The simple reason we don’t use, and nobody should use, amniotic or cord blood “stem cells” for orthopedic treatments is because these products contain no living stem cells. Yet it’s possible that you’ve seen other clinics, such as some chiropractic clinics, pushing amniotic “stem cells” as a treatment for musculoskeletal conditions. What they aren’t telling you, unfortunately, is that the stem cells are dead. Watch Dr. Centeno’s video below for a good explanation of this:
So how do we know these amniotic products don’t contain living cells? We don’t use products we don’t test first, so we and other third-party entities (meaning testing that isn’t sponsored by the company manufacturing the product) have tested them. Before we expand on this, let’s first examine how these amniotic and cord blood products are made.
Amniotic and Cord Blood Products and How They Are Made
There are many birth tissues that are discarded after the delivery of a baby. These include the umbilical cord, the amniotic sac and amniotic fluid (the sac of fluid the fetus lived in as it developed), and placental tissues. While it would be very exciting if these tissues did contain stem cells that could remain viable after processing and be used for orthopedic treatments, unfortunately, they simply do not.
Do birth tissues contain stem cells? Yes. The Wharton’s jelly inside the umbilical cord and the amniotic fluid does contain living stem cells in the fresh birth tissues. However, in order to use these tissues for interventional orthopedic procedures, a great deal of processing is involved. Processing amniotic tissue to create a product can include any number of steps, including the following: chopping the tissues, sterilizing, freezing, storing, shock-thawing, placing in a vial or drying into a powder form, shipping, storing some more, and so on. Whether the amniotic product at this point is in a vial of liquid or powdered (believe it or not, you can’t just add water to a dehydrated amniotic product and magically raise stem cells from the dead), the amniotic stem cells are no longer living.
Testing Finds No Living Cells in Products Claiming Amniotic Stem Cells
The Interventional Orthopedics Foundation (IOF) has tested products claiming to contain amniotic stem cells for stem cells. What did they find? Or better yet, what didn’t they find? First, they didn’t find any living stem cells in these products. Second, they also found that the products did not help the performance of older stem cells, something often claimed. Finally, the amniotic products that have been tested, while they do have some growth factors, they weren’t found to have any more growth factors than a platelet-rich plasma (PRP) injection.
Is there any benefit to the growth factors in these products claiming to contain amniotic stem cells? The growth factors may provide some benefit; however, an injection of growth factors isn’t the same thing as a stem cell treatment. And you aren’t actually getting a stem cell treatment if the amniotic “stem cells” in the product being injected are dead. Why pay for an amniotic “stem cell” injection, which only actually contains some growth factors and no living stem cells, when a simpler and less expensive PRP injection is just as, or more, effective?
It’s also important to note here, testing aside, that while these amniotic products are FDA registered, this is not the same as an FDA approval to use a live stem cell product. These products asserting they contain amniotic stem cells have a simple 361 tissue registration process through the FDA that only involves a quickie 45-minute online form completion. A 361 registration requires no data or clinical trials. In fact, if these amniotic products indeed contained any live cells, the FDA would consider them to be a drug, which requires a 351 cell-drug approval. In order to get this, the product would have to go through 5–10 years of clinical trials costing hundreds of millions of dollars to complete. Learn a lot more about this by watching Dr. Centeno’s brief video below:
We don’t use amniotic “stem cells” for orthopedic treatments because thanks to our own testing, the IOF testing, and our knowledge and understanding of the FDA registration and approval process, we know these products are dead cell products. Even if a clinic doesn’t have a state-of-the-art lab like ours here at the Centeno-Schultz Clinic to test products before they consider using them on their patients, there is so much information out there now showing there are no living stem cells in processed amniotic and umbilical cord products. At this point, any provider offering an amniotic “stem cell” treatment for orthopedic conditions has gone beyond lacking the knowledge to know better. Charging for and calling a procedure a stem cell treatment that is actually just an injection of some growth factors is a scam.