Publishing research is hard. That's why in the field of regenerative medicine so few have done it. In fact, as you look around out there at places that might treat your knee osteoarthritis, no matter how credible the outfit looks, none have published serious research. Meaning, you have no idea whether what they do and how they do it actually works. That's never been the case at Regenexx, and this week we just added a high-level research paper on knee arthritis to our portfolio.
The Stem Cell Wild West
This week one of our young doctors at Colorado HQ came to me and showed me the website for a local orthopedic clinic that hired a company to make a lab. While this offering was credible, in that I know the company that did the lab and they're doing real stuff, there were huge differences. First, as I looked at our thousand-foot c-GMP class clean room and multimillion-dollar research facility and compared that to the hood in a room at the local clinic, that was one set of stark differences. But the real difference was the fact that we have been collecting data on what we do and how we do it for more than a decade. This local orthopedic website said that this clinic hoped to collect data. So let's explore that hope versus reality.
The Hope vs. Reality
The local orthopedic clinic described had an aspiration to collect data. However, no clinical data has been collected or published. In fact, I know the principles of this company, and the doctor involved has been doing this work since 2008 when he came to see what we were doing. So that hope of collecting data and publishing it has been there for a decade without a single publication ever being created. That's extremely common in our field. I have met hundreds through the years that hope to collect and publish data, but, somehow, that never happens. Why?
The reality is that collecting data is hard. It takes a reengineering of the way the clinic works. It requires staff to make sure it's getting done. It takes an expensive registry system to track it all. Biostatisticians are needed to slice, dice, and test the data. Then you need expensive physicians who want to take the time to write the research paper. Finally, you often have to go through an exhausting back-and-forth with journal reviewers before you get the green light for publication. In all, it's hundreds to thousands of hours of time per paper to publish data.
Our Prior Publications
Unlike the company that built the orthopedic cell processing lab or really almost everyone else doing anything in orthobiologics (including many universities offering these therapies), we have been publishing in this field since 2008, which meant that we began collecting data in 2005. In fact, our first 2008 publications of cases where we observed MRI evidence of cartilage and meniscus regeneration with culture-expanded mesenchymal stem cells were the first papers of their kind on planet earth. Since then we've gone on to publish large data sets on knee, hip, and shoulder arthritis. We've also published smaller case series in hand arthritis and bone healing. We've published knee arthritis dosing studies and comparison trials as well as two MRI case series of knee ACL injuries. Finally, we've written basic science papers based on lab research data, with a new one of those (in high-dose platelet-rich-plasma-based tendon healing) being accepted and due out in January. In fact, as of last August, if you look at the number of patient results published in the world literature in bone marrow stem cells, we have published 44% of it worldwide. So there's no larger single contributor to the research in this field other than perhaps Philippe Hernigou in Paris. To see our all of our stem cell research publications, click here.
One of the reasons why publishing data on specifically what a clinic offers is critical is that there are stark differences in the way platelets and bone marrow can be processed and used. For example, we use a very specific type of ultrahigh-dose PRP and bone marrow. In addition, there is no machine or lab process out there that can mimic what we do in our flexible lab platform as these procedures are protected by several US and international patents. So let's break this down:
Who does the procedure is critical. For example, the local orthopedic clinic and many chiropractic clinics have a physician assistant or a nurse practitioner do these procedures. These providers, in our clinic, aren't even qualified to be trained.
What is injected is very important. In our case, as discussed, what we inject is very different from what this orthopedic clinic injects. It's also very different from what can be made in a bedside centrifuge.
How you inject is also paramount. Meaning, most clinics will just blindly stick a needle in the general vicinity of the problem area without using guidance to confirm that the cells got to the right place. In addition, while some clinics use ultrasound, you really need both ultrasound and fluoroscopy (real-time X-ray) to do these injections accurately in all circumstances.
Where the cells go is also crucial. Meaning, using guidance to get them to the right spot is key, but observing where they go once injected is needed. For example, you can use ultrasound imaging to place a needle in the base of the ACL ligament. The problem is that without using fluoroscopy and radiographic contrast, you can't observe that the cells are getting to all of the various parts of the ligament that are damaged.
When the cells are injected is also significant. For example, the Regenexx arthritis protocol is a patented series of injections. The first procedure sets the stage for the action of the cells by causing local inflammation. Then, several days later, the cells are injected. Finally, a third injection adds medications and additional platelet growth factors to "fertilize" the cells. Almost all clinics out there just shoot the bone marrow cells into the knee on one day and call it good.
So as you read this paper, realize that the Who+What+How+Where+When is VERY different from what your local orthopedic surgeon or chiropractor offers.
Our Newest Paper
Our newest research is on using our patented Regenexx injection technique on patients with moderate to severe knee arthritis. These patients were randomized to either a treatment group or physical therapy. The patients who were assigned to the therapy group were given the option to cross over to the Regenexx group at three months if they had had less-than-satisfactory results from PT alone.
The results showed that the Regenexx therapy was better than physical therapy. In addition, patients showed significant improvements along multiple pain and orthopedic functional metrics. In essence, this is now high-level data showing that our specific protocol works. It is not evidence that all bone marrow therapies work. In fact, as I have intimated above, you would need to test that specific protocol to see if it worked. In addition, our protocol is VERY DIFFERENT from those used by other clinics.
The upshot? We're proud to lead the way in orthopedic stem cell use with yet another research paper. In the meantime, please be careful out there, as understanding Who+What+How+Where+When is critical in making sure you don't get taken for thousands of dollars to be treated with an untested bone marrow or other stem cell treatment protocol.