A week from today, if the government is still running, we will be squaring off with the FDA on whether cultured stem cells produced by a physician in his or her office for one unique patient are a drug or the practice of medicine. If you want a detailed account of this effort, I‘ve actually written a short book on the topic. In summary, while the agency has taken no issues with our same day procedures, they have objected to the advanced Regenexx-C procedure, claiming that if we culture your cells over several weeks to get more, then we create a prescription drug out of you. We respectfully think they’re nuts, so we challenged the policy. This has led us to the DC Circuit, where on 10/21 at 9-9:30 am EST I will tweet the blow by blow. It should be an interesting event. My Twitter handle is @CCentenoMD.
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Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile
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