From the article:
Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice - not regulated by the US government. But if the cells are subjected to more than "minimal manipulation", the FDA maintains that the therapy becomes a "drug", which must be specifically approved for use.It's not quite, "All your cells are belong to us". But it's getting there...
Related: "Ruling frees FDA to crack down on stem cell clinics".