As many of you know, the FDA has declared that when a doctor cultures your cells to get more, the doctor somehow turns them into a prescription drug. This is despite the fact that other medical cell culture procedures like In-vitro Fertilization (IVF) don’t create such a drug, according to the FDA. While this hasn’t impacted Regenexx-SD and the other same day procedures we perform using stem cells or platelets, it has impacted Regenexx-C. As a result, we will be licensing the Regenexx-C Procedure to an independent vendor to be performed only outside the United States. Importantly however, we’ve also challenged the FDA in a landmark case that will define once and for all if the stem cells, genes, or anything else in your body is a “body part” or a prescription drug. Writer Jayme Moye just wrote an excellent piece for our local 5280 magazine “Top Docs” issue which looks at the landmark nature of our FDA struggle entitled, “Power Play: A Front Range M.D. has developed a potentially revolutionary treatment for orthopedic injuries. So why is the FDA trying to stop him?”
~ Dr. Chris Centeno
