Regenerative medicine and stem cell treatments may be fairly well-known amongst the general public, but how much do you know about the regulations of stem cell treatments? Well, for starters, let us quickly clear the air and say that stem cell treatments are legal. But there are other nuanced questions and misunderstandings within this topic. We’re here to break it down for you.
The FDA Only Approves/Denies the use of Drugs and Medical Devices
One of the first questions many people ask is: are stem cell treatments “FDA-approved”? First, we want to clarify that the FDA only approves and denies the use of drugs and medical devices. Autologous stem cells – which are done in same-day procedures – do not fall in either of the “drug” or “medical device” categories. This is why we cannot say that stem cell treatments are FDA-approved. The FDA can only approve of “stem cell-based products.”
There is a Difference Between Autologous Stem Cells and “Stem Cell-Based Products”
As we mentioned, the FDA cannot approve of autologous stem cells used in same-day procedures. This is because these stem cells undergo minimal manipulation and delivered back to the patient within hours. However, the FDA does regulate “stem cell-based products.” What does this mean? These cells are also not autologous, meaning that they may come from a variety of different donated sources. They may also be cultured or processed by a lab for commercial use before distribution.
The FDA Does Not Regulate the Practice of Medicine
The practice of medicine refers to a physician’s and patient’s ability to freely to consider their chosen course of treatment. All of our procedures regarding regenerative medicine follow the guidelines for cellular therapy published by the FDA. Our choice of treatments, whether it include the use of stem cells or otherwise, are dependent on individual patient’s needs.
There is Overwhelming Support to Keep the FDA Out of Autologous Stem Cell Treatments
Those who are aware of the issues surrounding stem cell procedures have voiced concern about what it might mean to regulate autologous stem cells. While everyone recognizes that there is a need to ensure proper safety and handling of biologics, there is also a strong belief that there is no role for more aggressive government regulation when it comes to what patients are permitted to do with their own body. Many people just find it hard to accept that tissue from their own body needs to be treated as if it were a drug. And there are long-term precedents to support this point of view. For example, skin grafting in burn victims and egg harvesting in fertility clinics have been using autologous biologics for years.