New Amniotic “Stem Cell” Review Paper: Misinformed or Misleading?

by Chris Centeno, MD /

amniotic stem cell review paper

One of the things that’s often hard for patients to understand is that when it comes to using stem cells for orthopedic conditions, the universities are way behind private-practice physicians. The good news is that we’re seeing some universities, like Stanford, Emory, and the Mayo Clinic, begin to embrace simple cell therapies. The bad news is that other universities are still way behind the average private-practice doctor in using these therapies. An example of that issue is a recently published amniotic stem cell review paper by physicians at Rush University in Chicago. These guys are likely well meaning, but they clearly have little knowledge of what’s not in commercially available amniotic tissues being sold on the market today.

What Are Amniotic Tissues?

While I’ve blogged on this topic many times, amniotic tissues are derived from the waste products of the delivery of a child—namely, the amniotic fluid that surrounds the baby as well as the birth sac and placenta. Given that these tissues are cheap and plentiful, they’ve been sold for many years for use in wound healing, neurosurgery, and ophthalmology. These same amniotic products have been more recently used in orthopedic injuries, despite a lack of data showing that they could help these problems. More concerning is that many physicians have been convinced by sales reps that commercially available amniotic tissues contain stem cells, but they, in fact, contain no live cells. Even more concerning is that many physicians extend this ruse to their patients, convincing them to spend big bucks on amniotic “stem cell” injections that, in fact, contain no stem cells.

Conflicts?

Before I read many papers, I always do a little snooping on the authors, just to see who they are, who they work for, and whether there may be bias in what they write. In this paper, they list 14 different companies that have funded research, paid royalties or speaking or consulting fees, or provided stock or stock options. While this isn’t automatically a significant conflict, three of the companies (NuTech, Arthrex, and Zimmer) make or vend amniotic tissues. Hence, the authors have conflicts of interest on this topic. Having said that, I run a large, international, medical-group practice that has chosen not to use amniotic stem cells, so some would say that I have the opposite bias.

The Familiar Amniotic Stem Cell Shuffle Is Alive and Well 

Here’s my big concern with this paper. While I expect the usual rank-and-file uneducated physician to make the mistake that commercial amniotic products contain living stem cells, I don’t expect university physicians to make that same mistake.

The problems in the review paper begin when the authors use this paragraph heading in the paper:

“AMNIOTIC MEMBRANES AS A SOURCE OF STEM CELLS”

While there is truth in this statement (i.e., amniotic tissues when they are living do contain a small population of stem cells), my antenna went up, as the paper is about using these tissues in sports medicine, where specifically no physician will be using live amniotic tissues but instead the nonliving tissues sold to doctors. To amniotic tissuesdrive that point home, the authors list a table of amniotic tissues their readers may purchase. So there’s little doubt that the authors are describing commercially available amniotic tissue products that could be used by sports-medicine physicians. Hence, the big question is whether the authors explain to readers at some point that the tissues they can buy don’t contain stem cells.

As I read on in the paper, the paragraph above didn’t explain the difference between live tissues and amniotic tissue products. The next paragraph just describes the different stem cell types, how they are isolated from amniotic tissues, and how they can differentiate into orthopedic tissues. Again no disclaimer. Finally, a section emerged that would surely contain the explanation:

“COMMERCIALLY AVAILABLE HUMAN AMNIOTIC  MEMBRANE–DERIVED  PRODUCTS”

However, this section was a disappointment, as while it explains that these commercially available tissues are processed differently and discusses the “known effects of AM processing on its mechanical, biological, and cellular properties,” nothing is said to make it clear to physicians that when they purchase and use these products, they are not using a “stem cell” product. Even more disappointing is this statement later in the paper, which only adds to the suggestion that there are stem cells in these products: “Three major strategies have been employed in these early studies: (1) using AM as a scaffold for bone marrow-derived mesenchymal stromal cell (MSCs), (2) using AM as a scaffold for delivery of chondrocytes, and (3) inducing AM-derived pluripotent cells toward a chondrogenic phenotype.” This last statement would make any reader believe that by using commercial amniotic tissues they are using an amniotic stem cell product.

