I’ve blogged before on a bone-marrow-draw device that claims to be able to improve the number of stem cells. I’ve been a skeptic of this doohickey, but you never know until you test it. So today we’re paying for several donors to come in and allow us to compare it to the standard trocar. Let me explain.
How Stem Cells Are Harvested
Stem cells are extracted from the bone marrow using a specialized needle (trocar) in a procedure that’s known as a bone marrow aspiration (BMA). What’s drawn out looks like thick blood, which is called bone marrow aspirate. This is where the stem cells are located. The fraction of the marrow that contains the stem cells is usually then isolated and concentrated before reinjection into the patient.
Through the years we’ve compared many different methods to increase the stem cell yield in a BMA. While a few looked promising before the test, they didn’t pan out. In addition, the ones that seemed to be working well at 10 patients would be swallowed by the statistics once we hit 40 or 50 patients. Hence, my healthy skepticism.
The Device Being Tested
The device is called the Marrow Cellutions (MC). It’s a fancy trocar that purports to get from double to 5X the yield of a standard device. In fact, the marketing states that it can draw so many stem cells that there is no need for concentration of those cells. However, that makes little sense to us, as even if the device works, why wouldn’t you want to further concentrate these cells? In fact, not concentrating seems like you would be shortchanging the patient.
This is what we have planned in three paid donors (i.e., these are not patients being treated, but we will use these samples for other in vitro experiments we have planned):
1. I will draw 8 ml with the MC device on three passes in different directions and at different cortical sites. All passes will be per the MC protocol. These will be blinded and numbered by our CRC who will keep the key (i.e., first, second, third pass and device used). We will run TNCC and CFUs (these are defined under “Key” below) on all three samples. This marrow will then be combined (24 ml) and centrifuged per our internal protocol and then another TNCC/CFU (both reported per ml).
2. On the randomized opposite (control) side, I will use a standard side ported Jamshidi drawing the same exact amount and using the same protocol as for MC. The only difference between the two devices will, therefore, be the fact that the MC has a closed tip and the trocar I will be using on the opposite side has an open tip.
TNCC=Total nucleated cell count (the total number of cells in the sample)
CFU=Colony forming unit (a rough metric of the number of mesenchymal stem cells in a sample)
We have tested lots and lots of stuff that vendors want to sell us. Everything from other marrow-draw devices to liposuction equipment to amniotic and cord stem cells. Regrettably, none of it yet has lived up to the manufacturers’ claims. Hence, we test to make sure that whatever we use in Regenexx patients actually works as claimed. While we see a few physicians taking the time to test things on their own dime (i.e., not being paid by the manufacturer), this is rare in medicine. I’d like to give a big shout out to Don Buford, MD, in Texas who is also testing this device at his own expense. He, like us, wants to know, outside of the company’s promotional materials, if this thing works.
The upshot? I’m always hopeful when I go into these tests that the big claims are true. Why? The goal is always to get more cells. While it would be far easier to accept money from manufacturers to run these tests, that wouldn’t allow us to stay unbiased. Given that our lab won’t even know which sample comes from which device or run, we should have an unbiased result today and then again next week (when the CFU counts come back). If this looks promising, we’ll perform other tests on the device, as we’ve seen differences that look promising at 3 patients evaporate at 30. Either way, I’ll post the results here.