There are several reasons behind the subject matter of this Blog. First, recent scientific studies have indicated that 2% of patients who have a joint replacement will have undergone a corrective revision within the first three years. Two percent isn’t a large number until it affects you. Approximately 20% of knee replacement recipients have significant pain and another 30 % fail to regain the desired motion confirming an earlier Canadian study in addition to those who fail outright at three years or less. Lastly, clinical studies at Regenexx have documented an average 15-point pain score improvement following a second stem cell intervention. Assume if you will that 100 points indicate a patient is pain free and prior to the Bone Marrow Aspirate Concentrate procedure, that patient had a score of 60. The average improvement after a stem cell procedure is to about 80 points. If you assume an additional 15 points will be gained by the second stem cell intervention, you will understand why I am writing this Blog.
We in the Regenerative Medicine world have been waiting a ruling by the DC Circuit Court regarding stem cell expansion and manipulation. The FDA allows Stem Cell intervention as long as those cells are not cultured or manipulated with external adjuncts. That is why we follow the Same Day Procedure in its present format. The Regenexx algorithm is FDA compliant. On February 5th, The DC Circuit sided with the FDA regarding stem cell culturing and manipulation with external agents. If you go stem cell “surfing” on the web, watch out for those sites marketing stem cell expansion and use of Adipose Derived Stem cells (SVF). I expect the FDA to go after several new SVF clinic networks within the year.
Meanwhile let’s return to the issue of a second stem cell intervention. If we can’t culture, we certainly may repeat. The Regenexx Data clearly support an average 15-point increase in a patient’s pain score when that second intervention is completed within a year of the index procedure. As many of my patients have experienced, to date, I have offered a booster PRP injection within three to six months when that patient wants more from the Same Day Stem cell undertaking. My approach has been helpful; although as of this time, I don’t know to what degree and for how long? For those contemplating a Bone Marrow Aspirate Concentrate minimally invasive treatment of an arthritic joint, be aware that there is now a way to predictably improve the ultimate outcome at 18 months with a second Stem Cell procedure.
Tags: arthritis, athletes, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, FDA, Mature Athlete, Microfracture surgery, Platelet Rich Plasma, Regenerative Pain Center, Regenexx, stem cells