How should we regulate treatments that use cells taken from a patient’s own body?
If the cells are grown in culture, then the US Food and Drug Administration (FDA) views them as “drugs”, which must undergo a lengthy approval process. However, there is minimal oversight of clinics that don’t culture cells, because simple transplants are a “practice of medicine”, which the FDA doesn’t control.
This incoherent situation arises from trying to shoehorn stem cells into a regulatory system designed for conventional drugs. One solution would be to create a new body to regulate all therapies that use a patient’s own cells.
Obvious as this sounds, it is unlikely to happen in a political climate that has little enthusiasm for costly new bureaucracy.
Read the full, original story here: Whose stem cells are they anyway?
