The Food and Drug Administration plans to more strictly regulate some stem-cell treatments offered by private clinics, the agency announced Thursday.
The FDA’s move “closes a giant loophole,” as the Los Angeles Times‘ Michael Hiltzik puts it. The law says that, if a clinic takes biological material from a person—say by liposuctioning a bit of fat—and then injects that material back into the same person without changing the material significantly, then the clinic isn’t subject to certain rules. The idea is that someone’s own tissue is unlikely to pose a danger to herself, so there’s less need for strict regulation. In new documents, the FDA specifies which procedures it will continue not to regulate, and which ones it will crack down on.
Under the new rules, a recent procedure at a Florida clinic that left three elderly women blind would have been outlawed from the start. U.S. Stem Cell Clinic treated the women, who had macular degeneration, by injecting into their eyes stem cells that clinic staff had isolated from the women’s own belly fat. Researchers have since hypothesized that either the stem cells may have caused the women’s retinas to detach, or the injection was contaminated with enzymes that U.S. Stem Cell Clinic used in its stem-cell-isolating procedures. On Thursday, the FDA specified that, if a clinic treats a tissue with enzymes, it will come under stricter oversight. The same is true if the clinic purports to treat illnesses using cells that are totally unrelated to the illness—like using belly fat cells to treat macular degeneration, an eye disease.
“Alongside all the promise [of stem-cell-based medicine], we’ve also seen products marketed that are dangerous and have harmed people,” FDA Commissioner Scott Gottlieb said in a statement. “With the policy framework the FDA is announcing today, we’re adopting a risk-based and science-based approach that builds upon existing regulations to support innovative product development while clarifying the FDA’s authorities and enforcement priorities.”
