The Food and Drug Administration (FDA) launched a plan today to crack down on stem cell clinics claiming they offer treatments for a variety of diseases, but don’t provide any scientific evidence that they work.
Numerous firms over the years have “avoided heavy regulation, in part because they use cells extracted from a patient’s own body and because they don’t do much to those cells before reinjecting them,” writes STAT.
A warning letter issued by the agency at the end of December to several stem cell clinics advised owners FDA licenses and regulatory approval would be required to use these treatments. The note labeled these stem cells as a biological product.
Legislation like this would entail having corporate or independent entities offer supporting evidence that these drugs have a valid safety and efficacy profile.
Controversy has brewed around these institutions in the past as researchers revealed theyfabricated data surrounding their studies or when patients died from potentially illegal operations.
There are potential opportunities for refining stem cell treatments for difficult diseases like diabetes, but STAT notes that experts believe a full-fledged stem cell treatment is still years away.
The FDA scheduled a public hearing on stem cell clinic regulation in April.
