The Food and Drug Administration (FDA), citing regulation of a "cultured cell product," is seeking an injunction against Broomfield-based Regenerative Sciences, LLC for its use of stem cells to treat patients' pain, a procedure they have trademarked as Regenexx.
Medical director Christopher Centeno, MD denies the FDA's claims and welcomes the court fight with the FDA so he can prove the clinic "[is] not a drug manufacturer, but simply a medical practice."
The issue is whether cultured stem cells, taken from a patient and grown in the lab, can then be injected into the same patient in order to alleviate pain. The FDA says the practice is illegal: the cultured cell product, they argue, should be tested and labeled as a drug, and since the FDA has not conducted studies regarding efficacy or risks, the drug product can not be used.
John Schultz, M.D., a fellow founder of the Centeno-Schultz Clinic, claims the analogy is flawed and the cultured cells are not manufactured drugs: "What we're doing in our Colorado medical practice is no different, in principle, than a fertility clinic that uses the in-vitro fertilization technique. The only difference is that we're using stem cells and fertility clinics use fertilized eggs."
Drs. Centeno and Schultz are innovators in the stem-cell research field; recently, they co-authored a study which appeared in Current Stem Cell Research & Therapy. For its part, the FDA notes it does not want to discourage innovation, but that it must keep the public's safety in mind.
Until the litigation has been resolved, Regenerative Sciences has agreed to halt use of stem cells in treating pain.