Why Regenexx Stem Cell Processing Is Very Different

POSTED ON 11/14/2016 IN Industry News BY Christopher Centeno


I got a call this morning from an orthopedic sales rep who wanted to sell Regenexx to hospitals and surgeons. I get at least a few of these a month, as the business of medicine is used to selling drugs and widgets. In the case of orthopedic sales reps, they all see that Regenexx is the most experienced in this space with the most data and publications, so they naturally believe that we have a magic kit or machine that they can sell to doctors. They're disappointed when I tell them that we have no such widget and that only a small handful of physicians are considered qualified to begin Regenexx training. To better understand why we're very different, let's look at how we get more stem cells out of the same patient than 99% of the physicians out there and how we precisely place those cells. In other words, how we create HD-BMC and the know-how that's needed to get it to the right spot. Regenexx is very different, and the primary thing that sets us apart is how we do stem cell processing, which is way more than a magic machine to process cells. The actual process includes three key steps:

  1. The Draw is the harvest. It's how we get your stem cells.
  2. The Process is how we process the draw to maximize the number of stem cells.
  3. The Reinjection is the technique we use to make sure you get the maximum concentration of stem cells in the precise location where they need to go.

Let's break these steps down more in depth, and feel free to watch the short video at the top of this post to get a real look at these steps and what we do.

The Draw


For orthopedic conditions, the best source of stem cells is the bone marrow, so the first step is the draw of bone marrow aspirate (BMA). Part of this step, for us, involves something most stem cell clinics don't do: we draw from multiple sites to maximize stem cell yield. How does this work exactly? Most regenerative medicine doctors don't know the dose of stem cells. This is strange, as in no other area of medicine is it OK to have no idea of how much of a substance you're injecting. In fact, in most areas of medicine, not knowing the dose would be considered malpractice. Hence at Regenexx, we count the number of stem cells and have research on how many cells we need for treatments for knee arthritis. Once you understand the dose, you naturally want to concentrate cells to increase that dose, to give the patient the best chance at success. That begins with taking as many cells as feasible. For example, if you take fewer cells, you'll end up with a lower dose, regardless of how high you can concentrate cells in a lab. So how does drawing from multiple sites provide HD-BMC (high-dose bone marrow concentrate, also known as a same-day stem cell treatment) and increase stem cell yield? First, when you draw bone marrow aspirate, this is where you're taking the stem cells, the raw material, out of the patient. When the physician only draws from one site, he or she usually takes about 60 cc of bone marrow aspirate. At face value this seems like a lot; however, anything past the first 5–10 cc—so 50 cc or so—is just blood. If you harvest cells this way, you're only getting up to 10 cc of stem-cell-rich material from a single-site bone marrow aspiration procedure. The rest of the draw is blood that contains no stem cells. See the problem? In comparison, Regenexx physicians use a multiple-site draw. This technique provides the physician with bone marrow aspirate (BMA) that contains a lot of stem cells because instead of drawing 60 cc from one site that contains mostly blood, we often draw 10 cc from multiple sites that would provide mostly stem-cell-rich material found in the first part of the draw. So if we draw BMA from six locations, for example, we can have closer to 60 cc of stem-cell-rich aspirate instead of the 10 cc of stem-cell-rich aspirate and 50 cc of blood other physicians are getting in the single 60 cc draw. The video above gives you some clear visuals of this comparison. Once we have the proper draw, we can turn our focus to the next step: the processing.

The Processing


Now that we have our bone marrow aspirate, the second step is processing, or getting rid of the part of the aspirate we don't need so we can just get to the stem cells. That's what we do through our HD-BMC technique. We have to concentrate the stem cells before injecting them into the affected joint to maximize results and provide patients the best chance of success. Another reason we do this is that a joint can only hold so much injectate (the material being injected). For example, a thumb joint will only hold about 1 cc. However, when most physicians use a simple, little bedside machine to process bone marrow, they're given about 10 cc of material from the machine! That means any stem cells that were concentrated are distributed in 10 cc. Since they can only inject 1 cc, that has one-tenth the number of cells that a Regenexx physician could get in the same joint. Why? Our lab HD-BMC process can place all of the stem cells into small volumes. You also need small amounts to inject other areas, like low back discs, which can only hold about 1 cc. Also this is even a problem in a bigger joint, like a knee. While a knee can hold all 10 cc, if the doctor can get all of the cells in 2–3 cc and inject that, he has injected 3–5 times the concentration of cells per cc. Think about it this way. You can put two tablespoons of sugar in your iced tea. If you have a large volume of tea to sweeten (let's say a quart), your tea won't be very sweet. If you have only a glass, your tea is sweeter. Hence, we intuitively know that concentration of something (like stem cells or sugar) can make a big difference in the final product. At Regenexx we do it very differently. We process BMA by hand because we know how important it is to be able to customize the concentration to what the patient needs. So if the patient only needs 1 cc injected into his or her thumb joint, then we can concentrate all the stem cells into that 1 cc. Let's say the doctor needs 5; then we can put them into 5. On the bedside centrifuge side, meaning the little machines that doctors have, all you get is 10, so it doesn't matter if you only need 1, you get 10. If you need 5, you get 10. This means lower concentrations of stem cells, and that's the problem with the one-size-fits-all machine. Once we've completed the process, we can turn our focus to the final step: the reinjection.

The Reinjection


So we have our multiple-site draw, and we've processed our stem cells into an HD-BMC. Our next step is to reinject the patient's stem cells into the affected area. We do this by precisely targeting the areas that have problems. This is a very advanced technique that requires lots of training on image-guided injection using ultrasound or fluoroscopy. Most physicians perform this step blindly, meaning without guidance showing them precisely where to inject. Regenexx physicians, on the other hand, use imaging guidance, and this allows us to not only be sure we are injecting into the precise location but also provides us with additional diagnostic capabilities, which you can see in this link to a video of Dr. Pitts performing an actual stem cell procedure. It also means that we maximize the number of cells in the damaged area. It's important to note that the average family doctor, nurse practitioner, or orthopedic surgeon doesn't know how to perform these complex image-guided procedures. In fact, much fewer than 1% would understand how these are done. Also, while the average doctor performing spinal injections using fluoroscopy may have a good idea of how to inject the spine, he or she has never been trained in how to inject joints like knees, hips, and shoulders using ultrasound. The upshot? At Regenexx, everything is different...from how to take the cells to how we process the cells to how we reinject the cells. And that means a better outcome for you.

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