Advanced Bespoke Orthobiologics: Why Settle for One Size Fits All?

by Chris Centeno, MD /

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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 eventsit 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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13 thoughts on “Advanced Bespoke Orthobiologics: Why Settle for One Size Fits All?

  1. DIANE FAY

    SOUNDS LIKE IT MAKE SENSE!….ALL OF DIFFERENT NEEDS WE HAVE TO BE EVALUATED INSTEAD OF A ONE SIZE FITS ALL..

    1. Regenexx Team

      Diane,
      Yes!

  2. billie swafford

    I think it makes a lot of sense also and needs to be affordable so lower class hard working people can have a chance at it. So they can get back to work, and off pain medication so the pharmacutical company’s are not running the show.

    1. Regenexx Team

      Billie,
      The Insurance Industry still considers Stem Cell Therapy experimental. We continue to do research and publish the results in peer reviewed journals. At some point their position will hopefully change, making stem cell therapy more accessible.

  3. David

    What if a patient has bone spurs along with bone-on-bone in my shoulder joints? Can that person be a candidate for stem cell treatment? Can you get rid of the bone spurs before you inject the stem cells?

    1. Regenexx Team

      David,
      Yes. While determining Candidacy is a specific process, our research has shown that a joint being bone on bone does not affect outcome of our Stem Cell procedures. Bone spurs are your body’s way to stabilize an unstable joint, so first the cause of the instability needs to be determined and treated. http://www.regenexx.com/blog/shoulder-instability-recovery-time/ https://regenexx.com/blog/bone-spur-pain/ If the bone spurs don’t dissipate on their own, they can be dissolved using a needle procedure without surgery, but as to whether that should be done first in your case would be for the doctor to determine. http://www.regenexx.com/the-regenexx-procedures/shoulder-surgery-alternative/ If you’d like to discuss your situation with one of our Doctors, please fill out the Regenexx Candidate form.

  4. Joyce

    This explains why my orthopedic sugeon doesn’t recommend PRP or stem cell therapy. I was told theses therapies do not “heal” or reverse osteoarthritis, just delay joint replacement. If they are using “one size fits all” approach, they are doing a disservice to their patients. I attended a Mayo Clinic webinar yesterday, but they also indicated these therapies tend to work only for younger patients. Maybe they need to insert customization into their trials.

    I am currently waiting for a call back from your Toledo, OH center to discuss my needs for hip osteoarthritis.

    Keep up the good work and research Regennex. The world needs you!

  5. Stella Eargle

    Notice that Joyce stated it was indicated these procedures worked only young people. Is this accurate?

    1. Regenexx Team

      Stella,
      Not at all. We treat people of all ages and our research shows that age not does not impact outcome. http://www.regenexx.com/blog/regenexx-research-review/ Dr. Centeno’s answer was specific to “hip arthritis in patients over 55”, which is the ONE category in which there is often less robust outcome.

  6. Eileen Steere

    You spoke of bone spurs in one of the comments in responses. Do they aspirate bone spurs or how is it performed?Can this be done without sleep like anesthesia or , again, how is it done? Sounds fascinating.

    1. Regenexx Team

      Eileen,
      Your body creates bone spurs in an attempt to stabilize an unstable joint, by “growing” extra bone to prevent motion in directions it’s not supposed to move in. So the instability that caused the bone spurs to form is what needs to be treated. If the bone spurs need to be removed they can be by a technique called Barbotage which is a needle based procedure: http://www.regenexx.com/getting-rid-of-a-bone-spur-with-a-needle/

  7. Eileen Steere

    So joint instability, how can that be remedied with stem cells or is it more of a age related issue?

    1. Regenexx Team

      Eileen,
      Laxity can be caused by age, injury, dislocation. Once the lax ligaments or tendons causing the joint instability are identified by exam (both physical and ultrasound), they are treated with precise injections of platelet rich plasma, (Regenexx-SCP) and if the instability is more severe, then stem cells (Regenexx-SD), restoring the integrity of the lax ligament or tendon.

Chris Centeno, MD

Regenexx Founder

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications.
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