Use and Misuse in Regenerative Medicine
I write this Blog as an Orthopedic Surgeon following the 2018 annual meeting of the American Academy of Orthopedic Surgeons, just concluded in New Orleans. The topic matter is of sufficient concern that Use and Abuse of Biologics became an agenda focus receiving several hours of attention.
Clinical use of biologics to treat all health problems has greatly outpaced the evidence. Every office day, patients bring advertisements about Stem Cells appearing in the print media. The enticing cure all claims and testimonials are quite seductive. Concerns over misinformation from direct-to-consumer marketing of unproven treatments have led to recent calls to action from government and scientific agencies, including the National Academy of Sciences and the American Association for the Advancement of Science.
These calls to action are of special relevance to orthopedics because a recent study showed that more than 85 percent of 351 businesses, which represent 570 clinics across the country, were marketing “stem cell” treatments for musculoskeletal problems. Analyses of these treatments show a diversity of offerings with most clinics using preparations that do not contain clinically significant numbers of stem cells. Widespread use of these cash-for-service, unproven, and poorly described treatments raise concerns for public health and safety.
The Academy collaborated with the National Institutes of Arthritis, Musculoskeletal, and Skin Diseases (NIAMS) and held a think tank symposium on “Optimizing Clinical Use of Biologics in Orthopedic Surgery” on Feb. 15–17. 2018, at Stanford University to accomplish the following objectives:
- establish a clear, collective impact agenda for the clinical evaluation, use, and, optimization of biologics in orthopedics
- develop a guidance document on clinically meaningful endpoints and outcome metrics for the evaluation of biologics for common orthopedic problems
The symposium addressed key issues including poor definition of treatments and mechanisms of action; lack of standardized data and outcomes collection and reporting in existing clinical studies; and minimal evidence to support the myriad of ailments treated with these products. Leaders from clinical medicine, research, and government, as well as young investigators selected through a competitive process, participated in the event.
I am happy to be one of the first orthopedic surgeons in the Midwest limiting my practice to cellular orthopedics. Additionally, based on my model of having integrated patient care with outcomes surveillance as a joint replacement surgeon, anticipating and contributing to the new world of evidence-based regenerative medicine, I already have in place a cooperative venture allowing me to measure the platelets, growth factors and now stem cells that have been injected into a joint or the bone adjacent to that joint. I don’t know of any other practice or center that can make this claim. My team has entered into discussions to designate our model as the foundation for the future methodology of clinical evaluation, use and optimization of biologics in orthopedics.
As a patient, you have a choice to make: either respond to a marketing scheme or be educated and seek evidence before undergoing a “stem cell” procedure.
To schedule an appointment call 312 312 475 1893
Visit my web site and watch the webinar www.ilcellulartherapy.com
Disclaimer: Like all medical procedures, Regenexx Procedures have a success & failure rate. Not all patients will experience the same results.