This past year there was an increase in physicians using what I call a “quickie” bone marrow stem cell procedure. This basically skips the bone marrow concentration step in favor of using a fancy device to draw the marrow. It’s certainly easier for the physician, but is it shortchanging the patient?
A bone marrow concentrate (same-day stem cell) procedure consists of three main steps. First, using a standard trocar instrument, the doctor harvests bone marrow aspirate (BMA). Second, the BMA is centrifuged. This means that the whole bone marrow is spun to concentrate the stem cells. The result is a bone marrow concentrate (BMC), a stem-cell-rich cocktail. Finally, the BMC is reinjected into the patient.
There is a new trend some physicians are following that short-cuts the BMC procedure by eliminating the second step altogether. It involves using a fancy new device (called “Marrow Cellutions”) to extract the bone marrow aspirate, and then the BMA is directly reinjected. In other words, the BMA is not centrifuged to concentrate the stem cells. The company that makes the device claims that it can obtain the same or greater number of stem cells without concentrating bone marrow in a centrifuge.
If it were this easy, it would certainly expedite the procedure, so like with all products we consider, we tested the Marrow Cellution in our advanced research lab against the standard BMC procedure. Regrettably, the results of our testing weren’t promising for the quickie bone marrow stem cell procedure as the Marrow Cellution device failed to produce as many stem cells as the standard BMC procedure. In fact, it wasn’t even close. BMC had many many more stem cells. Additionally, it was no better at harvesting BMA than the traditional trocar used in the same way. Others who have also tested the device have confirmed similar research findings.
If this is the case, why would a physician take this shortcut? The company has produced some white papers that seem to show that the device obtains more stem cells than BMC. However, these are all apples to oranges comparisons. In addition, the device skips a step, so it’s easier for the physician. However, none of this makes common sense.
Concentrating the bone marrow (i.e., the BMC procedure) certainly takes more of the physician’s time than just harvesting and reinjecting (i.e., the quickie procedure) the bone marrow aspirate, but (based on our data) it results in greater numbers of stem cells. However, does the number of stem cells reinjected really matter?
The early research on bone marrow stem cell treatment demonstrates that you need a minimum number of stem or other cells to get the best outcome. In fact, if you watch the video above, you will see one of our research papers showing that we need a minimum of 400 million total nucleated cells to get a good outcome for knee arthritis for example. There are other research papers on healing fracture nonunion and low-back disc tears that tie a better outcome to more stem cells in the mix injected.
And there’s another big problem for the Marrow Cellution device. Because almost all of the world’s research on how stem cells can help orthopedic problems has used BMC, also known as a same-day stem cell injection procedure—not the bone marrow stem cell procedure using the Marrow Cellution device—we really have no clue whether or not the device works. With all the research available, we do, however, know that the BMC procedure works for many orthopedic conditions.
Another problem for the Marrow Cellutions crowd is that we don’t even have any animal data showing that this approach works. While some physicians can hang their hat on the idea that the stem cell procedure they use doesn’t have any clinical data, there is ample animal research showing their approach works. This isn’t the case for Marrow Cellutions, as not only has the company that manufactures the device not invested in clinical trials, it has also not invested in any animal studies to show this approach will do things like heal cartilage, bones, tendon, and so on.
This dichotomy presents an ethical conundrum for physicians using this device, as they must rely on BMC research to claim that the device is effective, as who wants to pay thousands of dollars to get a procedure that has no data that shows it works? However, if they rely on BMC research, they violate a basic ethical medical principle by participating in a bait-and-switch fraud. Basically, BMC seems to work based on the research, so I’ll claim that Marrow Cellutions works the same way.
Understand, first, that if you get a quickie stem cell procedure, which results in fewer stem cells reinjected than a standard BMC procedure, you may be reducing your odds of a positive outcome.
So how would you know if you’re getting a quickie stem cell procedure versus a BMC procedure? Listen closely as your physician explains the procedure. If he or she is taking out bone marrow and reinjecting it within a few minutes, within the same procedure, this is a quickie procedure. Ask the physician if he or she isolates or concentrates the stem cells before reinjecting. If the answer is no or that concentrating stem cells isn’t necessary as the instrument they use draws enough stem cells (they may even claim the device concentrates marrow stem cells for them), this is likely a quickie procedure.
At this juncture, based on our testing and the testing of others, I cannot recommend a quickie bone marrow stem cell procedure over a standard same-day BMC procedure. While this shortcut may save you and your physician some time, based on what we know at this point, the outcomes are less likely to be as favorable with the quickie stem cell procedure. This may make less a difference in young patients and more difference in older patients.
In all fairness, it’s important to note that the quickie marrow procedure may work in other ways. For example, it may produce enough important cytokines that can help a joint. However, since none of this has been studied at this point, we can also postulate the opposite.
The upshot? At this point, I would avoid a quickie bone marrow procedure. We don’t have any animal or clinical data that this type of procedure is effective. We also don’t know who it will work for and who will fail this type of approach. Hence, with no data, there is little justification for charging patients for the procedure.
About the Author
Christopher J. Centeno, M.D. is an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. He is board certified in physical medicine as well as rehabilitation and in pain management through The American Board of Physical Medicine and Rehabilitation.…