Amniotic derived products are proliferating like zombies in the regenerative medicine world. So, what are those amniotic injection products? Amniotic fluid is produced during pregnancy. This fluid is surrounded by a membrane that forms like a sack or balloon, covering the fetus. Just before birth, this sack breaks and the fluid comes out. This is what people refers as “the water breaks”. This amniotic membrane and fluid contain stem cells and growth factors, so it is now being processed and marketed by several companies that buy them from tissue banks. The amniotic membrane is processed by freeze drying it and pulverizing it. It then sold as a powder in little vials, to be reconstituted at the doctor’s office before getting injected. This process kills all the cells that were alive in the membrane. As a matter of fact, the FDA approval for these products specifies that these are an extracellular matrix with NO live cells. Otherwise, these products would be considered “drugs” instead of “tissue” and the FDA would then require extensive and expensive clinical trials in order to approve them.
So, if all the cells that were originally in these membranes are killed, why are they useful for the treatment of musculoskeletal conditions? They can be useful because they contain a number of growth factors that help in tissue healing, much like platelet rich plasma (PRP) does. But, unlike PRP, these products have to be purchased (at steep prices), resulting in a significant cost increase when compared to PRP.
Unfortunately, trying to capitalize on the increasing popularity of stem cells in the treatment of musculoskeletal conditions, these amniotic derived products are being widely marketed as “stem cell therapy”. This is done mostly by the sales reps selling these products and by orthopedic surgeons using them. As we explained above, when the amniotic membrane or fluid is processed and put in little vials for selling, all the cells are killed. As a matter of fact that is a requirement due to the FDA approval process for these products. So, how can this be a “stem cell therapy’? Well, it’s not.
When these products are being marketed as “stem cell therapies’ someone is being lied to: either the FDA or the patients. The FDA is monitoring this and it has issued several warning letters to manufacturers of amniotic derived products due to their misleading marketing techniques. That has resulted in several of these companies issuing statements that their products contain no viable cells. The fact that these products contain no live cells is something that was confirmed by an independent lab from the Interventional Orthopedics Foundation. They tested several of amniotic product and found no living cells. But, that doesn’t prevent many of the clinics using these products to keep marketing it as “stem cell therapy” to a public that doesn’t understand the difference.
Be smart. If you are looking into stem cell therapies, and come across any of these clinics using amniotic derived products using deceptive marketing techniques, keep looking. If you find a clinic you like, ask them where the stem cells come from. The only way you can get stem cell therapy, with real stem cells, in the USA is if those cells have been harvested from your own body.
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