Why Do We Continue to Do Knee Stem Cell Therapy Research?
There are now many clinics offering knee stem cell therapy. When we were the first in the United States offering stem cell treatments for knee arthritis, we wondered if anyone else would also discover what this unique therapy can do for patients. While there are now more clinics, few have invested the resources to capture and publish data. Why? It’s easier not to do this and the data might not show what’s best for business. We are one of the few offering knee stem cell therapy who do collect and publish our data. This past week was exciting for us, as since our database is maturing to the point that important questions can be answered, we were able to answer a key one-“Is there a proper dose of the patient’s own cells that each knee should receive to maximize outcome”? The answer seems to be yes.
A dose-response study is a mainstay of modern medicine. This makes sense, as you need to know how much of something to give a patient. However, while for chemical drugs this is easy, for the patient’s own stem cells it’s very difficult. For example, in trying to figure out the right dose of a simple chemical drug, I know that the potency of the drug being given to the patient is always the same. However, for autologous cells (the patient’s own tissue), patient A may have more potent cells than patient B. Hence, a traditional dose escalation study of 10 patients getting dose A and 10 getting dose B is unlikely to be very helpful. In fact, to understand the proper dosing of autologous cells, you need massive numbers of patients who have been treated for years, so that any patient to patient differences are averaged out. This is what we were able to do this week.
We looked at many different doses versus many different metrics. We looked at various statistical models. Ultimately, when we were convinced that what we were seeing was a real effect and not just a quirk of the math, we had our number-400 million cells. Above is one of the functional scales for patients who had a > or < 400 million cell Regenexx-SD procedure performed. As you can see, there’s a big difference in the numbers, with bigger numbers on this questionnaire corresponding to better function. This difference is statistically significant, but as important, it’s also clinically meaningful.
It’s also important to note that no other provider offering same day stem cell treatments in this country has any idea based on extensive clinical data what the proper dose of cells should be. It’s all a “guesstimate” based on what seems to work. While there’s nothing wrong with that for a new therapy where dose can be tough to establish, data should be collected to better justify dosing as time goes on. Nobody else is doing that right now other than Regenexx. In fact, the vast majority of clinics aren’t even counting the number of cells that are being placed back into patients. In addition, note that this 400 million number per knee only applies to the proprietary Regenexx-SD procedure. This is because of the way we isolate cells and what we isolate is quite different than other procedures being offered.
The Regenexx Difference
The upshot? Why do we continue to do knee stem cell therapy research? The first reason is to continue to improve procedure results and outcomes for our patients. The other main reason, however, for spending the resources on doing this research and publishing it in peer reviewed journals is so that by sharing this information with our colleagues, stem cell therapy will become the common practice of medicine and finally therefore begin to be covered by insurance.