Regenexx in the News: Throwing the Baby Out with the Bathwater

by Chris Centeno, MD /

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You may have seen some recent news stories about the Regenexx Corporate program. One of my concerns is that these stories don’t depict our company accurately and they mark a new disturbing trend in orthobiologics. Since the media and the university talking heads don’t understand how physicians innovate, they have been unable to set a standard for responsible use of orthobiologics versus irresponsible use. Given that’s an area where Regenexx has always been a leader, let’s dig into that topic.

The Bad Actors in Regenerative Medicine

I’ve been an industry watchdog for the past 5 years or so as regenerative medicine has careened off the cliff of reality into the chasm of fantasy. When former FDA head Scott Gottlieb coined the term “Bad Actors” that was a great moment, in that I had been discussing on this blog for years that the fat stem clinics offering cures for every known disease were a big problem. Since then, things have gotten even crazier as I worked with countless reporters to understand the umbilical cord and amniotic fake stem cell treatment space.

PRP and Bone Marrow Concentrate

At Regenexx, we use two main orthobiologic staples to help patients. Platelet-rich plasma and bone marrow concentrate. The former is a mix of concentrated platelets and the later is a procedure where the stem cell fraction in bone marrow is isolated and re-injected.

If There are Bad Actors, Who are the Good Actors?

If there are bad actors, then there must be the opposite, good actors. For the use of bone marrow concentrate, one way to try to define that might be, as the press has tried to do, to say that all good actors get FDA approval for their “product” before using it in patients. The problem with this analysis is that bone marrow concentrate is often created by FDA 510K cleared machines and isn’t eligible for FDA approval because it’s minimally manipulated. In fact, it fits squarely under the agency’s own 21 CFR 1271.15(b) same surgical procedure exemption for something they don’t want to regulate. In fact, bone marrow isn’t a tissue that FDA regulates at all. In addition, since it’s autologous (from the same patient), it’s also not eligible for 361 tissue registration, another FDA pathway. In fact, bone marrow isn’t even listed on that form.

So we can’t define a good actor by one that gets FDA approval for the use of bone marrow concentrate, as the FDA doesn’t want to regulate that substance. That’s likely because this is a known orthobiologic with studies on its orthopedic use going back to the 80s. So what else can you use to define a good from a bad actor?

Defining a Good Actor

I recently blogged on the problem of academics and science journalists not understanding physician based innovation, primarily because they’re only used to reporting on new drug discoveries.  In that piece, I defined a good actor as:

  • The substance being used is not classified by FDA as a drug that requires approval but fits squarely into the physician practice of medicine
  • Based on the existing research, the innovation is more likely than not to be safe
  • All consented patients are tracked in a registry that queries patients for outcomes and complications at set time points
  • Research on the procedure is published using the pathways described above
  • Based on the data collected, strict candidacy guidelines for who is and who is not a candidate for the therapy are established

A bad actor looks like:

  • The substance is classified by FDA as a drug that requires clinical trials before use
  • There is poor existing research, so the safety of the therapy is completely unknown
  • No patient results or complications are tracked in any formal way
  • No research is published
  • Everyone is a candidate

Throwing the Baby Out with the Bathwater

Regenexx has published 23 studies on the use of orthobiologics. That’s more than any other single author in the space other than maybe Phillipe Hernigou. We have published one randomized controlled trial and have three more in the works, with two nearing completion. We use bone marrow concentrate, have published the world’s largest orthopedic stem cell safety study, track all patients in a registry, and have strict candidacy guidelines. Of all the physicians out there using orthobiologics, none outside of our network can really make this claim. Some may have begun using a registry, but most don’t. Few have published anything on the procedures or techniques they use. More use candidacy guidelines, but few have any data on which those guidelines are based.

So here’s the rub, if Regenexx isn’t a good actor, then who is? That’s a problem, as it means then that anyone using bone marrow concentrate is a bad actor, as they both can’t get FDA approval on something the agency doesn’t want to regulate and they don’t have all of the safeguards in place that Regenexx has used for more than a decade. That means anyone who is responsibly using bone marrow to treat orthopedic problems is a potential target.

The upshot? There are good and bad actors and Regenexx is a leader in all the things that make a good actor. So while the press is throwing the baby out with the bathwater, we’ll be setting the standard for what a good actor looks like. We’ll also keep pushing for all practices out there to follow the standards we and others have set.

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8 thoughts on “Regenexx in the News: Throwing the Baby Out with the Bathwater

  1. Kathryn Walker

    I read with longing your posts. I would love to have a stem cell procedure but am 84 years old, have advanced arthritis of the cervical and lumbar spines, and have very limited income. I understand reputable stem cell physicians charge several thousands of dollars and that insurance does not cover such. So, the relief provided by stem cell procedures are limited to those whose incomes will cover the costs and the remainder of us can only wish. None-the-less I wish for you and your patients increased knowledge and success.

    1. Regenexx Team

      Hi Kathryn,
      Thank you. We continue to work hard towards making these procedures available to everyone. Interestingly, we usually use Platelet procedures rather than stem cells to treat Spinal Stenosis. When dealing with Cervical Stenosis head position is very important especially when sleeping, so a pillow that helps keep your neck in a comfortable position as well as a good cervical collar can often help.

  2. Bob Dahl

    I just jogged for thirty minutes and rode my bike for several miles. I do this routine several times a week. I had the stem cell procedure on both knees at the Toledo clinic. I have approximately 40,000 miles running from age 25 to 70 and countless miles riding my bike. For the last four years, I have just jogged without logging miles. Unfortunately, I inherited arthritis in my knees. My older sister has two knee replacements. I said, “No thanks,” and found Regenexx. Thank you, Regenexx, for giving me and my knees new life.

    1. Regenexx Team

      Great to hear! So thankful for the opportunity to help, Bob!

  3. Ron Halvorson

    My journey with Regenexx began around 2011when my wife was dealing with knee replacement options, and decided on surgery. I continued my interest in the cutting edge work Regenexx was doing. My own process with Regenexx began in 2015 with bilateral knees; both of which had been treated with arthroscopic for meniscal tears of the knee. Additional treatment focused on severe degenerative disc disease lower lumber spine. My wife was convinced of my results and subsequently had treatment on her neck. Needless to say, my 79 year old body has give me many years of athletic service and I am now endeavoring to reciprocate in its care with the best medical treatment available. Thank God for Regenexx.

    1. Regenexx Team

      Thanks, Ron! So thankful for the opportunity to help…

  4. George Justice

    In September 2014 at age 74 I was scheduled to have a partial knee replacement. I opted to have stem cells and PRP at the Des Moines clinic. I have averaged over 4,000 miles a year on my road bike (5,300 last year) and we try to average close to 20 mph for 20+ miles. I average over 300,000 vertical feet skiing mostly black runs. Thanks Regenexx.

    1. Regenexx Team

      Hi George,
      Great to hear! You’ve set the bar really high for the rest of us!

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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