A federal judge has ordered a South Florida clinic to stop injecting patients with their own stem cells.
The Food and Drug Administration filed for the permanent injunction against U.S. Stem Cell in Sunrise. The judge’s decision could affect similar procedures at stem cell clinics across Florida and the country, officials said.
The order stops the clinic from performing the procedure until it comes into compliance with the law. It also sets legal precedent that the FDA can use when regulating other clinics that perform similar procedures.
Stem cell clinics have been popping up around Florida for years. Some, like U.S. Stem Cell in Sunrise, claim to take stem cells from fatty tissue in a patient’s abdomen. The cells are then injected into other parts of a patient’s body.
Clinics say the procedure can be used to treat conditions from torn ligaments to emphysema and multiple sclerosis. But there’s little scientific evidence of the procedure’s safety or effectiveness.
U.S. Stem Cell is accused of blinding three patients after injecting the fat extract into their eyes.
The Food and Drug Administration has regulated the clinics by sending warning letters and threatening litigation.
That’s what it did with U.S. Stem Cell. Then it asked a federal judge for an injunction.
The clinic had said that the procedure did not fall under the FDA’s regulatory authority because the injections contained the patient’s own cells.
Judge Ursula Ungaro, of the United States District Court for the Southern District of Florida, issued the injunction on Tuesday, concluding that the clinic adulterated and misbranded their products.
“Today’s action by Judge Ungaro is significant and sends a strong message to others manufacturing violative stem cell products,” the FDA said in a release. “Court decisions like this reaffirm the FDA’s compliance and enforcement efforts in the ongoing fight to protect the public from individuals and clinics who mislead patients with unapproved and potentially harmful medical products.”
The ruling means the clinic cannot perform the procedure unless it takes several specific steps to come into compliance with the FDA's standards.
“These actors are taking advantage of patients, many in vulnerable positions with chronic or terminal diseases, by leveraging the widespread belief in the eventual promise of these products, flouting the statutes and our regulations,” the agency said.
The FDA said it intends to bring more cases against clinics that perform similar procedures.
