Let me make it clear, I am not opposed to FDA oversight and regulation of Regenerative Medicine. Just the opposite, I would like to see more enforcement. The evidence based medicine that I adhere to is the result of my education, residency and fellowship training, outcomes research, 40 year surgical experience and continuing clinical practice, I am Board Certified in Orthopedic Surgery and a Fellow of the American College of Surgeons. I follow the FDA and other governmental guidelines in my Cellular Orthopedic endeavors and will be guided by the conclusions reached later this month when the courts update the statutes pertaining to the practice of Regenerative Medicine. My clinical work is directed to the Care of the Aging Athlete although I am very interested in helping an arthritic patient avoid or postpone a joint replacement as well as intervene as indicated to keep a developmental condition from progressing to arthritis.
What prompted this autobiographic outburst is the result of my interaction with several potential patients who believe that homeopathy is a reasonable alternative to evidence based medicine. They believe that choice of care may be based around an ad on Google. So as to better understand a younger generation, I did some Internet investigation. From Wikipedia, “ Homeopathic remedies are found to be no more than a placebo, and homeopathy is widely considered a pseudoscience”. Then there is the entire field of Prolotherapy; in this form of treatment, sugar solution is injected into an arthritic joint. No one understands the mechanism of action and “a lack of biologic evidence has kept prolotherapy from gaining mainstream medical acceptance” according to WebMD.
Our goal in a stem cell intervention for the symptoms, limited motion, and altered functional capacity caused by osteoarthritis of any joint is not only short-term relief of symptoms but a cessation of the progression of arthritis and a possible regeneration of that joint. Does it work as desired in every case? Absolutely not but the outcomes evidence is mounting that it meets our goals in the majority of patients. Is a positive outcome necessarily permanent? No necessarily but just as a total joint may need to be revised, so too may a stem cell intervention be repeated.
The discipline of Cellular Orthopedics is evolving and so too is our technology. We have adopted an improved technology with more chondrogenic potential based on laboratory observations. Wherein a patient has not enjoyed the end point desired, we offer booster interventions. I will bring you news of the FDA decision-making process regarding next generations of mesenchymal stem cell processing as the courts make those decisions public. Regenexx stands at the forefront of the stem cell revolution in orthopedic care. Before you base your arthritic care decision making on Google ads, make sure you understand who, what, why and how; not just where and how much.