Since the frontier days that established this great country, people have been selling snake oil to cure whatever ails you. Have things changed or is this déjà vu all over again?
If you’re not aware of the controversy I’m referring to, it’s the sudden surge of stem cell and plasma rich protein (PRP) treatments to treat sports injuries and other ailments of the body. Clinics are popping up all over the country with claims to cure a myriad of ailments – and prices to match these claims.
I recently attended the Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) in New Orleans, as I have done for the last 35 years, and this was definitely the hottest topic of the week. Many orthopedists, like myself, were eager to hear what the experts in the field had to say about this controversial topic.
The AAOS says there are over 570 clinics representing 351 businesses marketing “stem cell” treatments for orthopaedic problems. They say that most clinics use autologous “minimally manipulated” preparations that do not contain clinically significant numbers of stem cells. Widespread use of these cash-for-service, unproven, and poorly described treatments raises concerns for public health and safety.
Due to their concerns, the AAOS held a Symposium at Stanford University in February with the following objectives:
- Establish a clear, collective impact agenda for the clinical evaluation, use, and, optimization of biologics in orthopaedics
- Develop a guidance document on clinically meaningful endpoints and outcome metrics for the evaluation of biologics for common orthopaedic problems
Attendees at the Symposium agreed the following are needed:
- Clear guidelines on the conduct and reporting requirements for clinical studies involving PRP
- Disease-specific biologic targets and clinical outcomes
- Clinical registries to examine outcomes
Areas of Treatment
Stem cell and PRP preparations are being used after rotator cuff and ACL surgery, for tendinopathy in multiple areas of the body, hamstring tears, osteoarthritis of the knee and meniscus injuries. While anecdotal evidence (case studies) suggests some usefulness, especially after rotator cuff repair, there are no double-blind clinical studies yet to document the effectiveness of these treatments.
Part of the problem is the lack of uniformity of stem cell and PRP preparations from one clinic to another. The result is widespread variations in the content of the preparations given. This means comparisons are difficult and conclusions meaningless.
Compounding the difficulty is the fact that these treatments are considered experimental and therefore not covered by health insurance. Clinicians have a wide variety of expertise from orthopaedic surgeons, to family practitioners, to pain management specialists, or anyone who calls themself a “sports medicine” doctor. Patients must be aware there is no national certification for these treatments.
There may be hope for the future in this area of “biologics” treatments but at present patients should have their eyes (and their wallets) open to the unproven success. Fortunately, there has been no clinical evidence yet that such treatments are harmful; just not necessarily helpful.