What Is the Stem Cell Machine?

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stem cell machine

One of the more interesting aspects of the increasingly dangerous stem cell wild west is the provider and patient exploitation that is occurring because of misinformation. Today I’d like to highlight what should just be legally sold as a shockwave device, but instead, a chiropractor in Atlanta is selling it as “The Stem Cell Machine”. Let’s dig in.

What Is “The Stem Cell Machine”?

stem cell machine

So what is this? Turns out this is a simple ESWT machine using decades-old technology and being resold by a chiropractor by the name of Matt DiDuro.

What Is ESWT?

ESWT stands for Extracorporeal Shock Wave Therapy. This technology is a half-century-old as it was first used in 1971 (when I was in third grade) to treat kidney stones. It works by creating a high-intensity shockwave that injures the tissue. For orthopedic problems, this technology works much in the same way that prolotherapy injections create a microinjury to prompt healing.

We’ve never used it because it’s like using a sledgehammer to put in a finish nail. Meaning, there is no way to direct this energy to specific spots, the best you can do is to create a microinjury to a region. So the sharpshooter technique we usually use to inject orthobiologics into the specific areas of injury is replaced with a shotgun approach.

Does ESWT Work?

For the most part, there is good data that ESWT works to help tendon and fascial injuries that are easily accessible. Meaning, for something like plantar fasciitis, where the plantar fascia is superficial and can easily be accessed with sound waves, ESWT takes about 6 treatments to get an effect. That compares to the efficacy of a single ultrasound-guided PRP injection to get the same effect.

However, for something like an ACL tear where the ligament is buried deep inside the bone of the knee, ESWT is not going to be as effective. Why? It’s difficult to bounce sound waves into the knee when there is bone is the way. The same would hold true with most spinal problems.

Is a Half Century Old Technology a “Stem Cell Machine”?

All orthopedic tissue healing involves local progenitor cells or mesenchymal stem cells. So if you go out and sprain your ankle, it’s the local stem cells that help heal those damaged ligaments. If a doctor injects prolotherapy solution to cause a micro-injury in those nonhealing ligaments, it’s stem cells that help heal that injury. If you apply an infrared heating machine at home to improve blood flow and cellular activity in those sprained ligaments, again, it’s stem cells that heal that injury.

So while ESWT healing also involves stem cells, calling this a “Stem Cell Machine” is a HUGE stretch. That would be like saying that the infrared unit we sell in the office is a “Stem Cell Machine”. Or that deep tissue massage or Rolfing, since these both cause some local tissue damage, are stem cell therapies.

Reaching out to Dr. DiDuro

In my quest to find out more about this device, I booked an appointment to speak to a sales rep. I got both the rep and the chiropractor who is selling the device, Matt DiDuro, DC of Atlanta. I asked some hard-hitting questions and here’s what I learned:

1. Matt told me that since there are animal studies that show that ESWT activates stem cells, then he feels that he should be able to call this a stem cell machine.

2. When I brought up that this name changes the regulatory classification of this device from a simple 510K clearance to a PMA, he was confused by these terms.

3. He told me about all sorts of clearances by the FDA for all sorts of indications including “tissue regeneration” and then told me that he would send me the FDA documentation. All I got was a simple 510K clearance for the use of the machine to help diabetic foot ulcers (see below):

orthogold shockwave device

In fact, the only reference to “tissue regeneration” in the entire document is the reference to “Tissue Regeneration Technologies” which is a company where Dr. DiDuro sits on an advisory board and that submitted the 510K.

Does the FDA Know that this Device Is Being Marketed as “The Stem Cell Machine”?

NO. There is no mention of uses like tissue regeneration or stem cells in the FDA 510K clearance, which is focused on a device to treat diabetic foot ulcers. To understand why that’s critical here, you need to learn a little something about how FDA device approvals work.

The easy way to get a device to market is a 510K clearance. This process is quick and relatively cheap. Meaning an experienced company can get one in about 6 months with a small business filing fee of $3,108. All in, the cost is usually on the order of tens of thousands to get everything together to submit the application.

A 510K clearance is all about pointing to a predicate device that is similar to yours and was usually grandfathered in or has received FDA approval. Hence, the only thing you need to prove to the FDA is that your device is “substantially similar” to the device they accept. Meaning the FDA is not really looking at any clinical data on how your device does or doesn’t work. This is why this is such a fast and cheap process. The downside? This process dramatically limits what you can say about the device’s efficacy.

