content/uploads/2017/10/IOF-response-01-2015.docx I would encourage you to read our response: https://regenexx.com/wp-content/uploads/2017/10/Letter-Response-to-Thomas-Tulenko-PhD_2-2016-1.pdf The point being that these products may have GF’s that help healing, but these GF levels are far lower than much cheaper PRP. In addition, the issue is not that they may have some therapeutic benefit, but that advertising these procedures as a “stem cell therapy” is consumer fraud.

Chris Centeno, MD

Regenexx Founder

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.
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