When is a Bone Marrow Concentrate Intervention a Failure?
Last week, a patient who had enrolled in the initial Regenexx Stem Cell Clinical Trial for an arthritic knee visited the office for his five year follow up. He had never paid a nickel out of pocket other than obligatory office co-pays for the intervention. Five years after the administration of concentrated bone marrow, he shared his dissatisfaction with the five-year outcome indicating he had scheduled a total knee replacement because of the ” failure”. The same week, four years after another patient had undergone a bone marrow concentrate intervention for his arthritic hip on a fee for service basis, the patient thanked me for having assisted his return to an active lifestyle. With the return of some symptoms, he asked that I repeat the procedure and help him delay a total hip replacement for another four years, perhaps longer.
What is the benchmark of success when it comes to a cellular orthopedic intervention? On the one hand, five-year postponement and electing to undergo a joint replacement or four years of enabling an active lifestyle and then repeating the intervention. From the humanistic side, the unhappy patient always had a demand and a complaint when seen over the five years while the positive patient always had a smile and a thank you.
Over the several years since beginning my Interventional Orthopedic Practice, I have significantly improved the techniques and technology. In addition, over the last month, I have added the technology enabling customization of the injectate with the addition of the Hemoanalyzer to our algorithm. As in any outcomes analysis, there is the subjective component and the objective component. The ultimate determinant as I see it is the activity profile and scoring.
My Interventional Orthopedic practice is focused on protecting my patients from unproven treatments that may be harmful and unethical, financially exploiting the public; First No Harm. Witness the seductive newspaper ads placed by non-MDs offering stem cells for regeneration using amniotic fluid. I am compliant with federal regulations and the Principal Investigator in a national Amniotic Fluid Clinical Trial. From a scientific perspective, while amniotic fluid may be beneficial for six to 18 months, the proper dosage has yet to be determined and there are insignificant living stem cells in that which is being offered. Also, note that tissue-based stem cell products may not be administered in the absence of an FDA approved indications or approved research protocol.
My Regenerative Medicine, Interventional Orthopedic practice is evidence based and everything that I do is under IRB protocols; that is FDA oversite.
To learn more, you may schedule a consultation by calling 312 475 1896
View my website www.sheinkopmd.com
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Disclaimer: Like all medical procedures, Regenexx Procedures have a success & failure rate. Not all patients will experience the same results.