By an Evidence-Based Cellular Orthopedic Surgeon
Memorial Day has come and gone. On May 31, the FDA finally started enforcing many of its rules; and Amniotic Fluid, for the time being, is no longer considered FDA compliant. Gone too are all the other biologic purveyors who did not follow the rules or they are now hustling products without FDA approval, beware. What remains compliant is the use of your stem cells contained in your bone marrow along with the platelets, precursor cells, and platelets housed or produced in your bone marrow. The other generally acceptable category of orthobiologics falls under the classification of Platelet Rich Plasma. The clarification of this latter offering is beyond the scope of this blog since platelets are responsible for a huge network of anti-inflammatory proteins. Should you choose to consult with me, I will be happy to expand on the category of Platelet Rich Plasma.
One orthobiologic category that has not fully been clarified by the FDA to the best of my knowledge is that of Wharton’s Jelly. I am researching and investigating. On the other hand, the FDA rules still apply to the majority of biologics:
1) The cells used must come from you, i.e., autologous.
2) Any cells used may only be minimally manipulated without the addition of outside agents.
3) Any cells used may not be culture expanded.
There are exceptions to the rules and those exceptions are FDA compliant when used in conjunction with an FDA-approved Clinical Trial such as the one for which I was a co-investigator with the first of its kind Personalized Stem Cells Clinical Trial for osteoarthritis of the knee. In the next several weeks, I am anticipating the opportunity to review the Phase 2 Stromal Vascular Fraction protocol to be submitted to the FDA for the next FDA Trial.
I started the first paragraph of this Blog alluding to Memorial Day. Prior to and since May 31, I personally have been cycling, fly fishing, gardening, etc. despite arthritic hips and knees. My lower back is not so great either. What keeps me going and enables me to enjoy an active recreational profile are the biologic injections I periodically receive; the very cells, PRP, and Growth factors that I write about in my Blog. There is so much to explain about my non-operative schedule of care for an arthritic joint with a needle and not a knife that I encourage you to visit my Blog at www.sheinkopmd.com. Better yet, call my office and schedule a consultation (312) 475-1893.