Advanced Bespoke Orthobiologics: Why Settle for One Size Fits All?
POSTED ON 3/21/2016 IN Regenerative Medicine Education BY Christopher Centeno
One of things I take for granted that most patients or physicians never experience is the fact that we heavily customize stem cells and platelets to match what the patient requires. You see, 99% of what gets injected at clinics outside of our Regenexx Network is one size fits all. Kind of like that T-shirt they hand out at events—it comes in XXL only, which may work well for some people but not so much for most.
What's Done Now?
First, the term orthobiologics covers a broad array of things used to help heal or manage orthopedic injuries. This includes platelet rich plasma (PRP) and all of its offshoots, stem cells, extracellular membrane, and cytokine products. Most PRP and stem cell procedures involve the use of an automated bedside centrifuge to concentrate the blood or bone marrow. For fat stem cell procedures, the adipose tissue is processed in a hood using a script called an "SOP." In almost all of these cases, what the doctor gets to treat the patient is a one-size-fits-all product. For example, a 20-year football player with an ACL tear, a middle-aged athlete with a rotator cuff tear, and an 78-year-old woman with knee arthritis all get the identical orthobiologic cocktail.
Why It Makes Sense to Customize the Biologic to the Problem
One of the more obvious reasons that this one-size-fits-all approach is not ideal is age. For example, we know that older patients, regardless of what type of stem cell therapy they receive (i.e., bone marrow or fat), have fewer stem cells per unit volume of treatment than their younger counterparts. The same holds true for the growth factor content of platelets, which declines with age. So it makes little common sense that a 20-year-old should have the same dose of either of these orthobiologics as an 80-year-old, but that's what happens every day in clinics across the world. Why? The automatic bedside machine that doctors use usually can only process one volume of blood or bone marrow and output one dose of concentrated cells. Some have different kit sizes, but that only adjusts the volume and not the concentration of the end product. There are a few rare machines on the market that can adjust the dose of PRP, but I've never seen one for stem cells. Some doctors will try to use a kit meant for a single use twice to see if they can jigger the device to produce something different, but once they do, they're outside of the specs for the machine, and it's often unknown what's produced.
While age is an one issue, how about the target tissue to be treated? One problem that doesn't get adjusted for is the size of what's being injected. For example, a knee might be able to be injected with a few cc's of injectate, but a low-back disc can only hold 1 cc max. Why is this an issue? For example, if the brand of bone marrow concentrator being used always produces 10 cc, a knee may get a full dose (if you can get 10 cc in the joint), whereas a disc will only get one-tenth of that dose! In addition, the knee will get one-third of the stem cell concentration of another doctor's who could concentrate all of those same cells into 3 cc, so while the dose is full, the concentration is off!
What about different concentrations or technologies for different tissues? For example, based on numerous studies, we know that red PRP (which has red and white blood cells) causes significantly more inflammation and swelling than amber PRP, which would make it a poor candidate to use around nerves; even amber PRP (which is red- and white-blood-cell poor) causes some swelling, but in our experience platelet lysate (a solution created by extracting growth factors from platelets and then eliminating the platelet cells) is generally anti-inflammatory, which makes it ideal to use around nerves. On another note, higher concentrations of PRP likely aren't ideal for tendons, but in our experience and in-vitro testing, they're likely ideal to use in the joints of older patients. Again, the problem is that the one-size-fits-all nature of what's offered at 99% of the clinics can't match the product to the tissue being targeted.
What's Different About What We Do? Advanced Bespoke Orthobiologics
At Regenexx, we have long since solved all of these issues. A few months ago, I looked at the surgical tray for an injection in a complex patient. I had two different concentrations of our type of PRP (SCP)—a low dose for the patient's tendons and a high dose for an arthritic joint. I also had a higher concentration of platelet lysate to use for an epidural injection (given the patient's advanced age) than I would use in a younger patient. I also had two concentrations of a same-day stem cell mix (Regenexx-SD)—one at 2 cc at a higher concentration for the knee and one at 1 cc at an ultra-high concentration for a low-back disc. As I looked at all of this and thought about almost every other clinic where this patient could have ended up, I realized that what he would have gotten was a one-size-fits-all biologic. There would have been no adjustment for his advanced age and none for the different tissues being injected. Last, the concentration of same-day stem cells for the disc and knee would have been the same, robbing his disc of 90% of the stem cells that could be used and robbing his knee of one-third of the possible stem cells (assuming the most common volume produced by simple automatic machines at 10 cc).
The upshot? At Regenexx we only use advanced bespoke biologics. These are always customized to match the age and health of the patient as well as the tissue and area that we're targeting. Outside of our network of physicians, you're very unlikely to get this type of customized care, as in that world, one size fits all is good enough.
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