FDA regulators made no bones about it in 2017 when they announced their intention to go after the fledgling regenerative medicine industry. After multiple news reports detailing stem cell procedures gone awry, the federal government’s healthcare regulatory agency decided enough was enough. In the 14 months since, they have been working on a framework for better regulation.
Organizations like the Advanced Regenerative Medicine Institute (ARMI) find themselves in a delicate position. They want to be able to continue offering doctors regenerative medicine training within the boundaries of current regulation. At the same time, they do not want to give doctors the impression that stem cell and platelet-rich plasma (PRP) therapies are a cure-all.
At issue are not the procedures taught by the ARMI and used by doctors around the country to treat orthopedic injury and disease. Rather, the FDA is going after risky and questionable procedures like stem cell therapy for macular degeneration.
In light of that, the FDA has four areas of concern:
1. Physician and Clinic Claims
The medical industry must be very careful about claims made regarding procedures, drugs, or therapeutic treatments. They are not allowed to proclaim that something works if it doesn’t. They are not allowed to exaggerate the efficacy of an already approved treatment. In other words, regulations require healthcare practitioners and providers to be upfront and honest.
Unfortunately, a small percentage of doctors offering regenerative medicine therapies are crossing boundaries when it comes to making claims. They claim stem cell and PRP injections can do things they are not proven to do. In some cases, they are even endangering their patients.
2. Clinical Studies
Current FDA regulations already allow doctors to utilize both stem cells and PRP for autologous procedures provided that the harvested material is manipulated only minimally before being injected into the patient. Furthermore, procedures must be homologous. In other words, the stem cell or PRP material being injected must perform the same basic function for treatment as it does naturally.
For this reason, stem cell injections to treat osteoarthritis do not need further FDA approval. Now the FDA wants to make sure that any procedures that exceed the boundaries of minimal manipulation and homologous use are subject to proper clinical studies to ensure both safety and efficacy.
3. Material Sourcing and Processing
Next, the FDA is very concerned about material sourcing processing. Sourcing stem cell and PRP material is not a problem for doctors performing autologous procedures. In an autologous procedure, the patient donates his or her own stem cells or blood.
As for processing, the FDA is concerned with what actually qualifies as minimal manipulation. Some clinics are pushing the manipulation envelope, causing the FDA to rethink its current definition. This could eventually be the biggest game-changer in autologous stem cell procedures.
4. Training and Qualifications
Finally, the FDA does not require doctors to train with an organization like the ARMI before offering autologous stem cell and PRP therapies. Thankfully, smart doctors do undergo training. Yet there are those who just decide to begin offering regenerative medicine treatments based only on their own skills as physicians. For right or wrong, the FDA doesn’t think that’s a wise idea.
There would be no need for agencies like the FDA in a perfect world. But this world is by no means perfect, as demonstrated by some of the stories we’ve heard about botched regenerative medicine procedures. So the FDA will do what it must do to protect patients. Hopefully they will find that perfect balance between patient safety and the need for minimally regulated medical innovation.