Special Announcement - Now Screening for FDA Approved Stem Cell Study
Dr. Mitchell Sheinkop has completed training and is credentialed for an FDA-approved stem cell clinical trial for knee arthritis. Our clinic is now screening patients for this trial. Contact us at 312-475-1893 for details. Click here to learn more.

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.

Tags: , , , , , , , , , , , , , , , ,

Report from the OrthoBiologic Institute meeting, June 08-10, 2017

Report from the OrthoBiologic Institute meeting, June 08-10, 2017

It was difficult for me to sit and listen to so many “show and tell” presentations not supported by scientifically overseen outcomes data. Too much anecdote about unproven methodologies; many not compliant with FDA guidance. Basically, it was frequently repeated false news. I was taken aback by what so called physicians are injecting into the joints of their patients. Florida seems to lead the way in the cook book approach to arthritis followed closely by California. Illinois is guilty as well but not the medical community.  Despite my negativity about the absence of science, this gathering certainly did not begin to approach the science and integrity of presentation found in the discipline of orthopedic surgery; of particular interest to me was the universal agreement that there is no regenerative potential in Amniotic Fluid Concentrate. A matter of fact, there was not one outcomes paper presented concerning amniotic fluid. It becomes ever so important that a patient choose an experienced, scientifically oriented, regenerative medicine specialist when seeking a non-surgical option for an arthritic knee, hip, ankle or shoulder. The patient must bear in mind that the specialist’s goal is to improve function, diminish pain and postpone, possibly avoid a joint replacement for an arthritic joint. When the arthritis has reached end stage, there are those who should have a joint replacement; only a specialist is equipped to properly advise a patient.

In the orthopedic world, scientific papers are not considered to have significance unless the outcome results have been followed for a minimum of two years and more. Furthermore, the articles in order to be considered authoritative must have statistical significance.  It seems that the charlatans and camp followers are offering patients an intervention that is neither FDA compliant nor for which there is scientific outcomes data.  The one exception to all the fake news was the presentation by Dr. David Karli of Greyledge Orthobiologics who introduced The Method of Ratios for Assessing PRP and BMC Theraeutic Potential. This novel approach to quantitating and qualitating the injectate I am sure will soon become a standard of care for cellular orthopedics so I will quickly introduce into my practice. The Method of Ratios will allow the clinician to better understand what will be injected into a joint.

The appropriate method of advising an arthritic patient as to whether surgery may be postponed or even avoided begins with a specialty consultation including a comprehensive intake, a physical examination including functional testing, and review of images. Only those with specialty training, board certification and experience both in surgery and in regenerative medicine are able to properly advise the patient. I will again underscore the importance of choosing the Cellular Orthopedic expert and not determining what may be best for you by surfing the cloud.

If you want to become better informed, browse my website www.sheinkopmd.com.

You may watch my webinar at www.ilcellulartherapy.com or call to schedule a consultation (312) 475-1893.

Tags: , , , , , , , , , , , , , , , ,

Pin It on Pinterest