Physicians who undergo PRP and stem cell training at the Advanced Regenerative Medicine Institute (ARMI) complete their training with a thorough understanding that there are right and wrong ways to apply what has been learned. While in training, they learn how to utilize PRP and stem cell therapies while remaining within FDA regulations and maintaining patient safety.
Unfortunately, not every physician offering regenerative medicine has been properly trained. Some of them are responsible for operating clinics clearly outside the boundaries. What can be done about it? For one thing, physicians can start policing themselves a bit better. A step in that direction was recently taken by the American Academy of Stem Cell Physicians (AASCP).
According to a recently published press release, the AASCP has established safety guidelines for all physicians who offer regenerative medicine procedures. The guidelines cover procedures that utilize bone marrow, amniotic products, peptides, and other biologics. They also cover autologous PRP and stem cell procedures.
FDA Regulations Already Exist
Safety guidelines developed by the AASCP are by no means enforceable. In other words, they are not regulations. But that does not mean the stem cell industry is unregulated. In fact, just the opposite is true. Despite what the media claims, stem cell therapies are currently regulated under existing FDA rules. The problem is that some clinics and suppliers have decided to operate outside of those rules.
The key to practicing safely and legally is what the FDA calls ‘minimally manipulated’ biologic material. Minimally manipulated material is material that is not significantly altered from its natural biological state through chemical or other means. It is also material that does not contain additional materials that would constitute a new drug when combined.
Platelet-rich plasma (PRP) is an excellent example of minimally manipulated material. A typical PRP procedure for treating osteoarthritis begins with a blood draw. Blood is taken from the very patient being treated. That blood is spun in a centrifuge to isolate platelets and their growth factors. The resulting material, altered in no other way, is then injected into the affected joint.
This sort of procedure is completely legal under FDA regulations. It is also completely safe, given that patients are providing their own blood for the procedure. There is no risk of rejection and only the same minimal risk of infection common to all procedures involving needles.
Making Regenerative Medicine Safer
Knowing what we know about FDA regulations, one might wonder why the AASCP decided there was a need for safety standards. The reason is simple: doctors offering regenerative medicine do not necessarily know everything about the partners they work with.
The new safety standards are intended to encourage clinicians to be more diligent about working with their partners to maintain safety. For example, a doctor ordering peptides from a new supplier is encouraged by the standards to thoroughly vet that supplier. The doctor should seek to learn from where the peptides are sourced, how they are produced, etc.
The safety standards are essentially an effort at self-policing. It is a good step in the right direction. Regenerative medicine holds a lot of potential for treating all sorts of injuries and diseases. Yet it is unnecessarily being given a black eye every time a rogue clinic or doctor does something deemed unsafe.
By establishing the standards, the AASCP and its member physicians are taking a stand. They are saying that standards need to be applied and adhered to. Hopefully, the vast majority of clinicians whose practices now include stem cell and other regenerative medicine therapies will put the standards into action.