From on high comes the following declaration …

“You Don’t Own Your Stem Cells—They’re Drugs”

I n a despicable demonstration of imperial power, a Federal agency has declared that your own stem cells are drugs, and that stem cell therapy is interstate commerce because it affects the bottom line of drugs that have been approved in other states! Therefore, stem cells should be regulated by the same Federal Agency “responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable.” That’s a laugh. Just in case you didn’t identify whose mission statement is quoted, it’s the FDA’s. Ha!

We all possess adult stem cells, which appear after early development. These are undifferentiated cells, having the ability to become any particular type of cell found throughout our bodies. That’s their purpose. When the need arises, they multiply by cell division to replenish dying cells and regenerate damaged tissues. Adult stem cells are heroic. Yet as they age, they don’t work as well.

In 2010, Centeno-Schultz Medical Clinic in Broomfield, Colorado—a clinic which isolates, cultures and processes adult stem cells from a patient’s bone marrow or synovial fluid—filed a complaint for declaratory and injunctive relief barring the FDA from regulating its use of adult stem cells, marketed for the treatment of musculoskeletal and spinal injuries. The FDA responded by suing for a summary judgment against Centeno-Schultz. It’s still going on.

In Centeno-Schultz’s non-surgical treatments, its doctors remove stem cells, the most potent of which are cultured and then returned to their owner’s bodies to treat fractures, torn tendons, and other ailments. The clinic charges its patients $7,000–9,000, carries out about 20 procedures each month, and says it will fight the FDA’s attempted injunction. Unlike conventional bone-marrow transplants of blood-forming stem cells, the Centeno-Schultz’ procedure relies on mesenchymal stem cells, those that can potentially transform into bone, cartilage, or fat. Having treated hundreds of patients in the last few years, 60% report a greater than 50% reduction in pain, and fully 40% report more than a 75% reduction. And unlike umbilical stem cells, there have been no reports of cancer-like complications.

Nevertheless, the FDA argues that Centeno-Schultz’ (the defendants’) “practice of medicine” defense is without merit; that FDA jurisdiction over defendants’ conduct does not violate the commerce clause; that the defendants’ procedural challenges do not preclude summary judgment; that the defendants’ cultured cell product is more than minimally manipulated; and that the adulteration and misbranding charges are beyond dispute. Thus, the defendants’ violative conduct should be prohibited. But if we follow the money implications, the FDA blatantly says in court documents that the agency wants to protect the market for FDA-approved drugs!

While hard to believe, this new Federal power grab would derail what promises to be a great leap forward for abating pain and promoting significant rehabilitation, and undoubtedly a great deal more. For example, Centeno-Schultz’s knee procedure took a 68 year old triathlete from needing a knee replacement to completing the 2008 Hawaii Ironman Triathlon. Jarvis Green, a two-time super bowl football champion failed surgery therapy for his knee pain. Facing the end of an eight-year career, Jarvis turned down additional surgery, and elected to undergo the Centeno-Schultz procedure which enabled him to use his own mesenchymal stem cells. Shortly after receiving his stem cell treatment, Green was back in the NFL. “Before, I couldn’t walk up the stairs,” he said in an interview. “Three weeks later, I went to an NFL training camp and didn't miss a day.”

In case you didn’t know, beyond these triumphant outcomes, the field of regenerative medicine (as it is called) empowers scientists to grow tissues and organs in the laboratory and safely implant them when the body cannot heal itself. It is a brave new world that we are moving toward, and the FDA wants to stop it.

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