While the authors up to this point in the paper don’t come out and directly state that commercially available amniotic tissues contain stem cells, they have come pretty close. I thought that would be the end of their flirting with the issue until I came across this statement: “In summary, AM offers promise as an alternative to collagen I/III membrane scaffolds for 2-stage cartilage repair and as a source of pluripotent cells that does not require a morbid harvest (such as a bone marrow aspirate or a cartilage biopsy specimen).” Yikes, they finally dropped the big one! They continue to insert both feet into their collective mouths with this additional statement: “Amniotic membrane–derived products have the advantage of minimizing the ethical issues shared by embryonic stem cells while still having the promise of an easily attainable population of pluripotent cells…” 

I was pretty dumbfounded by this amniotic tissue review paper. As I said, I expect private-practice physicians to make this novice mistake, but we all hold academic physicians to a higher standard. Having said that, most academic centers are way behind private practitioners when it comes to the deployment of regenerative orthopedic therapies, so maybe it’s not too surprising that these doctors don’t know that these tissues don’t contain live and viable stem cells.

The upshot? I’m hoping these academic surgeons just don’t know what they don’t know and like many other physicians they bought the hype generated by sales reps. Hopefully, this review of their review will prevent them from making this same mistake in future papers. In addition, while we’ve done the research to vet the claims of sales reps claiming that commercially available amniotic tissues don’t have live stem cells, I welcome any research these surgeons publish to the contrary.

Category: Latest News

Leave a Reply

Your email address will not be published. Required fields are marked *

6 thoughts on “New Amniotic “Stem Cell” Review Paper: Misinformed or Misleading?

  1. Alex Vance

    If these so-called stem cell producers can sell there “stuff” then why don’t u see if they will duplicate our(patient’s) individual stem cells and sell them back to u to use as if we had gone to the Cayman Islands.
    I know U can’t duplicate them yourselves (Dr. Leiber of Bradenton, FL Regenexx) told me why). But if those folks are duplicating something now, they may be able to do yours without checking why U got refused. I like to think out of the box and I’d sure like to avoid more pelvic withdrawals.

    1. Regenexx Team Post author

      Alex,

      There are all kinds of reasons why that wouldn’t work and why we would never do that, but from one out of the box thinker to the other, interesting idea!

  2. Daniel

    My wife has bilateral heel spur. According to her podiatrist, the spurs are wearing out her tendons and recommended FlōGraft®. As a skeptic, I began researching about amniotic fluid-derived allograft when I stumbled into Dr. Centeno’s blogs. If Dr. Centeno is correct about amniotic injections does not contain stem cells due to processing, I can only assume that the podiatrist has a vested interest in Flograft or he is information about amniotic injections comes from biased sales reps. Her Podiatrist did not recommend surgery, he claimed of a 6 month recovery period and recommended Flograft instead. As an ICU nurse, she can’t afford to be out that long anyway. As a Physical Therapy practitioner, I have tried my hand with the problem but the resulting relief was very brief. I am aware that Regenexx is different. However, I still have lingering doubts. Do you have any published information (outside of Regenexx) regarding the absence of stem cells in amniotic injectables? We are about to get a second opinion and Regenexx seems promising.

    1. Regenexx Team Post author

      Daniel,
      Bone spurs are the body’s answer to instability. When a joint or an area becomes unstable due to a lax ligament, more bone is manufactured to shore up the area by preventing the inappropriate movement. Heel bone spurs are most often caused by Plantar Fasciitis in which the Plantar Fascia Ligament on the bottom of the foot gets stretched, so discovering and treating the cause of the instability is crucial: http://www.regenexx.com/the-regenexx-procedures/ankle-surgery-alternative/ If the bone spurs are too large to resolve on their own, they can be broken up with a needle technique called Barbotage. There is a lot of research on live amniotic fluid and tissue, rather than the products marketed. The Interventional Orthopedics Foundation did the testing we refer to: http://www.regenexx.com/an-amniotic-stem-cells-challenge/

  3. Bulah Taylor

    I have lot the cushion in my extreme lower back between the SI joints, would any of the stem cell therpay help and if so, what kind?

