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Stem cells are drugs, it鈥檚 official. At least that鈥檚 the opinion of the US district court in Washington DC, which has ruled that clinics offering unproven stem cell therapies can be government-regulated.
Treatments in which stem cells are harvested from bone marrow and injected straight back into the same person are not regulated by the Food and Drug Administration. But if the cells are subject to more than 鈥渕inimal manipulation鈥�, the FDA says the therapy becomes a drug, which it has to approve for use. On this basis the FDA began moves in 2008 to shut down Regenerative Sciences, a clinic in Broomfield, Colorado, that treats orthopaedic problems using a stem cell therapy called Regenexx.
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The clinic challenged the FDA鈥檚 right to regulate its activities. Then in 2010, the FDA sought an injunction to take Regenexx off the market. That has now been granted and will allow the FDA to step up its efforts to regulate other such therapies.