Dose is a key issue in medicine, yet for same-day stem-cell treatments nobody seems to know the correct dose nor have a way to measure it so that it can be adjusted to help patients. A newly published Regenexx research paper begins to answer some of these critical questions.

Regenexx doctors have been using stem cells to treat orthopedic conditions since 2005, a lot longer than anyone else. They’ve identified three stages in how a physician interacts with this new technology:

• Stem-cell therapy is magic
• Stem-cell therapy helps a lot of people but is not magic, just another great tool to have
• Who does stem-cell therapy help the most and why?

If the doctor just took a weekend stem-cell course (which is the training received by 90 percent of physicians using stem cells on patients today), they’re still in the “stem-cell therapy is magic” phase. They have little personal experience of what these cells can really do in specific patients and what they can’t. These doctors’ only experience comes from the physician who taught the weekend course, which typically focuses on the instructing physician’s most successful cases.

Some doctors who have been using stem cells for a few years have graduated to the “stem-cell therapy helps a lot of people but is not magic, just another great tool to have” phase. This is when reality sets in that like any medical procedure, stem-cell therapy works for many patients, but some simply don’t respond to treatment.

Very few doctors using stem-cell therapy today have graduated to the “who does stem-cell therapy help the most and why?” phase. This is when the doctor begins looking at data to see how to turn an art into a more exact science. Regenexx doctors have been looking at biostatistical analysis of our registry data for years. In fact, it was one of those analyses that birthed this most recent paper.

Several years ago Regenexx doctors noted that patients in the stem-cell treatment registry who had both knees treated just didn’t do as well as those who only had one knee treated. At first the doctors thought that this was because they had identified a group of patients with more severe osteoarthritis, but the data didn’t support that theory. For example, while patients with three or more osteoarthritic joints at the time of their treatment did worse, patients with two joints did not. So doctors began to look at dose. Unlike almost all clinics that do this work, Regenexx doctors have been counting the total number of cells injected for many years. When the doctors ran the statistics on this information, they saw that patients who got fewer than 400 million cells per knee had less pain relief. They tracked this trend for a while before deciding to publish the findings.

What’s really amazing is that not only did Regenexx doctors find a minimum dose per knee to maximize the chances of success, but the dose counting method is clinically practical. This is very unlike the dose metric usually used in medical research, a count called colony-forming units (CFUs). This is when a lab places the stem-cell sample in culture and the number of colonies that form are counted. While it’s a neat little trick to find a rough estimate of the number of stem cells and is used widely for research, it’s completely useless for finding out the dose of cells at the bedside when that data would come in handy. In fact, it takes a week or so to find out the dose using the CFU method, long after the patient has been treated. Instead of the CFU method, Regenexx data shows that a simple total cell count of the sample may act as a proxy for dosing.

Regenexx doctors are proud to be well into the third phase of stem-cell use—the one where the art begins to become a science and the doctor can do things to choose the patients who are most likely to respond and adjust his treatment to maximize the chances of success.

“Regenexx Research” first appeared as a post on the Regenexx blog.