Amniotic “Stem Cell” Injections – Fact or Fiction?

What to Ask at an Amniotic Stem Cell Seminar

Henry A. Stiene, M.D.

There’s no shortage of amniotic stem cell seminars these days. Open up a paper from any major city across the U.S. or do a simple online search, and you’re likely to see an advertisement by a clinic or chiropractic group promoting one. Some promise miracle life changes after “live stem cell” treatments for chronic pain due to arthritis, musculoskeletal injuries, disc issues, and so on.  For someone who’s lived in pain for a long time, this can be very appealing. So how can you tell if an amniotic stem cell treatment is legitimate? The answer is easy. Cryopreserved (dehydrated) amniotic products do not contain stem cells.

 

What Is the Stem Cell Source?

In other words, where do the stem cells come from for the injection? A valid source of stem cells for orthopedic use would be bone marrow or from fat or adipose tissue. Stem cells from fat need to be enzymatically activated through a process called SVR, which the FDA says we cannot perform in the US. If a clinic tells you their stem cells come from amniotic tissues, this is not a legitimate source.

If there were any living stem cells in donated amniotic tissues to be processed for orthopedic use in another patient, that would require an FDA designation as a cellular drug. This means that the stem cell products would have to go through lengthy and very expensive clinical trials in order to potentially qualify for approval. No such approval exists.

The nonprofit organization Interventional Orthopedics Foundation (IOF), as well as other major university labs, have tested these products and have yet to find any viable cells, which make sense since they are not regulated as living-cell products. In order for stem cell treatment to be beneficial, the cells must be alive and functional.

 

Does Your Amniotic or Cord Products Contain Stem Cells?

When umbilical cord blood, placental tissue, and amniotic fluid are in their natural state, they contain numerous living stem cells that can be used to treat many diseases. These products are in their natural state when a woman gives birth. Amniotic membrane–derived cells are gathered from the placenta of volunteers immediately after childbirth—tissue that would otherwise be discarded.

Once this tissue is cryopreserved (freeze dried), no stem cells survive.

Some components do, however, survive this process.

Growth factors present in amniotic products do have the ability to decrease pain and repair tissue and have been used to help wounds heal such as in diabetic foot ulcers.  Growth factors are natural substances that can help enhance tissue repair. However, an injection of an amniotic or cord product contains lower growth factor levels than what you would get with a far-less-expensive platelet rich plasma (PRP) injection. The growth factors in amniotic products are about 3 times above baseline that would be naturally found in platelets in the circulation.

In comparison, when we treat tendons, we concentrate PRP about 8-12 times above baseline, and for osteoarthritis, about 20 times baseline. Not only is a PRP injection less costly, but it will also provide fully functional platelets plus live and functional immune cells.

Also preserved is hyaluronic acid, which is the component in products such as Synvisc or Monovisc.  Substances that help fight bacterial and viral infections also survive the cryopreservation process and that is why these products can help wounds heal.

While cryopreserved amniotic products do have some benefits; they contain NO LIVE STEM CELLS.  Therefore, if claimed as such, it is simply not the truth.

Amniotic products do not come from the patient who is getting the treatment. When a person receives their own body tissue in the form of stem cells or PRP, there is no chance of tissue rejection or allergy. The product belongs to the patient who is receiving the treatment.

Below is a video that reviews the primary claims made by the leading amniotic stem cell provider Stem Cell Institute of America:

Where Is Your Published Research?

Thousands of research articles now exist world wide investigating the use of stem cells and PRP for orthopaedic applications. Much of this quality research has been done outside the United States. The reason for this is that the rest of the world can culture stem cells. What that means is after a patient’s own stem cells have been harvested, they are put in a culture medium, which greatly multiplies their numbers and they are then reinjected, alive, back into the same patient a number of weeks later. Non-cultured stem cells and PRP are however, the most widely studied live biologic products studied.

Research is lacking to support amniotic or cord stem cells for orthopedic use. These tissues, when alive do provide valuable treatments outside of orthopaedics.

Other countries are allowed to use live umbilical cord stem cells and that literature is published and often it works, but per FDA regulations we are not allowed to use live umbilical cord blood in clinical orthopaedic practice, but only for research purposes.

Clearly, it wouldn’t be possible to research amniotic or cord stem cells in orthopedic applications when there are no living cells in the products being advertised at these seminars.

While this explains the lack of research, it doesn’t stop these clinics from quoting research that isn’t pertinent to your specific treatment (e.g., research on living amniotic stem cells present immediately following birth).

 

Research quoted is often misleading

Many clinics will put research on their website that doesn’t pertain to the procedure you are being treated for or that is able to be used in this country legally. You may be informed about how a stem cell procedure worked for arthritis, but in reality, the study that is being quoted involves a treatment you would not be getting. Remember, in orthopaedics and regenerative medicine in this country, the only live stem cell sources currently are bone marrow and adipose tissue.  You also may be quoted about a study that involved cultured stem cells, which again, has no application to patients in the US.

Currently no supporting research exists for amniotic and cord stem cell use for orthopedic issues, and finding patient outcomes for such procedures would be unlikely since these are not FDA-approved live-cell products.

 

Who Is a Candidate and What is Your Failure Rate?

Ask them if you are a candidate for an amniotic or cord stem cell procedure. The amniotic stem cell folks want everyone at the seminar to sign up during the seminar. Yet candidates for a stem cell procedure should first receive a thorough physical exam and be graded good, fair, or poor so they can make an informed decision about their stem cell procedure. This also includes a review of x-rays, MRI, operative reports and other medical conditions that might affect the outcome. This screening process often determines if a patient is a candidate or not for a stem cell procedure.

Stem cell therapies, regardless of the stem cell source, do not work for every type and severity of arthritis. Existing research shows that stem cell therapy is less effective in severe hip arthritis, for example, than it is in knee arthritis.

Who Will Be Performing the Procedure?

The provider should be a licensed physician, an MD or DO. This certification qualifies the physician to perform these precise and complex injections properly. If the provider performing these injections is a physician’s assistant (PA) or nurse practitioner (NP), this is not appropriate. The injection itself is not always technically difficult, but a PA or NP does not have the training a physician has had to handle any issues that can affect the treatment outcome such as managing medicines that may need to be stopped or changed that could affect the stem cell’s ability to work once injected.

What Type of Equipment Do You Utilize During Procedures?

If the clinic is not using imaging guidance for their injection procedures, this means they are injecting blindly, or injecting under the assumption the stem cells will magically make their way to the proper location. Clinics should be using musculoskeletal ultrasound and/or advanced live-image fluoroscopy to pinpoint the precise location of their injections. In addition, a full surgical setup with equipment to measure vital signs is needed as well as oxygen, crash cart, and automated defibrillator in case of an emergency. A chiropractic office performing injections of amniotic and cord products may not have an advanced setup such as this.

Conclusion

The more aggressive groups market amniotic or cord stem cell seminars by taking out full-page ads in major newspapers or on popular websites, but these are nothing more than high-pressure sales events. If you are seeking an orthopedic stem cell treatment, these seminars may seem appealing, but they aren’t selling a legitimate product. If you find yourself in the grips of one of these aggressive seminars, make sure you ask the right questions and know what the right answers should be.