Marrow Cellution: Playing Games with Bone Marrow Data in New Jersey
POSTED ON 4/23/2017 IN Research BY Christopher Centeno
Since Regenexx has the largest dedicated orthopedic regenerative-medicine network, there isn't a week that goes by that some doctor who took a weekend stem cell course doesn't take a potshot. I ignore most of these, but every once in a while, I engage that provider in order to educate my readers. This morning's hilarious example is a physician in New Jersey who is using an expensive trocar (see above) called the Cellution and a white paper that was given to him by a sales rep to claim that what he's doing is better than anybody else, including Regenexx. Let's take a look in depth at what he's doing and why his claims are silly.
Your Doctor's Knowledge of Stem Cells Is Largely Learned by Interacting with Sales Reps
It's hard to explain to someone not involved in medicine just how much influence device manufacturers have over physician education. In the area of stem cells, since doctors get very little, if any, education on stem cells in medical school, residency, or fellowship, they only have two ways to get educated. One is to go to courses, but these take time out of the practice. Also, there are few in-depth courses to take, and much of that education is controlled by device manufacturers. The other is to interact with sales reps who are trying to sell them a product. As you might imagine, somebody trying to sell you something isn't going to give you the whole story. My example this morning of a doctor who doesn't know what he doesn't know is in that last category.
The Silly Claims—Round 1
The New Jersey doctor claims that he uses a "system" to get more stem cells. He first appears to compare his "system" to other commercially available bedside centrifuges. This table is from his website:
||CFU-f per mL
|Dr. S's System
Understanding where this data comes from and what he's talking about here is important. First, this is a copy/paste of a white paper produced by a company that makes a fancy trocar called the "Cellution." A trocar is the type of needle used by physicians to draw bone marrow. Second, a CFU is a colony-forming unit, which is a rough metric of the number of stem cells in a sample.
The Cellution trocar is a device that allows the doctor to take small samples of bone marrow as the doctor drives deeper into the bone marrow at a single site. The concept is that it will increase the number of stem cells drawn using this method. Does it work? We'll examine that issue.
To delve a bit deeper into the table above, a CFU measurement can be taken when you seed bone marrow on a plastic plate. The stem cells will attach and form colonies. So the more colonies (CFUs) you get, the more stem cells that are in the sample. The table claims that the system Dr. S uses yields a lot more stem cells than these commercial systems. To be clear, what's being compared here is the number of stem cells that Dr. S gets using only the magic trocar (above) versus the number reported by the makers of commercially available bedside centrifuges, where another doctor has used another trocar to draw bone marrow aspirate and then concentrated that substance. However, Dr. S doesn't tell you that this data is really comparing apples and oranges.
First, these numbers weren't collected by Dr. S. In fact, they come from a company white paper produced by the manufacturer of the trocar Dr. S uses. They start with a CFU number for the Cellution (what Dr. S claims is his system) and then compare that amount to those produced by bedside bone marrow concentrators. I know this white paper well, and, regrettably, it's useless data.
The problem is that the physician author of this advertising piece never compared these different systems head-to-head, but rather copied/pasted the CFU values reported by the companies making these bone-marrow-concentration devices. Why is this an issue? There are dramatic differences in the number of stem cells between subjects based on age, sex, activity, and so on. Also, the number will vary with how many sites you draw from and the volume from each location. Since none of this data is reported or, if reported, it's not controlled, in this comparison, the table is meaningless. So if company X drew a single bone marrow site at high volume in an older patient and company Y used the same method in a younger patient, we would expect these numbers to be very different. Written another way without medical jargon, the table is like reporting lap times for various race-car drivers to compare their performance. However, the times you report are from different tracks, under different conditions (dry or wet), with the drivers in different cars! Hence, the comparison is meaningless.
To do this study correctly, you would need to use one patient and draw both sides in the same way and then process that bone marrow aspirate in different machines. Or in this case, compare Dr. S's magic trocar (Cellution) on one side and then a standard trocar on the other, using them in the same way. Only then would this comparison mean something. I expect Dr. S doesn't have a clue how this data was collected, as he doesn't warn the reader. So right off the bat, buyer beware.
The Volume Problem That Dr. S Doesn't Understand
Another problem with the Cellution trocar is that it's only designed to draw 8 ml of marrow. This has changed since the device hit the market, and I suspect the change was made to buff up the numbers. Let me explain.
We've known through multiple studies since the 1990s that drawing low volumes of marrow can get you a high stem cell concentration (cells/ml). We've also known that stem cell concentration reduces as you draw more volume. When the marrow Cellution device first came on the market, it was advertised as a complement to existing stem-cell-concentration devices. Meaning that you would use this device to perform a typical 60 ml bone marrow aspiration and then further concentrate the cells. However, the high cost of the device caused physicians to complain. After all, the device cost 20 times more than a standard trocar! Then the marketing changed. All of a sudden, the recommendation was to draw less volume and skip the concentration step, basically allowing doctors to replace the cost of the bone-marrow-concentration kit by buying the Cellution.
