The U.S. FDA regulation of cell therapies finally is enforced
“Mitch, not sure if you heard, but the FDA via the DOJ has requested injunctions against the mothership clinics of Berman and Lander, as well as the US Stem Cell clinic run by Comella. We can hope that criminal indictments might follow, since they certainly are some of the most flagrant violators of the law in recent med I can think of. The SCIA group can’t be too far behind. It seems that advertising all kinds of cures for everything that ails the patient makes you a higher priority target.” (Personal communication)
I am dedicated to providing patients with the best possible care in regenerative medicine and am pleased to announce that I have adopted a technology platform developed by Greyledge Technologies (Vail, CO). Their technology to generate platelet-rich plasma (PRP) and bone marrow-derived cell concentrate (BMC) is derived from successfully operating a laboratory that is registered with the FDA (listed as a “component preparation and collection facility”, FEI 3008724474), which has cleared two audits with no issues. Based on their platform, I offer my patients customized therapy, since each preparation is analyzed for platelets, red blood cells and white blood cells (among 23 parameters), which I review prior to treatment. This knowledge permits me to make adjustments based on my more than 40 years of experience in orthopedic surgical and now cellular orthopedic practice. No other system or technology gives me this kind of capability to personalize your treatment.
As a result of the technology I have adopted, my office has been able to create a scientific outcomes data base using the same parameters in cellular orthopedics as when I was the director at one of the five largest joint replacement programs in the country. At that time, I pioneered the integration of patient are with research and education. The latter allowed me to rise to the position of full professor; having publish over 75 scientific articles in the field of hip and knee joint replacement. I am happy to update you with the fact that I am at it again. On June 10, my paper concerning the preliminary outcomes of combined intraarticular and intraosseous stem cell intervention for knee arthritis will be presented in Las Vegas at of The Orthopedic and Biologic Institute (TOBI) annual meeting. The manuscript concerning Autologous Bone Marrow Concentrate and Platelet Product for Symptomatic Knee Arthritis: A Randomized Controlled Trial, Minimum 2 Year Follow-Up was submitted to a major orthopedic journal and is one of three papers I have been invited to deliver from the scientific podium of The Medrebels, October 26 to 28 meeting in Austin, Texas.
If you want to avail yourself of the best opportunity to postpone, perhaps avoid a joint replacement for arthritis while enjoying pain relief and restoration of an active life style, chose science over advertised anecdote. Call (312) 475-1893 to schedule an appointment. You may access my website and watch the webinar at www.Ilcellulartherapy.com.
Disclaimer: Like all medical procedures, Regenexx Procedures have a success & failure rate. Not all patients will experience the same results.