There have been a number of expensive devices released on the market these past few years that purport to harvest many more stem cells from bone marrow. However, these devices have not passed our independent lab tests. Given that new ones are hitting the market all the time, we thought a parody video would be in order. So in that spirit, we would like to poke fun at ourselves and the regenerative medicine industry and introduce the PlungiStem 5000.
How Stem Cells are Harvested
You would think that harvesting bone marrow from a patient would be easy. However, it actually takes some work to do it right. But before we get into that, let’s review how this process works.
What generally happens in a bone marrow aspiration (BMA) is that a specific type of needle (trocar) is used to basically perform what looks like a blood draw from the bone. Since bone is more like hard plastic than cement, a trocar will penetrate it easily, and once cannulated, the doctor draws out the liquid portion of the marrow.
First, most patients believe this procedure is painful. In fact, when the back of the hip area (PSIS, or where we draw from) is properly numbed, it’s actually not a big deal for about 90% of patients. Almost always, the patient gets off the table and says that the procedure is not nearly as uncomfortable as they had feared.
Second, most doctors who perform this procedure do it in a substandard way because it’s easier for them, but it shortchanges the patient. This happens when the doctor inserts the needle and draws what he or she needs (usually 60 cc) from that one site and calls it good. Why does this hurt the patient’s chances of a successful treatment? Because we know from multiple studies that stem cell content is important for patient outcomes, meaning more stem cells means a higher likelihood of excellent results. After the first few cc’s, the stem cell count drops off a cliff, and the doctor is mainly drawing stem cell-poor blood rather than stem cell-rich bone marrow. Hence, a high stem cell content bone marrow aspiration takes time. To do it this way, the doctor has to take small samples from many different areas, which paradoxically dramatically increases stem cell yield. To learn more, see my video below:
The Magic Stem Cell Harvest Devices
There is likely nobody else on earth, other than Philippe Hernigou in Paris, who has more experience drawing bone marrow for orthopedic stem cell procedures than myself and my partner, John Schultz. We would be tickled pink if a device showed up that could save time and get dramatically more stem cells. Hence, as each new device has come on the market that purports to get more stem cells, we have paid attention and tested it in our lab. The problem? The data from each of those experiments has been a huge disappointment.
This all began about six to seven years ago with a device called a Marrow Miner, which looked like a Roto-Rooter cable that chewed through marrow. We tested it and we were surprised by how invasive the device was compared to the usual BMA, but we were optimistic that maybe this thing would work. It, regrettably, didn’t get any more mesenchymal stem cells than using a traditional and less invasive Jamshidi needle.
Next up was the Ranfac device called both Marrow Cellutions and the Maxx Regen. Regrettably, this device didn’t work as advertised. This was found not only in our tests but also those performed by another party. See my video below:
Finally, we have seen other device companies broadcast their desire to enter this market. It seems like they are all salivating on the margins of a piece of plastic and surgical steel made in China for $20–30 that sells for more than a thousand dollars.
Why Does Regenexx Spend the Money to Test These Devices?
Given that every other physician network would just take the data offered by the company selling the device as gospel, why does Regenexx not do that? Because for us, the device really has to work as advertised. Hence, we have spent tens of thousands of dollars in employee time, lab costs, and physician time running our own tests on each device.
Our Parody Is Born
As you know, we have a fellowship program where we educate specialist physicians in what we do and in advanced interventional orthopedics using orthobiologics. One of our fellows, Matt Lucus, DO, from Stanford, was working with me this past week, and we shared a chuckle over a picture of one of these new bone marrow devices that will soon enter the market. We obviously don’t expect this device to work any better than prior devices, but how to get this point across to doctors and patients? After all, we have already published serious lab data on the topic. Was there a better way? We both settled on a parody and began batting a prototype around in our heads during a procedure. The PlungiStem 5000 was born!
Within a day or two, we had both constructed a simple version of the faux device by cobbling together stuff we use every day. Two trocars, some tubing, a few filters, and some syringes. However, the prototype needed something else to set it apart. That’s when I came up with the idea of a plunger. I dutifully (no pun intended) sterilized a bathroom plunger with multiple types of medical bactericides, and some Coban tape was used to add it to our tubes and syringes. The name was then a simple matter of combining “plunger” with “stem cell.”
The upshot? Please watch our video above. However, most important is the medical message behind the parody. That at the end of the day, a simple Jamshidi trocar used correctly in a time-consuming procedure always beats a complex device to draw the maximum number of stem cells! Meaning, getting more stem cells is a function of using your head to plan the procedure and your wrist to place the trocar in the right spots to draw small volumes.
JUST TO MAKE SURE EVERYONE IS AWARE, THIS IS NOT A REAL DEVICE. IT WAS NOT USED IN A REAL BMA. THE PROCEDURE WAS FAKED (MEANING THE TROCARS WERE NEVER INSERTED NOR DID THE DEVICE BREAK THE SKIN). THIS IS A PARADOY FILMED TO PROVE AN IMPORTANT MEDICAL POINT.