STAT November 8, 2021
In 2016, the Food and Drug Administration put the emerging stem cell cottage industry on notice. At the time, a few hundred clinics were peddling experimental stem cell therapies costing between $2,000 and $25,000 for conditions ranging from chronic pain to autism to multiple sclerosis without solid scientific evidence that they worked. Federal regulators asserted that the stem cells being sold — usually taken from a patient’s body and slightly processed before being re-injected — were drugs, and therefore required a rigorous approval process.
After contentious public hearings, the agency offered a sort of compromise. For three years, starting in November of 2017, regulators would exercise “enforcement discretion.” In other words, mostly look the other way. The idea was to...
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