Dr. Sonye K. Danoff, a pulmonologist at Johns Hopkins Medicine, said she saw two patients several years ago with severe lung disease who had been lured to clinics in Florida. Their blood was drawn, then “hocus-pocus happened,” she said, and the blood was infused back into them.
It had no apparent effect, and both patients, who paid from $15,000 to $20,000 out of pocket for the treatment, wound up feeling they had been scammed. Both eventually died of lung disease.
“They are preying on people who are desperate,” Dr. Danoff said. “Just yesterday, in clinic, I had a patient say, ‘Hey, I saw an ad for this place, they give you this cell treatment that makes you better.’ This is an incredibly deceptive practice.”
Dr. Knoepfler and Dr. Turner both suggested that the court ruling could prompt some stem-cell businesses to open clinics overseas. One company, Regenexx, set up a clinic in the Cayman Islands after it lost a court case and was forbidden to treat patients with bone-marrow stem cells that it was culturing to increase their numbers. (The F.D.A. considers culturing and multiplying the cells in the lab risky, because it might lead to mutations, even cancerous cells.)
A Texas company, Celltex, which uses fat and cultures the cells, moved its treatments to Mexico after receiving warnings from the F.D.A. It still makes the fat extracts in Texas, but patients must then travel to Cancun, Mexico, for treatment.
Dr. Aaron S. Kesselheim, a professor of medicine at Harvard Medical School who also teaches at Yale Law School, said: “It is a good sign that the F.D.A. can make a successful argument to a judge that this particular procedure crosses the line. It’s also good because there are substantial risks associated with this procedure.”
The ruling should also put other clinics on notice, he said. But he added that the F.D.A. needs more resources to pursue additional cases because clinics are in business with little oversight.