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.