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What Makes the Regenexx Same Day Procedure Different?

POSTED ON IN Regenexx-SD Research Presentations/Publications BY Chris Centeno

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We’ve been pioneering this field of stem cells used to treat orthopedic problems since 2005. In that time, we’ve made several advancements to keep us way ahead of the pack. One of those advancements is our unique way of processing bone marrow aspirate for our Regenexx Same Day Stem Cell Procedure.

What is a bone marrow aspirate? The link will explain this in detail.

Almost all physicians who use bone marrow concentrate (a same day stem cell injection procedure) utilize automated bedside centrifuges to process the bone marrow aspirate (BMA) sample. The goal of this processing is to concentrate the stem cell containing fraction of the aspirate. The resulting mix of cells of that process is called “bone marrow concentrate” (BMC).

All automated machines use the same basic process to concentrate BMC—they capture the “buffy coat” with varying levels of efficiency. The buffy coat is a small, gray in color, middle layer that appears after the BMC has been centrifuged. Given changes in each patient’s hydration and hematocrit levels, it’s not hard to see that this layer may appear at differing heights in different patients.

Most of the automated bedside machines in use today account for this inter-patient variation by taking a large cut of sample above and below the buffy coat, reducing the total BMA volume from 60 cc to approximately 10 cc. Given that the size of the buffy coat in a 60 ml sample is usually 1–2 cc, this creates a concentration problem (i.e., 1–2 cc of active ingredient diluted in 10 cc). When the Regenexx group medical practice first began, our focus was also on capturing this layer. However, manually processing this layer in a laminar flow hood in a medical practice resulted in much higher concentrations, as the usual dilution we could accomplish was 1–2 ml of active buffy coat in approximately 3 ml of total BMC. Hence, what all that means is that the first version of our process was more advanced than automated bedside units because it produced an injectate with 3–4 times the concentration of the buffy coat active ingredient, over automated bedside systems.

In 2012, our group medical practice asked the question of whether it was possible to increase mesenchymal stem cell (MSC) levels even higher. We were able to find a second source of MSCs in Bone Marrow Aspirate that was being discarded. This is a proprietary discovery that is the subject of a patent application, so I will describe it with that in mind.

MSC LLD countThe chart entitled “P0 Counts” is a comparison of the MSC content of the two layers with the traditional buffy-coat (BC) isolation versus the new source (we call this LLD). As you can see, the differences in the number of MSCs obtained via colony formation after plating the buffy coat versus the LLD is stark. In all 7 patients tested, LLD MSC content significantly beats the buffy coat.

In addition, other studies performed in our Regenexx lab found that the MSCs in the LLDmRNA LLD levels were faster growing and more chondrogenic (more capable of cartilage repair) than those found in the buffy coat. For example, the graph entitled “Day 8 mRNA Levels” shows that the gene-expression panel associated with chondrogenesis is hugely upregulated in LLD cells, versus buffy-coat cells.

regSD plus knee OAWhen we added these two fractions together, we were now producing a BMC that had an MSC content that was reliably 5–7 times higher than what could be obtained via automated bedside centrifuges. In addition, given the orthopedic injury focus of the group medical practice, the fact that MSCs from the LLD are present is very important to us. However, we also sought additional validation that this new processing technique would translate into better clinical success. The graph entitled “Second Generation Regenexx-SD Procedure” represents a prospective registry comparison trial between the first-generation processing and the newer second-generation technique (BC+LLD). In treating knee osteoarthritis patients, the Lower Extremity Functional Scale (LEFS, functional improvement), Numeric Pain Rating Scale (NPRS, pain improvement), and self-reported percentage of improvement were all significantly better with an injection of the new processing technique containing more MSCs.

The upshot? What we do at Regenexx can’t be replicated by the doctors using bedside machines for processing your bone marrow. It’s unique!

    comments

    rich ridinger says

    Do you accept medicare and/or other insurance?

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    Chris Centeno says

    Rich,
    Unfortunately no stem cell procedures are covered by Health Insurance of any kind in the USA. The exams and some diagnostic workups are billable to Insurance, however.

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    James says

    What, if anything can be done in the months prior to stem cell therapy to maximize the amount (number) of stem cells in the BMA sample?

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    Jason says

    I was going to ask the same question as James. What can be done before the process to improve stem cell levels?

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    Shelby Jordan says

    Is you Austin facility open?

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    Paul says

    Is it important to use advanced formula regenexx prior to the stem cell procedure

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    Ervin M Marston says

    Hi i have bone on bone in both of my shoulders.I am useing 2 types of nsaids [Topical creams ] they are working on the pain most of the time.I also have shots in the shoulder joints every 3 months they help some.Am a military ret and have TRI-CARE FOR LIFE.WILL THEY COVER THE PROCEDURE ?? Ervin M Marston C/MSGT RET USAF

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    W Ingram says

    Yes, so it is presumably important to use advanced formula regenexx prior to stem cell procedure. Regretfully, that certainly doesn't seem a complete answer. Why? Simply, how much prior, 10 minutes, 10 days, 10 months? Please be more specific.

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    B Dolphin says

    Once again...health is for the wealthy

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    Linda lawera says

    I'm interested in doing my right knee it has bone on bone and the knee is curved I was wondering if there s anyway my knee can be straightened with this procedure. I had partial knee replacement on my left knee and it is no longer curved and its longer than my right knee after the surgery what can be done???
    Thanks Linda lawera

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    Gary says

    I have a rotator cuff tear in the suprasinatus does this procedure work on this tear?

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    Chris Centeno says

    Gary,
    Yes, we treat Rotator Cuff Tears regularly. Here is some information on how we treat this issue: http://www.regenexx.com/the-regenexx-procedures/shoulder-surgery-alternative/ And this is a very important read. http://www.regenexx.com/rotator-cuff-surgery-recovery-time-do-you-need-a-shoulder-acromioplasty-surgery/

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    About the Author

    Chris Centeno

    Christopher J. Centeno, M.D. is an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. He is board certified in physical medicine as well as rehabilitation and in pain management through The American Board of Physical Medicine and Rehabilitation.…

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