Regenerative Sciences Inc., a Colorado medical practice that specializes in the use of a person's own stem cells to help patients avoid more invasive orthopedic surgery, announced that the U.S. Food and Drug Administration (FDA) is seeking to enjoin the clinic physicians from practicing medicine using patients' own stem cells. The lawsuit will allow Regenerative Sciences to question the FDA's policy that adult stem cells can be classified as drugs when used as part of a medical practice.
"The FDA will finally answer our questions, in court, about their claims and jurisdiction as opposed to doing everything in their power to avoid the issue that we are not a drug manufacturer, but simply a medical practice," said Christopher Centeno, M.D., Regenerative Sciences' medical director.
The FDA claims that Regenerative Sciences is using an "adulterated" product because it fails to follow mass manufacture guidelines in its medical practice that is applied to drug factories producing millions of doses. Rather than mass producing drugs, Regenerative Sciences uses the patient's own stem cells to treat common orthopedic problems. Regenerative Sciences has had an unblemished safety record, recently publishing a large study showing that its procedure is dramatically safer than the traditional surgical procedures it has helped many patients avoid. Regenerative Science's lab has strictly adhered to the International Cellular Medicine Society's (ICMS) strict, professional guidelines and has been audited three times by independent third parties with no serious safety concerns.
"ICMS lab guidelines are the best fit for autologous cell processing and provide strong patient protection. If the FDA had any valid concerns about our medical practice not using drug factory guidelines, they knew about that in Spring of 2009 and did nothing. They did nothing because there were no safety issues. Their focus on this now is litigation posturing," stated Centeno.
Regenerative Sciences has been using its patients' stem cells to treat orthopedic conditions since 2005 and received an untitled letter from the FDA in 2008 claiming its medical procedure was creating a new biologic drug. The FDA inspected Regenerative Science's facility in 2009, and found, at that time, that it was not compliant with drug mass manufacture guidelines, but failed to take any action.
Regenerative Sciences has filed two lawsuits against the FDA in an effort to force the organization to respond to questions about their jurisdiction in the matter. The medical practice filed a suit in Denver District Court in 2008 based on the issue that the FDA regulations regarding creating a drug out of the patient's own stem cells exceeded the FDA's congressional authority and that the Food, Drug, and Cosmetic Act contains exemptions for physicians using innovative therapies that do not go through FDA approval as part of their medical practice. Last month, Regenerative Sciences was forced to file suit against the FDA again, this time seeking a Temporary Restraining Order (TRO) to prompt the FDA to take "final agency action" or leave its medical practice alone following an exhaustive inspection of Regenerative Science's facilities and taking no action.
"For two years we've been prodding the FDA to respond to our questions about how it has the ability to regulate a medical practice, so we're encouraged that, as a result of this recent suit, the courts will decide if it the FDA has regulatory authority over the adult stem cells that live in everyone's body," stated Centeno. "This is an important case for everyone that suffers from any type of illness, not just patients with orthopedic problems. It will decide, once and for all, if the government has the right to restrict a patient and their doctor from using a person's own stem cells to treat disease. Regenerative Sciences believes that stem cells are body parts and not the property of the government or big pharma."
Adult stem cells are those found throughout the patient's body. Recent medical research has indicated these important cells have as much clinical promise as the more controversial embryonic stem cells (cells taken from an embryo).
"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," stated John Schultz, M.D., one of the founders of the Centeno-Schultz Clinic.
The FDA's lawsuit is being closely monitored by the International Cellular Medicine Society (ICMS), a global nonprofit dedicated to patient safety and education in the medical use of adult stem cells that represents over 1,000 physicians, researchers and patients from over 35 countries on 6 continents. ICMS executive director, David Audley, stated "The Centeno-Schultz Clinic meets our strict criteria for the safe therapeutic use of adult autologous stem cells. There is more medical and scientific evidence supporting this type of medical therapy for orthopedic conditions, for example, than there is for many approved drugs that the FDA allows to be used in off-label or unconventional applications."
About Regenerative Sciences
Headquartered in Colorado, Regenerative Sciences, Inc. is an extension of the medical practice of the Centeno-Schultz clinic and is focused on the development of the Regenexx procedure, a non-surgical option for people suffering from various orthopedic disorders. The physicians at Regenerative Sciences have developed a patent-pending procedure that uses a person's own stem cells and blood growth factors to help regenerate bone and cartilage.
