LOS ANGELES — Federal regulators are preparing to crack down on scores of clinics across the United States that offer pricey stem cell therapies for conditions ranging from autism to multiple sclerosis to erectile dysfunction without any scientific evidence that they work.
As many as 200 stem cell clinics have cropped up in recent years, peddling injections, facelifts, and treatments for a number of devastating conditions. They 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.
But the Food and Drug Administration recently issued draft guidelines clarifying that the stem cells used in most clinics are drugs and require a rigorous approval process before they can be used in patients. A public hearing is set for April.
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