Resolving a regenerative medicine dilemma
I rode my bike this past Saturday and Sunday through the Chicago Forest Preserve bike trails and I had some time to reflect. Just as in fly fishing, cycling is meditation time. I tried to answer questions that came to mind such as how could Abraham have fathered both Izsak and Ishmael in his late 90s? Was it the triumph of stem cells or something more? I reflected on this through the Monday service without resolution other than we are still dealing with the ramifications.am
On Tuesday morning, the usual and customary ad in the Chicago Tribune paid for by the Stem Cell Institutes of America appeared inviting readers to a seminar to learn more about their approach to pain from arthritis and assuring the reader that their techniques are FDA compliant. Their approach is based on Amniotic Fluid injection. What I do know is FDA compliance requires that the stem cells must be yours (autologous) and that amniotic fluid once processed, sterilized, frozen and fast thawed has no viable stem cells. I also am cognizant of the large body of scientific evidence supporting the notion that pain of arthritis is generated by the supporting bone as cartilage has no nerve supply. How does a single and costly injection of amniotic fluid result in long term benefit? I have to deal on a daily basis with the fallout of this marketing campaign.
Next the Wednesday, September 12, addition of the Chicago Sun Times carried an ad sponsored by The Pain Relief Institute headlining Stem Cell Recruitment. As I understand the approach, Amniofix, a placental derivative, micronized, is reconstituted and injected into the arthritic joint. Reader please note that the first bullet states “FDA Regulated”. Of interest is the fact that I refused and still refuse to use Amniofix in my practice as there are no evidence based clinical trials to support any clinical claims. Those trials are taking place now. Amniofix is a product rushed to market before there was scientific proof to support use. You may learn more about Amniofix by searching the product online. If you don’t count cells with a hemoanalyzer, how could you know what is being “recruited”?
My commitment is to stand up for my patient in this regenerative medicine chaos. I resolve to do better in the upcoming year with introspection and ongoing review of the discipline.
With best wishes for a happy and healthy 5779
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Tags: amniofix, amniotic fluid, autologous, cellular therapy, FDA, regenerative medicine, stem cell