4 Facts About Stem Cell Regulations
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 under the proper conditions these treatments are legal. But they are highly regulated and there are other nuanced questions and misunderstandings within this topic. We’re here to break it down for you and tell you about 4 facts regarding stem cell regulations.
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 cells – those cells that are harvested from your own body and applied on the same-day as the harvest – do not fall in either of the “drug” or “medical device” categories. This is why we cannot say that these treatments are FDA-approved. The FDA can only approve of “stem cell-based products”, which today are called human cellular or tissue based products (HCT/Ps). That brings us to our next point…
There is a Difference Between Autologous Stem Cells and “Stem Cell-Based Products”
As we mentioned, the FDA allows, but does not approve of autologous stem cells used in same-day procedures. In order for this to be true the harvested cells can only undergo minimal manipulation and must be delivered back to the patient within hours. However, the FDA does regulate HCT/Ps. What does this mean? These products 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. At Piedmont Physical Medicine & Rehabilitation, we use both autologous structural support cells and HCT/Ps. Autologous tissue is typically derived at Piedmont Physical Medicine & Rehabilitation from the patient’s adipose tissue. If we apply a Manufacturer derived HCT/Ps then it comes from an FDA-approved supplier. Under strict regulation, they obtain permission to label their products accordingly. All of our procedures regarding regenerative medicine follow the guidelines published by the FDA. Our choice of treatments, whether it include the use of structural support cells or HCT/Ps, 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 tissue. 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.
We have helped hundreds of patients find relief with regenerative medicine treatments. We make every effort to ensure that all of our patients are in safe, ethical and qualified hands. Many times, when people come in asking for “stem cell” treatments, it is also not uncommon for us to redirect them to something else less expensive and more traditional to do the job. We do our best to only provide those treatments for patients that need it.
Come to Piedmont Physical Medicine & Rehabilitation and we will be glad to walk through all the steps with you. It’s our goal to ensure that our patients are comfortable and knowledgeable about any of our procedures before we perform any service.
Ready to take the next step? Call for a consultation to see how we can help at 1-864-235-1834.