Health officials to police risky stem cell offerings set

WASHINGTON U.S. health authorities announced plans Thursday to crack down on doctors pushing stem cell procedures that pose the gravest risks to patients amid an effort to police a burgeoning medical field that previously has received little oversight.

The Food and Drug Administration laid out a strategy for regulating cellbased medicine, including hundreds of private clinics that have opened across the nation in the last decade. Many of the businesses promote stem cell injections for dozens of diseases including arthritis, multiple sclerosis and even Alzheimer’s. They can cost $5,000 to $50,000, but there’s little research that such procedures are safe or effective.

Researchers for years have called for a crackdown. FDA officials said they will focus their enforcement efforts on “bad actors” who inject stem cell mixtures into the bloodstream, nervous system or eyes. Regulators say those procedures pose the biggest risk to patients.

“We’re going to be prioritizing places where we see products — not just being promoted inappropriately — but putting patients at potential risk,” FDA Commissioner Scott Gottlieb told reporters.

Gottlieb said the agency plans to use discretion in overseeing lower-risk procedures such as injections for achy joints, adding that this approach would allow the agency to get the “most bang for our regulatory buck.” He also said the agency needs to be “nimble and creative” in its regulation to encourage legitimate researchers in the field.

Most new clinics offer adults stem cells isolated from fat. Practitioners collect fluid from patients via liposuction, treat it with chemicals and inject it back into the body.

Three Florida women were left nearly or completely blind by one such procedure, according to a report published this year in the New England Journal of Medicine. The Florida Board of Medicine previously revoked the license of another stem cell practitioner after two patients died under his care after receiving IV drips of stem cells to the bloodstream.

In August the FDA took action against clinics in Florida and California. The agency issued a warning letter to Sunrise-based US Stem Cell Clinic for marketing unapproved procedures for heart disease, Parkinson’s disease and other conditions. And the U.S. Marshals Service, under FDA instructions, seized vials of an unproven vaccine from StemImmune Inc. of San Diego.