There is an effort afoot in Colorado to convince the state legislature to pass some new laws intended to protect consumers from being scammed by PRP and stem cell clinics. A similar effort was undertaken in Florida in 2018 to no avail. Both efforts invite an important question: is stem cell legislation needed to protect patients?

According to Denver’s ABC affiliate, local doctor and regenerative medicine researcher Chris Centeno is leading the charge for legislation that would “protect Coloradans from wasting thousands of dollars, per injection, on unregulated and unproven stem cell therapies.”

Centeno makes a compelling case by citing for-profit stem cell clinics that claim to use amniotic donor tissues. In other words, the stem cells they are injecting into patients are harvested from amniotic tissues obtained from hospitals. The stem cells do not, and cannot, work, according to Centeno.

Working within FDA Regulations

Current FDA regulations require unapproved PRP and stem cell procedures to be limited to minimally manipulated, autologous material. It is completely legal and safe for a doctor to extract stem cells from a patient’s fat tissue, process those cells, and then inject them back into the same patient. The problem with amniotic tissues is that they are not autologous.

Centeno says that the advertised amniotic products consist of dead stem cells rather than live ones. As such, they cannot possibly help. This is what he is concerned about. Centeno is by no means concerned about PRP and stem cell therapies that fall within the scope of FDA regulations. In fact, he often suggests PRP therapy to his patients.

Apex Biologix, a Utah company that supplies doctors with centrifuges, stem cell kits, and other regenerative medicine supplies, explains that Centeno is not alone. They work with doctors and clinics across the country who utilize autologous PRP and stem cells to treat a variety of issues while working within the current FDA regulations.

The Legislation Question

Given what we know about PRP and stem cell therapies, the question of legislation is a tricky one that has to be addressed on multiple levels. First and foremost is the idea of preventing patients from spending thousands of dollars on injections that may not work.

You could make the case that patients have the right to spend their money any way they want. As long as treatments are safe, should government really be involved in the question of efficacy? Any legislation intended to prevent patients from being scammed would probably be best if implemented as ‘truth in advertising’ regulation. Otherwise, legislators begin treading on the dangerous ground of telling people how they can and cannot spend their money.

Another concern is just how far any potential regulations would go. Would they focus only on clinics selling amniotic tissue products, or would they also affect clinics like Centeno’s? His clinic and so many others are successfully treating patients using autologous PRP and stem cell material.

Less Is More

There is little doubt that some unscrupulous doctors and clinics are making false promises to patients. It’s true that some of them are selling amniotic tissue products that do not do what doctors claim. It’s even true that legislation could help patients to some degree. The tricky part is figuring out how much legislation is necessary and how far that legislation should go.

As a general rule, less is more in terms of medical regulation. History has proven that the more onerous regulations are, the less incentive there is to develop new treatments, protocols, and medical devices. Where freedom reigns, so does innovation. Do you see the problem?