Stem Cell Therapy and the FDA
Why isn’t stem cell therapy more widely advertised?
FDA mandates limit us. We are unable to make any sort of medical claim about expectations for success. This includes advertising or posting written patient testimonials.
Is the stem cell isolation procedure FDA approved?
Yes, our protocols follow same day tissue transfer guidelines and “minimal manipulation” guidelines as set forth by the FDA. Your stem cells are harvested and re-administered to you on the same day within a closed system. We utilize a sterile technique for harvesting autologous stem cells. We process (extract) your cells all in the same facility to prevent contact with any outside contaminants. Our isolation procedures fall under the category of physician’s practice of medicine wherein the physician and patient are free to consider their chosen course of treatment. This is provided as a service and as a practice of medicine only. This procedure is not a drug nor do we claim it to be a cure for any condition.
FDA regulation and Politics of Stem Cell Therapy:
The FDA is set up to mandate devices and drugs only. The FDA needs to be able to understand this regenerative medicine field so it can approve and regulate this therapy. Right now it is NOT designed to. We hope this changes and will be able to regulate all centers like ourselves in the near future!
Politics have no place in potential therapeutics like Stem Cell Therapy and have swayed the general public as well as some of the medical community alike. It is a huge shame in our opinion, as Stem cell therapy has helped many of our own patients as well as numerous others the world over. This is an exciting field to be a part of and we hope you choose us here at Dynamic Stem Cell Therapy in your regenerative needs.
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