A battle has been raging for quite some time without you even knowing it…
The FDA vs Adult Stem Cells
Adult stem cells have many supporters; many doctors, patients and scientists who want to see adult stem cells available in the US. One of those supporters doing battle on the front lines is Chris Centeno, M.D. of Regenerative Sciences. The FDA and Centeno have been doing battle for quite some time now…
Here is a letter from Chris Centeno, M.D. of Regenerative Sciences dated February 11, 2009 9:47:00 AM PST:
To set the record straight, the FDA sent us an “untitled” letter, not a warning letter. Their own information states that such a letter is to be sent when the FDA is unsure of it’s regulatory authority. We responded to this letter some 6 months ago and the FDA has not responded to our answers to their concerns.
We run a state of the art medical facility that has undergone a full, voluntary Reglera cGTP review and passed with flying colors. The medical procedure performed within our facilities compares very favorably with the ISSCR guidelines. While you bring up some interesting points, embryonic stem cell expansion is performed everyday in countless non-FDA regulated In-vitro Fertilization labs in the US, without issue. The practice of culture expanding autologous bone marrow cells to reconstitute the immune system of irradiated cancer patients is just beginning, again without FDA involvement and usually under the auspices of state regs.
Our procedure was first successful in a university based, large animal model. We spent a year porting that to human patients under the auspices of an Institutional Review Board (IRB).. We began treating commercial patients only after an additional year of IRB approved research (which continues). We don’t add new areas of treatment until after our research has shown imaging and patient reported evidence of efficacy and safety. As a concrete example, my initial interest as a pain management specialist was treating lumbar degenerative discs. However, just copying the successful animal model into humans didn’t work. It took three years of tweaking the procedure until we could get it to work reliably in a subset patients. Hence the procedure for discs wasn’t begun on commercial patients until recently and then only with specific inclusion criteria. As a result of these experiences of what will likely work and what won’t work, we categorize all patients as either GOOD, FAIR, or POOR candidates based on pathology. As an example, only about 25% of our joint patients are prospectively placed in the GOOD category, 50% in FAIR, and 25% in POOR.
We also employ a nurse to maintain a patient tracking database that is >3 years old and now contains 200+ patients, 50 or so of these have also had pre and multiple post-op 3.0T MRIʼs of the transplant sites. This safety data has been submitted for scientific publication. So while I donʼt dispute that like anything in medicine, practitioners can enter the field who may not be reputable (i.e. a surgeon who is not well trained or an IVF lab opening that doesnʼt do a good job of handling cells), we take our practice of medicine very seriously.
Chris Centeno, M.D.
I suppose it was inevitable that the FDA come after Regenerative Sciences. -dg
FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product
Violations of current good manufacturing practice and labeling requirements cited
SILVER SPRING, Md., Aug. 6 /PRNewswire-USNewswire/ The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP) that cause its cultured cell product to be adulterated. The product is also misbranded due to the lack of adequate directions for use and the failure to bear the “Rx only” symbol.
The company’s cultured cell product is derived from a patient’s bone marrow or fluid surrounding the patient’s joints (synovial fluid). The cells are grown, processed, and mixed with drug products outside the body before being injected back into the patient.
Regenerative Sciences’ cultured cell product is not approved by the FDA, and no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication.
“FDA recognizes the importance of the development of novel and promising new therapies,” said Karen Midthun, M.D., acting director of FDA’s Center for Biologics Evaluation and Research. “However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public’s health at risk.”
The complaint for the injunction was filed Aug. 6, 2010, by the Justice Department on behalf of the FDA in the U.S. District Court for the District of Columbia, against Regenerative Sciences and three of its employees, Christopher J. Centeno, M.D., John R. Schultz, M.D., and Michelle R. Cheever. The injunction would permanently prevent the company and cited individuals from adulterating and misbranding the cultured cell product while the product, or one or more of its components, is held for sale after shipment in interstate commerce.
Regenerative Sciences has agreed to cease production of the cultured cell product while the case is pending.
The FDA warned Regenerative Sciences about its cGMP violations as recently as June 2010. The company failed to make sufficient corrections, and the conduct of the individuals cited in the complaint demonstrates refusal to comply with the law.
So, what was Regenerative Science’s response to this attack? -dg
Colorado Medical Clinic Welcomes Opportunity to Fight FDA in Court
Clinic Claims FDA Has Repeatedly Overstepped Regulatory Authority
Denver, CO – August 9, 2010 – 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 today that the US 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.
“If physician practices and hospitals must now use the same standards as drug manufacturers, the public can almost certainly expect medical care costs to skyrocket without any measurable impact on safety,” stated Centeno. 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 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 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 breakthrough 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. Regenerative Sciences believes in educating patients, providing choices, offering options and encouraging people to take an active role in their own treatment. More information can be found at http://www.regenexx.com