On the other side of the FDA approval coin is a PMA, which stands for Premarket Approval. Hence if Dr. DiDuro wanted to claim that this device works by activating stem cells, like this statement on his website:

“Immediately following treatment there is typically a significant reduction in pain, swelling and inflammation, as well as improved range of motion. Four to eight weeks after treatment there is an increase in blood vessels and circulation, which supports faster healing of tendon and bone. And for up to twelve weeks following a treatment there is a recruitment of stem cells to the treated area for the regeneration and healing of tissues.”

He would need to file for a PMA. That requires a filing fee of almost 100K for a small business and requires clinical trials to prove the statement. It would take at least 2-3 years to perform the studies needed to prove this statement plus likely tens of millions of dollars.

More Exaggeration?

the stem cell machine

So have these academic medical centers like Harvard or Mayo Clinic approved the use of their logos or do they endorse “The Stem Cell Machine”? Nope, not according to DiDuro. These are simply places that own machines.

Misbranding?

Misbranding simply means that a manufacturer is claiming something that he or she is not permitted by the FDA to claim. IMHO, all that Dr. DiDuro is permitted to claim is that this ESWT device can be used to treat diabetic foot ulcers. Stop, do not proceed any further. So calling this a “Stem Cell Machine” with the description above, IMHO would be misbranding. In fact, merely pointing to the FDA 510K clearance above (which is done twice), may cause problems for Matt based on this statement brought up in the 510K registration letter provided to me:

Sec. 807.39 Misbranding by reference to establishment registration or to registration number.
Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.

Misbranding is some serious stuff and this is what the law says about that:

“Section 331 involving a mislabeled consumer product other than certain drugs is punishable as a misdemeanor, carrying a maximum sentence of one year in federal prison and/or a $1,000 fine (21 U.S.C. § 333(a)).”

The upshot? Is this really a “Stem Cell Machine? Not IMHO. In addition, while it was represented to me that the FDA cleared the device for “tissue regeneration”, no such documentation exists based on what I was sent. In addition, describing this device that way may carry serious consequences. As I always say, you can’t make this stuff up!

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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5 thoughts on “What Is the Stem Cell Machine?

  1. Carolyn DeSilva

    You have discovered quite a number of quacks. They can do irreparable harm to their victims, physically, mentally, economically. Your posts about them are great for those of us who read them. But I’m wondering if you take the greater step of reporting them to the appropriate agency. I hope you do.

    1. Chris Centeno, MD Post author

      Carolyn, when I find egregious stuff I usually do, but the problem is that I’m also a working physician and Chief Medical officer for Regenexx, so there is little free time.

  2. Wayne

    So sad that a Chiropractor does that and ends up
    Negatively impacting people’s views of Chiropractic. Really just a money grab from someone who does not really have a true life calling to help people.

