A U.S. federal court has found that a stem cell therapy offered by a Colorado clinic meets the definition of a regulated drug. The ruling could spur a U.S. Food and Drug Administration crackdown on other clinics offering untested adult stem cell treatments in the United States.
The company, Regenerative Sciences Inc. in Broomfield, Colorado, uses stem cells extracted from a patient's own bone marrow to treat bone and joint injuries. The company says its treatment is a medical procedure and not subject to federal oversight. But in a 2010 suit seeking to block the company from selling the treatment, the U.S. government argued that because Regenerative Science's stem cells are more than "minimally manipulated" and use reagents that cross state lines, the cells are an FDA-regulated biological drug.
In a 23 July ruling (first reported by New Scientist), the U.S. District Court for the District of Columbia in Washington, D.C., agreed that "the cultured cell product is a drug" according to federal law.
The ruling could have implications for stem cell clinics in Texas. In April, the Texas Medical Board approved the first-ever state policy to oversee experimental stem cell treatments. Critics said the policy would allow doctors to avoid rigorous review. But a board official, pointing to the pending suit against Regenerative Sciences, said state rules were needed because of uncertainty about FDA's authority to regulate stem cells.
Celltex, a stem cell bank in Sugar Land, Texas, involved in treating Governor Rick Perry (R-TX) with his own stem cells last summer, has also claimed that its cells it provides are not an investigational drug. In June, however, FDA found problems with Celltex's manufacturing process and described its product as a biological drug.
University of Minnesota bioethicist Leigh Turner says this week's court ruling "is particularly important given that we are witnessing within the US the proliferation of clinics marketing stem cell procedures," many of which "appear to be pushing stem cell quackery," he says.
Regenerative Sciences CEO Christopher Centeno told New Scientist that the company plans to appeal.