Which Amniotic Product Do We Use?

POSTED ON 2/18/2018 IN Regenerative Medicine Education BY Christopher Centeno

amniofix regenexx

Because our research demonstrated the widespread fraud that's going on in the amniotic and cord blood industries with claims of live stem cells in dead products, many have figured I hate these products or have something against them. Nothing could be further from the truth. However, we have strict rules at Regenexx. One is that we NEVER believe a sales rep or any white paper distributed by a company trying to sell something. Second is that we test all products ourselves in our own advanced-lab facility to see if they perform and meet our specs. This is why we chose to add the MiMedx product AmnioFix to our Regenexx clinics.

Don't You Hate All Amniotic and Cord Products?

In short, no. I like any product that may help patients. At the same time, what I won't put up with is orthopedic sales reps pulling the wool over the eyes of physicians who should know better. In the case of amniotic and cord stem cell products, our research and that eventually taken over by the IOF demonstrated that these products have no living cells. That's juxtaposed to dishonest companies claiming ridiculous live stem cell counts. See my video below to learn more: [dk-video id="WOd0RVlfNh4" autoplay="false" button="white" title="" show-title="false" width="70%" align=""]

How Do These Products Work if They Don't Have Stem Cells?

We just finished the annual Interventional Orthopedics Foundation conference, and one of the great lectures was by Steven Badylak, MD, PhD, DVM from the McGowan Institute for Regenerative Medicine. He discussed one mechanism that explains how ECM products work. What is an ECM product? ECM stands for extracellular matrix. The cells in your body make their own ECM that's different and unique for all tissue. This is the stuff that they live in. For example, bone cells (osteocytes) make a mineralized mix of collagens that assembles to become bone. Chondrocytes make a compressive and shock-absorbing mix of collagens and glycosaminoglycans (GAGs) that becomes cartilage. Finally, tenocytes make a stretchy mix of collagens that becomes a tendon. So an ECM product is the stuff that cells make without the cells.

While amniotic products don't have live stem cells and their traditional orthopedic growth factor levels are low compared to even a simple platelet rich plasma, they do have two interesting things going for them. First, they may have unique cytokines and growth factors that may help tissue healing that we don't understand. Second, and likely more important, is that they are likely an all-purpose ECM.

Dr. Badylak's talk was amazing in that he demonstrated how various ECM products helped change the environment for healing. Basically, they were able to take local macrophages (the cells that help repair by taking out the garbage) to go from an M1 state (pro-inflammation and breakdown) to an M2 state (pro-growth and repair). So the efficacy of amnion may be more about its ability to shift a chronic injury site from scarring, swelling, and poor repair to lower inflammation and repair. Meaning that it may have nothing to do with stem cells or even high levels of native growth factors within the products.

See my video below for more info on how stem cells can turn bad macrophages into good ones: 

Why We Chose MiMedx

As I have blogged, most amnio companies are still pushing a bait-and-switch stem cell scam to drive sales. They also have not invested a dime in clinical studies. MiMedx is different. First, they gamma terminally sterilize their products, so they freely admit that they have no stem cells or other living cells. Second, they have a robust clinical-trials pipeline testing their products for a variety of orthopedic conditions. See below: However, there's an even bigger reason we chose this company's amnio product for our Regenexx network clinics. Of all of the amnio products we tested in our advanced research lab, this one performed the best. Which is why patients choose Regenexx. We test everything to make sure that what we give our patients is the absolute best out there.

Our Flexible Orthobiologics Platform

Our Regenexx providers have the ability to offer patients every possible orthobiologic being used today. This includes advanced platelet rich plasmas at any concentration or configuration. Fourth-generation platelet lysates, which are growth factors stripped from blood platelets to act as an "immediate release" regenerative cocktail. Advanced bone marrow concentrate or microfractured fat procedures. They can also deploy a number of cytokine-enriched serums, which are anti-inflammatory and possibly anti-breakdown. Finally, we are incorporating a number of ECM products, of which the best-in-class AmnioFix product is the first.

If you go outside the Regenexx network, what do you get? You get whatever some sales rep was able to sell a doctor. CAUTION, scientific reality may have been suspended to make the sale! These physicians won't have a flexible lab platform to deploy customized biologics to help you heal. They will only be able to provide the "one size fits all" biologics that the simple bedside machines they bought create. Meaning instead of a Ferrari, you may get a moped.

The upshot? We're proud to add MiMedx products to our Regenexx network sites. The main AmnioFix product passed our rigorous testing parameters, and also important, the company isn't involved in a bait-and-switch scam to have providers believe that they are selling live stem cells in vials. The company has also invested tens of millions of dollars in clinical trials, which makes them right up our alley!    

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