    1. Regenexx Team Post author

      Bulah,

      We’ve used prolotherapy, platelet procedures and stem cell procedures to successfully treat the SI joint, depending on the individual situation. We’d need to examine you to advise what would be needed in your case. Please let us know if you’d like to do that.

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.
View Profile

Get Blog Updates by Email

Get fresh updates and insights from Regenexx delivered straight to your inbox.

Regenerative procedures are commonly used to treat musculoskelatal trauma, overuse injuries, and degenerative issues, including failed surgeries.
Select Your Problem Area
Shoulder

Shoulder

Many Shoulder and Rotator Cuff injuries are good candidates for regenerative treatments. Before considering shoulder arthroscopy or shoulder replacement, consider an evaluation of your condition with a regenerative treatment specialist.

  • Rotator Cuff Tears and Tendinitis
  • Shoulder Instability
  • SLAP Tear / Labral Tears
  • Shoulder Arthritis
  • Other Degenerative Conditions & Overuse Injuries
Learn More
Cervical Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
Learn More
Knee

Knees

Knees are the target of many common sports injuries. Sadly, they are also the target of a number of surgeries that research has frequently shown to be ineffective or minimally effective. Knee arthritis can also be a common cause for aging athletes to abandon the sports and activities they love. Regenerative procedures can be used to treat a wide range of knee injuries and conditions. They can even be used to reduce pain and delay knee replacement for more severe arthritis.

  • Knee Meniscus Tears
  • Knee ACL Tears
  • Knee Instability
  • Knee Osteoarthritis
  • Other Knee Ligaments / Tendons & Overuse Injuries
  • And more
Learn More
Lower Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
Learn More
Hand & Wrist

Hand & Wrist

Hand and wrist injuries and arthritis, carpal tunnel syndrome, and conditions relating to overuse of the thumb, are good candidates for regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Hand and Wrist Arthritis
  • Carpal Tunnel Syndrome
  • Trigger Finger
  • Thumb Arthritis (Basal Joint, CMC, Gamer’s Thumb, Texting Thumb)
  • Other conditions that cause pain
Learn More
Elbow

Elbow

Most injuries of the elbow’s tendons and ligaments, as well as arthritis, can be treated non-surgically with regenerative procedures.

  • Golfer’s elbow & Tennis elbow
  • Arthritis
  • Ulnar collateral ligament wear (common in baseball pitchers)
  • And more
Learn More
Hip

Hip

Hip injuries and degenerative conditions become more common with age. Do to the nature of the joint, it’s not quite as easy to injure as a knee, but it can take a beating and pain often develops over time. Whether a hip condition is acute or degenerative, regenerative procedures can help reduce pain and may help heal injured tissue, without the complications of invasive surgical hip procedures.

  • Labral Tear
  • Hip Arthritis
  • Hip Bursitis
  • Hip Sprain, Tendonitis or Inflammation
  • Hip Instability
Learn More
Foot & Ankle

Foot & Ankle

Foot and ankle injuries are common in athletes. These injuries can often benefit from non-surgical regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Ankle Arthritis
  • Plantar fasciitis
  • Ligament sprains or tears
  • Other conditions that cause pain
Learn More

Is Regenexx Right For You?

Request a free Regenexx Info Packet

REGENEXX WEBINARS

Learn about the #1 Stem Cell & Platelet Procedures for treating arthritis, common joint injuries & spine pain.

Join a Webinar

RECEIVE BLOG ARTICLES BY EMAIL

Get fresh updates and insights from Regenexx delivered straight to your inbox.

Subscribe to the Blog

FOLLOW US

Copyright © Regenexx 2019. All rights reserved. | Privacy Policy

*DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.

Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.