Dr. Sonye Ok. Danoff, a pulmonologist at Johns Hopkins Medicine, mentioned she noticed two sufferers a number of years in the past with extreme lung illness who had been lured to clinics in Florida. Their blood was drawn, then “hocus-pocus happened,” she mentioned, and the blood was infused again into them.
It had no obvious impact, and each sufferers, who paid from $15,000 to $20,000 out of pocket for the therapy, wound up feeling that they had been scammed. Both finally died of lung illness.
“They are preying on people who are desperate,” Dr. Danoff mentioned. “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 each advised that the courtroom ruling might immediate some stem-cell companies to open clinics abroad. One firm, Regenexx, arrange a clinic within the Cayman Islands after it misplaced a courtroom case and was forbidden to deal with sufferers with bone-marrow stem cells that it was culturing to extend their numbers. (The F.D.A. considers culturing and multiplying the cells within the lab dangerous, as a result of it’d result in mutations, even cancerous cells.)
A Texas firm, Celltex, which makes use of fats and cultures the cells, moved its remedies to Mexico after receiving warnings from the F.D.A. It nonetheless makes the fats extracts in Texas, however sufferers should then journey to Cancun, Mexico, for therapy.
Dr. Aaron S. Kesselheim, a professor of drugs at Harvard Medical School who additionally teaches at Yale Law School, mentioned: “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 must also put different clinics on discover, he mentioned. But he added that the F.D.A. wants extra sources to pursue extra circumstances as a result of clinics are in enterprise with little oversight.