The New York Times recently published a story about a lawsuit brought against an orthopedic prosthetic company for distributing their product without appropriate FDA approval. The story calls into question not only the process by which new technology is brought into practice, but the choices the clinician must make when deciding the best options to use on a patient. We need to study every new technology with evidence based means and make critical decisions on the outcomes resulting from those studies. We clinicians strive to always do better.
As I am sure you realize, the FDA and other parties are anxious to have more data, especially when it comes to the newer technologies in Regenerative Medicine. To the best of my knowledge and based on my ongoing scrutiny of the scientific and orthopedic medical literature, Regenexx is the only scientific laboratory to date that has repeatedly met with the FDA and their agents and been allowed to offer regenerative technology under the highest level of scrutiny. My particular targets are arthritis and synovitis. My therapeutic approach to pain, altered function, reduced motion, delaying and even avoiding a joint replacement, and reversing the natural progression of arthritis is mostly based on the research and publications of Regenexx; and in addition more recently, on the outcomes from the continuing monitoring of our own Regenexx Chicago data base.
When it comes to patient care, I explain risks and benefits in generic terms citing percentages from my understanding of the information presented at scientific meetings, that which I read in the medical literature, the publications from Regenexx, and information gleaned from my own investigations. The Decision-Making process should be and at Regenexx is based on registries. The governments of countries outside the United States have required participation in registries for many years; there is no such requirement in the United States. Regenexx for the past seven years has maintained such a registry, and when I joined the Network three years ago, added to the comprehensive nature of those outcome measurements.
Innovation is important to advance patient care. Regenerative Medicine is truly a transformational innovation. We want patients to respect our ability to make decisions about what is in their best interests. This foundation of respect will only result from unbiased decisions and will be strengthened when more recent entries into the field of stem cell care present scientific data and not “this is how I do it” or criticism based on market place competition. Regenexx has introduced a stable and stem cell methodology with a proven track record. This being the case, others should be careful when choosing to forgo that approach. In a spin on the words of the immortal Jerry Maguire, Show Me Your Data.
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, technology, treatment