On May 31st, the FDA made it clear, that it would crack down on the charlatans, the prostitutes, and the camp followers who both fail to follow the FDA guidelines for Regenerative Medicine offerings and put the patient at potential risk. While, I am still able to use your bone marrow in a concentrated form thereby introducing adult mesenchymal stems, platelets, exosomes, growth factors, precursor cells, and more into an arthritic joint, I am limited in using products not recovered from your body unless it is under the auspices of an FDA-approved Clinical Trial. That is what the Personalized Stem Cell Clinical Trial was all about wherein we were allowed to use Stem Cells recovered via a mini-liposuction (Stromal Vascular Fraction), and our team is preparing a second phase Clinical Trial that I hope to be able to announce in a month or so.
In addition, to the aforementioned Trial, I have upcoming meetings with two Regenerative Medicine pharmaceutical companies to plan independent clinical investigations with new products. On the one hand, the FDA did crack down after several years of warning; but at the same time, there is an opportunity to expand the scope of care if one adheres to FDA rules, regulations, and guidelines. Those of us practicing evidence-based Cellular Orthopedics, that is minimally invasive surgery with a needle and not a knife, recognize there is a population of patients who are unable to undergo a major surgical procedure for a joint or related impairment or wish to delay, perhaps avoid a joint replacement. As my several regenerative medicine publications to date confirm, it is possible to relieve symptoms and improve the function of an arthritic joint via Cellular Orthopedics. I also personally can serve as a testimonial for what is possible via evidence-based medicine having ridden my bike three out of four days (my wife was on the rides with me as were several friends) on very hilly, almost mountainous terrain, for three-hour intervals each, over the Independence Day weekend, in addition to hiking over hill and dale and through a wetland in pursuit of the Brown Trout with a fly rod on the one day I didn’t cycle. In my leisure time, my wife and I pulled weeds and tended to our vegetable garden trying to stay organic.
While I will continue to update the readers of this Blog concerning the upcoming trials, in addition to using the FDA-approved Bone Marrow Concentrate option, I also have the opportunity to use a range of Platelet Rich Plasma options that I would discuss at the time of your office consultation. To schedule that appointment, call (847) 390-7666. Learn more by visiting my web site www.sheinkopmd.com and www.personalizedstemcells.com.