Platelet-rich plasma (PRP) therapy is a form of regenerative medicine that is currently being used to treat musculoskeletal injuries, degenerative joint disease, hair loss, and more. It is a safe and effective therapy when used in accordance with current FDA regulations governing minimally manipulated autologous material. Unfortunately, widespread adoption of PRP therapy has been fleeting.
An excellent March 13 (2019) piece from Forbes contributor Peter Ubel addresses the slow adoption of PRP therapy head-on by encouraging patients to be better guinea pigs. We assume he uses the phrase ‘guinea pig’ tongue-in-cheek, given that he has undergone the procedure to treat his osteoarthritis.
In short, Ubel makes the point that patients can help encourage more widespread adoption of PRP therapy by insisting that their doctors track results and accumulate data that can be presented in a meaningful way. He makes a great point indeed.
PRP Therapy and Osteoarthritis
Osteoarthritis is a degenerative joint disease that affects millions of people around the world. It is most often related to age, but other things can lead to its onset. What makes osteoarthritis so maddening is that there really is no cure. The best doctors have been able to do prior to the introduction of PRP injections is either treat symptoms or completely replace affected joints.
PRP therapy is different because it does neither. Rather than treating symptoms, it gets to the root cause of the disease itself. It also promotes natural healing that reduces the need for long-term pain medication, steroid injections and, ultimately, joint replacement surgery.
In Ubel’s case, he has long been skeptical of both PRP injections and something known as prolotherapy. His skepticism is a direct result of the lack of clinical evidence proving the efficacy of either treatment. Thus he encourages patients to insist that their doctors start building that body of evidence.
PRP Therapy and FDA Approval
You might be wondering why a procedure as basic and rudimentary as PRP therapy doesn’t have more clinical data behind it. Well, it all boils down to FDA approval. Researchers have been unwilling to put the tens of millions of dollars into the process of gaining FDA approval because such approval is not necessary. And because they are not trying to win approval, they are also not producing large-scale clinical studies that also prove efficacy.
Apex Biologix, a company that supplies doctors with PRP kits and other regenerative medicine supplies, says that FDA approval is not required for a PRP osteoarthritis treatment because such treatments already fall under the purview of current regulations.
Those regulations allow doctors to extract blood from patients, process it in a centrifuge to isolate platelets, and then inject those platelets back into the patient as long as the resulting material is minimally manipulated. Blood spun in a centrifuge qualifies as such.
Efficacy and Anecdotal Evidence
Knowing that the FDA does not require approval for autologous procedures utilizing minimally manipulated material, we are back to the problem of a lack of clinical data. Ubel’s solution to that problem is one of building a database of anecdotal evidence. This is where patients and doctors can work together.
Patients can press their doctors to provide evidence of efficacy from past cases. If enough of them press, doctors may begin more accurately tracking their patients. They might begin collecting and organizing data that could eventually be used in place of standard clinical trials to demonstrate efficacy.
Would Ubel’s idea work? Perhaps, if enough patients and doctors got involved. In the absence of such an effort, patients like Ubel will remain skeptical for lack of clinical evidence.
