Regenerative Sciences, a Colorado-based medical company, has locked horns with the Food and Drug Administration. Regenerative sciences developed a procedure, using patients' own stem cells, to tend to orthopedic injuries. They claim that human cells should be federally regulated as drugs, a statement that the FDA doesn't agree with. This is a landmark case that has implications regarding the future of regenerative medicine.
The technique, devised by Regenerative Sciences in 2005, involves the use of stem cells taken from the bone marrow to repair impaired joints. This procedure has been offered to the patients since 2007 and has mustered clinical evidence about its safety and efficiency. The legality behind it is being questioned by the FDA because the agency claims that the stem cells being used are more than minimally manipulated drugs.
Regenerative Sciences, in 2008, was accused by the FDA of introducing a new drug (stem cells) without obtaining a license for it, and Regenerative, in 2010, was sued to stop performing the procedure.
A number of clinics have licensed their physicians to provide Regenexx, a cell therapy, garnering interest of the consumers and patients. A harshly worded blog post was published on its Web site criticising the FDA's reasoning. The blog wrote that the lawsuit is "concerning for every American who considers their body not to be an FDA regulated drug factory."
While the treatment that is the focus of the lawsuit is not used for life-threatening injuries, the company claims this case goes beyond a particular procedure to shed light on a misguided push by the FDA to establish authority over aspects of medicine never allowed it by Congress.
Dr Christopher Centeno, the director of the Colorado clinic, said, "We see this lawsuit as a 21st century civil rights issue that will define what control you have about the use of your own cells and tissue. If a loved one is dying in intensive care and a well done study shows that the patient's own cells can be used to help, does the patient get to decide to use those cells, or is that a decision for the FDA? Will the patient still be alive while we wait on Washington to issue this decision?"
Michael Freeman, an academic at the Oregon Health Sciences University, has criticised the FDA for its assertion that the Regenexx procedure presents a public health risk. In his testimony, Freeman suggests that since the stem cells originate from the same patient into whom it are later re-injected, the treatment poses a lesser public health risk than that associated with current common medical practices and FDA-approved drugs. Clinical studies by physicians of the company catalogued in the U.S. National Library of Medicine state that this procedure leads to less severe complications when compared to the costlier and more invasive surgical procedures.
Stem cells that are re-injected into patients are equivalent to the administration of a drug, argued regulators. They say that the stem cells constitute an "article" that is considered to treat and cure diseases, therefore fit for the definition of a "drug."