MiMedx and AmnioFix Review

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This book kept staring at me. It’s been sitting on my office desk for the last month plus, taking up a huge amount of space and doing a good job of standing out when compared to my patient charts. You see, it arrived in the mail in a big FedEx box. What is it? It’s a bunch of research studies about amniotic and placental tissues. Why was it sent? I’m a bad boy…

What Are Amniotic and Placental Tissues?

I’ve written a great deal about our amniotic stem cell problem (also our placental stem cell problem). These are birth tissues that have been sold for a long time. Just five to seven years ago, they were merely one of many tissues that were used in surgery. Because the amniotic membrane of a baby (birth sac) looks a lot like the covering of the spinal cord (dura), neurosurgeons used to have a nurse grab the afterbirth from the labor and delivery ward to sew it into a traumatic defect in the dura. Fast forward to the 1970s when law changes made that impossible and the tissue-banking business was born. These companies were able to inexpensively register tissues with the FDA (unlike a long and arduous drug-approval process), and some of these were the products that could be made from the afterbirth (the amniotic membrane, placenta, etc.). These tissues were slow and steady sellers, as, after all, how many times in the U.S. each year does a neurosurgeon need to repair a large defect in the dura?

Then about five to seven years ago, something called PRP (platelet rich plasma) happened. While PRP had been used for many years in dentistry, all of a sudden it began to be more widely used to treat orthopedic problems. There was just one little problem with PRP: doctors had to have someone draw blood, put it in a machine, and then inject it, all in the same day! Oh, the horror of all that work and coordination! Hence, a market niche was born. Could someone come up with a product that could sit on the shelf that would be like PRP—an injectable that would have growth factors to help healing? The amniotic- and placental-orthopedic-tissue industry was born!

I remember seeing my first AmnioFix booth (a product made by MiMedx) at a conference in about 2010. I wasn’t sure at first what they were advertising, but I soon found out that they had dehydrated birth tissues that were chopped finely so they could fit through a larger needle for injection. Most of the physicians I spoke to who had tried it were unimpressed as it caused a severe inflammatory reaction in many patients. Others liked it as a product they used rarely to help close big gaps, like a large retracted-tendon tear.

Sometime around three to four years ago, a real problem occurred that has (IMHO) done more damage than good to the regenerative orthopedics space—”amniotic stem cells.” You see, this dehydrated tissue wasn’t a blockbuster product, so a few companies began selling amniotic fluid and these sales also lagged. However, some smart sales rep somewhere got the bright idea that since stem cells were beginning to take the orthopedic-care world by storm and amniotic fluid has a low concentration of stem cells when it’s fresh, then they were really selling a stem cell product! There was, of course, one little problem—by the time their product had been irradiated, frozen, and shock-thawed in a doctor’s office (not to mention dehydrated in the case of some MiMedx products), it had few to no living cells, let alone stem cells. However, the doctors who were falling for this bait and switch were not educated in cell biology, so they bought the ruse hook, line, and sinker. There’s a sucker born every minute!

As I’ve blogged before, we’ve now tested many of these amniotic “stem cell” products in our lab and have confirmed that they contain no live stem cells. This comes as a surprise to patients and the gullible docs who buy this stuff, which is why I have this book on my desk!

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I Am a Bad Boy, so They Sent Me a Book to Rehab My Mind…

As I said above, most doctors buying the “amniotic stem cell” bait and switch don’t know what they don’t know. They have no cell-biology training. I, on the other hand, began using stem cells when there were no courses and no books to read. Hence, I had to know a lot about the cell-biology side to pull off being the first in the world to use stem cells to treat a long list of orthopedic conditions or first in the U.S. for others. Which is again why I have this damn book on my desk.

Unlike many of my colleagues who are happy to listen to sales reps and who often buy what they’re selling, we have a million-dollar lab staffed with a research team that has all of the bells and whistles of any university stem cell lab. So when they make claims, we test them. If they pass with flying colors, we’re more than happy to buy their products and use them in our patients; if they fail, then we’re more than happy to let everyone know that product X didn’t live up to its hype! Which is why I get to stare at this huge book on my desk.

Stem Cell Factors—the Bait and Switch Morphs…

Once the birth-tissues industry was faced with our lab-based studies showing that these products didn’t have any living cells, let alone stem cells, the sales pitch morphed. The new term I heard being used was that they were “stem cell factors.” The reps still got to use the “stem cell” term that made these things sell like hotcakes, and the “factors” was a reference to the growth factors in them that helped healing. The problem was, of course, most of these growth factors had little to do with the stem cells that once lived in these products. The other even bigger problem was that our lab testing showed that the growth-factor levels in these amniotic and placental products that an orthopedic specialist might be interested in were a fraction of what a less expensive and less risky PRP shot contained. However, it’s this new push to reclassify these products as growth-factor-rich cocktails that has caused this darn book to have implanted itself on my desk.

What’s in the Book?

The book title is a “Clinical and Scientific Data Compendium” of MiMedx placental products. These are parts of the human placenta that have been dehydrated or packaged and either kept whole or ground up for injection or sprinkling on a wound. This book makes no claims of live stem cells. The book has many scientific studies. I can summarize its contents as follows:

  1. A book chapter explaining what these tissues are and how we think they work to help healing
  2. A bunch of abstracts and matching studies that almost all focus on healing skin wounds (like diabetic ulcers)
  3. A section to help us doctors understand statistics
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What’s the Problem with the Book and Placental Tissues in General?

If I had a practice full of patients with diabetic foot ulcers, the research in the book would be very interesting to me. However, my patients have knee, hip, or shoulder arthritis or rotator cuff tears or back/neck pain. There is one small study in the book on plantar fasciitis and one on low-back surgery, but outside of that, there’s nothing in the book that directly applies to my patients. This is the problem as I sit here in 2016—there is limited research on amniotic and placental tissues that shows that these help orthopedic problems.

In addition, even if something became available, the big question would be whether a much less expensive PRP shot would do as well as the much more expensive vial of birth tissues. It had better be at least as good or better, as with PRP that comes from the patient, I don’t have to worry about putting foreign tissue in my patient’s body. Might I use this product at some point in the future? It’s possible, but that would take some convincing.

The upshot? First, I am so glad I got that damn book off my desk! Its stares had been turning into glares, daring me to read the amniotic and placental wisdom within! It now lives safely in my circular file with yesterday’s lunch. Second, the idea that what began as a bait and switch to sell birth tissues as a stem cell product can now credibly be morphed to the idea of “stem cell factors” doesn’t really hold water, based on our research. In addition, there’s nothing in the book that would make me think much differently. Third, there’s little research to support that these tissues help orthopedic problems, and even if we get some, the huge question is whether these tissues would perform any better than a simple PRP shot. That doesn’t mean I might not use them someday. In conclusion, my mental remediation to align my thoughts with the burgeoning business of selling birth tissues as magic stem cell products has been unsuccessful. Right now, I feel an awful lot like that Olympic athlete Apple had throw that sledgehammer at the Big Brother screen in the iconic 1984 commercial!

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. View Profile

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