Here's the problem with the Cellution's low-volume approach. While the concentration of cells declines as you draw more from a single site, the overall number of cells increases. So while you can get a high concentration of cells by drawing 8 ml from a number of sites deep in the marrow (what the Cellution manufacturer recommends), any doctor with a simple trocar can likely beat the overall number of cells simply by using it in the same or a similar way (drawing more sites at lower volume). If he or she then has a good machine or protocol to further concentrate those cells, it shouldn't be hard to get more cells than a Cellution-device draw.
The Silly Claims—Round 2
Dr. S then goes on to dig the hole deeper. He states the following:
"For example, Regenexx, which can cost $6000, uses pretreatment with prolotherapy injections the week of the procedure, six to ten puncture sites in your iliac crest, 60 to 150cc of bone marrow aspirate which hurts, and then manual separation with additives and centrifugation or spinning of the marrow aspirate, plus the need for PRP therapy to be performed with the procedure.
Dr. Silberman's method means less cost, less time, less pain, less risk of infection, less risk of allergic reaction, less waste, better numbers."
Let's take this one statement at a time. Regenexx uses a multisite draw. True, we do this because it dramatically increases the number of stem cells. As you see above, there is no credible data that the trocar used by Dr. S will increase stem cell numbers. I've already reviewed the published research data on how the bone-marrow-draw technique can increase or decrease stem cell yields. For that information, see the video below:
Dr. S also states that our marrow-draw method is painful. While I don't see any information on his website that describes how much pain his patients feel when he digs into their bone marrow with this doohickey, you can find that information on our website. Way back before Dr. S had likely even heard the phrase "stem cells" (in 2009), we performed a study that found that in 44 consecutive patients, about 9 in 10 thought that the bone-marrow-draw procedure we use was comfortable.
Dr. S points out that we use a proinflammatory preinjection and highly concentrated PRP. Yes, that's correct. In fact, we've published 49.5% of the world's medical literature on orthopedic stem cell use (based on the n of patients reported) using that technique. Curiously, I somehow can't find a single paper using Dr. S's stem cell technique in the US National Library of Medicine or on his website. Why? This procedure has never been studied and published. In addition, you can click here right now and be taken to live outcomes on our novel procedure by body area, but somehow Dr. S. can't say the same (i.e., there is no such information available for his magic trocar-based procedure).
Finally, it looks like Dr. S is offering some discounts on his procedure. That's great, but given that the data on stem cell concentration he copied/pasted from a manufacturer's poorly done white paper is meaningless and he has no research at all showing what he does works, buyer beware! You get what you pay for...
Regenexx and the Little Guys
Dr. S's site highlights the difference between Regenexx and a small practice. At Regenexx, we test every device independently at our expense in our lab. So we would never allow one of our doctors to advertise that they use this fancy trocar until we verified that it actually produces more cells.
For example, we've tested a more sophisticated device than the one Dr. S is using that works in a similar manner to the Cellution. Regrettably, our research showed that it didn't produce better stem cell yields. In addition, we're testing the Cellution that Dr. S is using in May. While this device has been on the market for years, why has it taken us so long to test it? The manufacturer has refused to give us samples to test! They also refused to allow us to buy any to test! We finally resorted to buying several units through a third party, because we feel the need to know if it works. Also, because we trust sales reps bearing white papers about as far as we can throw them!
Even if the Cellution produces more cells than our standard draw (which seems unlikely given our tests with a more sophisticated and similar device), we would never just inject that bone marrow aspirate into a patient, as Dr. S does. We would further concentrate the stem cells to much higher numbers before injection. Why doesn't Dr. S do that? Since he's discounting his procedure, he likely can't afford to both pay for an expensive marrow-draw device and also pay for an expensive bone-marrow-stem-cell-concentration kit. In addition, since the trocar he's using produces a very small volume that isn't compatible with the commercial concentration kits he knocks, they can't be used together. So without a lab to process cells, Dr. S is at the mercy of the limitations of the magic trocar he bought.
The upshot? I could write on about all of the problems associated with the Cellution and Dr. S's website, but suffice it to say, it's clear that Dr. S doesn't know what he doesn't know. He has copied/pasted a table from a meaningless study circulated by a manufacturer to sell a product and then tried to pass this data off as his own. He has no clinical data on what he does, instead relying on authors like myself who have actually published data on a specific, novel technique. So does his procedure that uses a magic trocar to concentrate stem cells work? Who knows? In the meantime, based on the lack of knowledge demonstrated above, buyers beware in New Jersey!
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