FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product

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.

Aug 9 2010 --- 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.

According to the FDA, 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, the FDA claimed.

“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.

Christopher J. Centeno, M.D., the clinic's medical director noted that they have been involved in a two year dispute with the agency over whether it has the legal authority to regulate any part of a medical practice, an activity where congress and the courts have repeatedly prohibited FDA's involvement. "This dispute began in 2005-2006 when we received multiple legal opinions stating that FDCA did not apply to our clinical use of stem cells (at that time an IRB approved study).  After receiving a untitled letter from the agency in 2008, we sued the FDA four times in federal court in an attempt to have them either state the laws that they were relying on to regulate our medical practice, take some action, or leave us alone," Centano said.

"The FDA's position on the patient's own stem cells is that they are drugs.  Making these cells drugs isn't going to make them any safer or help patients any sooner.", Centeno said.

"Our lab is ICMS certified and doesn't follow drug mass manufacture guidelines, just like an in-vitro fertilization lab doesn't follow FDA drug factory guidelines.  Following drug factory guidelines won't make this medical procedure measurebaly safer for our patients.", stated Centeno.

"We have published a study with 227 patients and are submitting another with 339, that shows that our stem cell based procedure is dramatically safer than the more invasive surgical procedures it helps many patients avoid.  So while FDA mentions lack of adherence to drug factory guidelines, we don't make drugs, but treat patients.", stated John Schultz, M.D. a clinic founder.

"We have been trying to force the agency into court for two years and they have refused to discuss why a medical clinic practicing medicine using a patient's own tissue is producing a drug that is regulated by the FDCA.  They will now be forced to show up and answer these questions.  We welcome the opportunity to have this critical issue decided-are our patient's stem cells when used in our medical practice drugs or body parts?", Centeno concluded.