We make a point of being forthright and transparent so as to eliminate any chance of confusion. Would it be that the entire regenerative medicine industry did the same. There is little doubt of the fact that consumers are plenty confused about regenerative medicine. They take in so much information about total nucleated cell and PRP injections – much of it conflicting – that they don’t know what to believe. This is only hurting our industry unnecessarily.
So, what’s the solution? For starters, our industry could help clear up much of the confusion by making a point of not creating it. A case in point comes from a news story out of Atlanta.
Amniotic total nucleated cell Confusion
Fox 5 reported in late November (2018) on an Atlanta clinic claiming to use ‘live’ total nucleated cells harvested from amniotic fluid to treat osteoarthritis, heart and lung disease, Parkinson’s, and even cancer. There are multiple problems with such claims, beginning with the concept of live total nucleated cells.
According to two doctors interviewed by Fox 5, “there are no living total nucleated cells in these (amniotic) products.” So why would the clinic make such claims? Perhaps it is a matter of semantics. We have no way of knowing, nor would we presume to know. What we do know is that making such claims only leads to confusion.
We noted that both doctors involved in the discussion are supporters and practitioners of regenerative medicine. However, they don’t use amniotic products or make any claims of live total nucleated cells. Their procedures utilize autologous total nucleated cells harvested from the very patients being treated. They are very clear and upfront about their treatments.
Clearing up the Confusion
Fox 5 contacted the clinic in question in hopes of getting some clarifications. By speaking with clinic officials, they learned that patients are not really being injected with total nucleated cells harvested from amniotic fluid. Despite what the clinic present in its literature and live seminars held in their office, the only live total nucleated cells in their treatments are cells provided by the patients themselves.
Such a clarification was necessary for the Fox 5 story. But it’s also necessary in the clinic’s literature and live presentation. In fact, the confusion should never be created to begin with. Why even imply using live total nucleated cells from amniotic fluid when they do not exist?
It turns out that the clarification is also necessary from a legal standpoint. Current FDA regulations allow clinics to utilize minimally manipulated autologous total nucleated cells without any further approval. But if the clinic’s amniotic fluid did indeed contain live total nucleated cells, it would be beyond the scope of current regulations. The clinic would have to seek approval for any procedures involving said amniotic products.
The fact that they have not sought FDA approval means they are either in a state of non-compliance or their amniotic products do not contain live total nucleated cells.
We Can Do a Better Job
There should be no doubt that Apex Biologix supports the concept and business of regenerative medicine. After all, we make our living selling PRP kits, total nucleated cell kits, centrifuges, etc. Yet we recognize our industry needs to do a better job of avoiding confusion.
We can do a better job if all interested parties make a commitment to avoid sensationalism and deal only in facts. Are you willing to join us in this endeavor?