Do they have a role in Orthopaedics and Sports Medicine?
Henry A. Stiene, M.D.
Cryopreserved biologic amniotic tissue has an emerging role in orthopedics. However, it is important to understand that stem cells are not contained in this product.
There is good evidence that these products can be very beneficial in treating plantar fasciitis and other tendon problems. Along with other types of injection therapies, amniotic products have shown to be of benefit in athletes of all ages due to overuse injuries.
They can also be used in conjunction with Regenerative Medicine treatments such as stem cells, PRP, and prolotherapy to help improve outcomes or for those patients that have only had a partial response to stem cells or PRP. They are also a very good option for patients who are taking multiple medicines, such as blood thinners. Patients do not have to stop these and other medicines when treated with amniotic products.
Currently, there are also ongoing research trials for amniotic products in osteoarthritis for patients who are not candidates for PRP or treatment with their own stem cells. They are also a safe option for patients who are at high risk for complications due to total joint replacement because they have heart or lung disease or have had blood clots from other surgical procedures. It is important to understand how this treatment can help patients, but it is also very important to understand what it is “not.”
Amniotic products do not contain stem cells so if you are going to a “stem cell seminar” please continue to read below.
What to Ask at an Amniotic Stem Cell Seminar
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.
Do 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—the 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 similar to those found in PRP survive the process as does hyaluronic acid which is found in Synvisc, Monovisc, Orthovisc, etc. They also have some proteins and substances that lead to tissue repair and healing that are not found in PRP.
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 contain the HLA antigen which is a marker that allows your body to identify that a substance is foreign so allergic reactions are extremely rare and have not been reported with the use of the product Amniofix. Prior to undergoing cryopreservation the tissue is screened and tested for hundreds of infectious agents and if any are found the tissue is discarded.
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 orthopedics 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.
Who Is a Candidate and What is Your Failure Rate?
Ask 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 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 set up 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.
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 a Regenerative Medicine Treatment, these seminars may seem appealing, but they aren’t being completely truthful about the 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.