As Epstein explained, the case (then pending before the U.S. Court of Appeals for the D.C. Circuit) concerns a stem-cell procedure developed by Colorado doctors Christopher Centeno and John Schultz. The doctors’ procedure involves the patient-specific extraction of blood and bone marrow stem cells, centrifuged, grown, and sterilized in their in-house laboratory, and then reinjected into the patient’s own body. The FDA claims that the doctors’ procedure involves the manufacturing of “drugs” for sale in “interstate commerce” that falls within its statutory purview to prevent the spread of “communicable diseases.”
In August 2012 we provided a free download of Dr. Centeno's own book about the case, "Why the Stem Cell Debate Will Determine the Future of Medicine," in which he details the origins and history of the raging debate between the FDA, which insists autologous stem cells are in fact prescription drugs and must be regulated as such, and innovative researchers and practitioners, who believe that removing a person's own cells, culturing them to make them more effective, and returning them to the patient's body should be considered a medical procedure—not a drug.
Now we must unfortunately report that the Court of Appeals did not rule as many might have hoped. Below is the full text of a message sent to friends and supporters by Dr. Centeno on February 13, 2014. We will, of course, continue to keep you informed of any future developments in this case.
You may or may not have seen that on Monday the DC Federal Circuit decided in favor of FDA in our landmark lawsuit challenging that our patient’s own cells could be classified as drugs. While we may ask for clarification of a few points, we won’t appeal to the Supreme Court at this point. This long battle has taken 5 1/2 years. On the plus side, since we haven't cultured stem cells for clinical use in our Colorado practice since 2010, not much changes for us.
As many of you know, while we were challenging the regulations that made cultured stem cells drugs, we never stopped treating patients and innovating with the same day stem cell procedures that the US allows. We will continue to perform these procedures in Colorado and continue our research so that our cultured technology can continue to be licensed into countries that permit it as the practice of medicine. For example, we just published on-line the results of our now 1,500 patients and counting who were treated with the allowed stem cell procedures and we’re seeing remarkable results in many body areas. We will submit two more scientific publications this month, one a case series of patients with full thickness ACL tears healed through same day stem cell injection and the other an n=1104 treatment registry report of knee and hip OA patients treated without culture. We also have four Randomized Controlled Trials that we’re funding and that are recruiting now. Our practice remains healthy and our ability to discover new therapies for our patients has never been stronger. As many of you know, our team and others is involved in birthing a new medical specialty, one that will see many existing surgical treatments for orthopedic problems morph to the non-surgical.
In summary, this battle has certainly taught me that fighting city hall is tough—the deck is definitely stacked very heavily in their favor. Having said that, my family, friends, and others have been great throughout. I’d like to throw out special thanks to the Manhattan Institute, AAOM, and AMMG who threw their hat in the ring. In addition, I’d like to thank the group Patients for Stem Cells as they have been a tireless supporter of my efforts.
Chris Centeno, M.D.
Return to February 2014 e-Journal