Stem cell companies in the USA challenged by the FDA as patients run out of time
Americans seeking stem cell replacement therapy hope the process can heal them of myriad diseases, and a 2011 report by the Baker Institute estimated the industry could bring in $16 billion in revenue by 2020.
But the Food and Drug Administration has expressed concerns.
The agency sued to stop treatments at a Regenerative Sciences clinic in Colorado and closed the lab of another company, Celltex Therapeutics, in Texas.
Celltex is keeping a research arm open in the United States, but the large part of the company is headed to Mexico, Ferrenz says, where it’s opening a new clinic to expand the growing business. “COFEPRIS, Mexico’s equivalent of the FDA, is as concerned with safety for the people in its country as the U.S. FDA,” she says.
Regenerative Sciences, a medical company that pioneered a procedure to treat orthopedic injuries using patients’ own stem cells, is fighting the FDA – Food and Drug Administration tooth and nail over a claim that human cells should be federally regulated as drugs, in a landmark case that has far-reaching implications for the future of regenerative medicine.
“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,” said Dr. Christopher Centeno, director of the Colorado clinic, in a telephone interview. “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?”
While patients in dire situations are willing to try the therapy (and pay the hefty costs), there’s concern the research doesn’t support broad practice just yet.