  3. Matthew DiDuro

    Unfortunately, Chris, you’ve made a terrible assumption. You’re lumping all shock wave devices into one basket, when no shock wave is created equally. I will explain the differences plus document your inaccurate & potential libelous statements. Especially, since I have a complete recording of our conversation. I also never said I said that it could be called the “the stem cell machine”. You FAILED TO REPORT that I specifically told you that it was nicknamed “the stem cell machine” by the nationally syndicated show “the Doctors”. This particular episode aired on November 21st, 2019. It’s clear as day on my recording how I describe it. What gives you the right to make inaccurate statements, falsifying our conversation, when I hold the actual recording. See Georgia & Colorado are both 1 party states, which allows one person in the conversation to record it.
    (Check our Colorado law 18-9-304). Since we had 2 out of 3 agree & it’s in the terms of your opt in agreement. Your call was recorded. You made slanderous & several inaccurate statements like, “ it works by creating a high intensity shock that injures tissue”.
    The Orthogold 100, causes NO DAMAGE TO THE BODY or tissue. You’re confusing a radial device, which uses a metal stylus to damage the tissue. The radial device you refer to, is no longer even considered by the international shock wave symposium as an ESWt device.
    I’m not sure how a 13 minute conversation, where you spoke 10 minutes on our phone call telling me about this technology & everything that I’m doing wrong. You had NO CLUE, or even wanted to learn more about this emerging field on low intensity unfocused Extracorpeal Shock wave technology. I even sent you a pilot Spinal cord injury study could be the most important overview study this year, that suggests that the orthogold 100 has Neuro protectant components, shown to help neural elongation, plus activate the Toll Like Receptor 3 pathway (TLR3 is an innate immune responder). The authors state this device may be the first POTENT SPINAL CORD INJURY THERAPY!! You decided to try & create “your own story” instead of actually reviewing the correct studies. The highest form of ignorance is when you reject something that you don’t know anything about.
    Our technology is genuine lithotripsy, which utilized heat, light & electro hydraulically generated sound waves.
    We can in fact direct the energy at a specific point, because we utilize a parabolic reflector that allows us to control the energy & penetrate 8-10 inches into human tissue. So, you’re statement, “there is NO WAY TO DIRECT THIS ENERGY TO THE RIGHT PLACE” is also incorrect. You’re goal is obviously discredit me & lump all Chiropractors as con men. You also try to lump all radial & Extracorpeal Shock wave therapies (SWT) as the same device, when they are clearly different. All sound waves are not created equal & this unique patented technology is creating earth shattering results around the world. There’s an old saying, “Ignore history and perish”. Remember Dr Semmelweis, whose perfectly reasonable hand washing suggestion were ridiculed & rejected by his contemporaries. It’s funny how medicine first mocked & ridiculed him, then they copied it & now a hundred years later Medical doctors claim & accept it as their own. Things are not always as they seem, & you’ve attempted to discredit my good name & reputation, which we’ll also deal with very shortly. It would have been smart for you to review the research & let the facts clarify themselves. I NEVER SAID or implied THAT WE COULD CALL THIS THE STEM CELL MACHINE, because there were 8 animal studies that last year were submitted to the research director & producer of the show the Doctors. They are the ones that gave it that nickname. Oh, & that episode has now been viewed over 5 million times, so it’s obviously resonating with the consumer.
    We all know that animal studies are done first to give medical research a better idea of what benefits and complications there likely see in humans. We also see these studies as a precursor for what could occur in humans. There are several reasons why the use of animals is critical for biomedical research use animals are biologically very similar to humans. In fact RATS share more than 98% of DNA with humans. Also, animals are susceptible to many of the same health problems as humans like: cancer, diabetes, heart disease, etc.
    Finally, the truth doesn’t always fall in your lap, but when you have an entire recording of the conversation, it becomes much easier to disseminate the correct information. People should not leap to a conclusion. You said it in your article, you could fix plantar faciitis with one injection to 6 radial treatments. So, you implied that you have a superior procedure that injects foreign biological products & charge thousands of dollars for a single injection. People are sick & tired of trading their physical pain for a financial pain. In the algorithm of healthcare, you don’t go for the most expensive, most invasive procedures first. You start with less invasive, less expensive therapies & exhaust all alternative options prior to jumping right to expensive stem cell options. Unfortunately, regenerative medicine has become an Industry. This specific low intensity unfocused Orthotripsy procedure is a fraction of the cost & you get multiple treatments, when compared to harvesting & injecting bone marrow derived Stem cells. This procedure punctures no skin, injects no biological fluids, & has zero down time. You for got to mention that the FDA has labeled our device as a non significant risk factor. Research may also indicate that this can help activate connective tissue, decrease pain, improve circulation & stimulates the natural healing ability. Yes, It will be disruptive to the regenerative industry. I could hear the trepidation in your voice. Patients are sick & tired of being prescribed strong prescriptions, cortisone injections, expensive stem cell procedures & joint replacement surgeries. People will have the right to choose & we’re already seeing this technology being utilized around the world at an amazing rate. Why, cause it’s both efficient & cost effective. Finally, you made another inaccurate when you said, “this is difficult to use on the knee, because the sounds waves bounce off bone. The same goes for the spine”. We literally have more documented cases of non healing fractures actually improving & healing after implementing this orthotripsy procedure. The sound waves actually reverberate off the bone, & creates a positive osteoblastic activity. I look forward to you making corrections to your inaccurate article or retracting it in its entirety. I appreciate you giving me an opportunity to somewhat respond to your lies & misdirection, but also placing this argument front & center. During our call I heard the worrisome tone in your voice. That voice in your head was loud & clear saying, “what if this guy is right ?” You can mock my vision for this technology, but you can NEVER questions my motives. I’m passionate about helping patients & getting the best clinical outcomes.

    1. Chris Centeno, MD Post author

      Matt, I have published your response here. Please take the time to visit with a regulatory attorney about now additional claims being made here which include use of this device to treat spinal cord injury, fracture healing, penetration of spinal vertebrae, that animal studies are appropriate proof due to the close DNA we share with them (I wish that one were true). Based on my knowledge of regulatory law, these are all claims that you can not make when you’re the vendor of a 510K approved device. I didn’t make that law up, but it is very real. Matt, at the date of this writing, your website called this “The Stem Cell Machine”. Just because someone called it that, once you place that on your collateral, you are making a claim that is then FDA regulated because you’re selling a medical device. PRP is the patient’s own concentrated platelets, not a foreign substance.

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