Stem-Cell Treatments Become More Available, and Face More Scrutiny

In two days of hearings next month, the U.S. Food and Drug Administration will consider if clinics offering stem-cell treatments should be more closely regulated.

Stem-cell treatments aren’t approved by the FDA and not long ago, Americans had to travel to Mexico, China or elsewhere to receive them. Now, with the regulatory environment murky, clinics offering them are spreading rapidly across the U.S. A recent report in the journal Cell Stem Cell counted 570 clinics advertising stem-cell therapies directly to consumers. Many claim to treat a long list of disorders, from arthritis to Alzheimer’s disease, even though the stem-cell treatment for many of the conditions hasn’t yet been tested on humans. Treatment typically costs thousands of dollars.

Critics, including many top stem-cell scientists, say the clinics are peddling 21st century snake oil and want the FDA to crack down. Clinic operators say they don’t need FDA approval because they are practicing medicine, not creating new drugs. Some patients say they have been helped and that the government shouldn’t regulate what they do with their own cells.

Stem cells, found in...