A federal court found that the U.S. Food and Drug Administration (FDA) has the authority to regulate a procedure that uses patients’ adipose tissue to create a stem cell treatment, and ordered a Florida stem cell clinic to halt the practice after at least four people were blinded by injections administered into their eyes.
The order comes as the FDA amplifies its efforts to curtail a growing industry that is already under fire from the scientific and medical community. Regulators contend that clinics have sold unproven stem cell-based treatments for an array of ailments that the doctors these clinics employ often aren’t qualified to treat, from neurological and orthopedic diseases to respiratory and ophthalmologic conditions. The three-year grace period during which businesses can come into compliance with FDA regulations ends in 2020.
Another violation that might help regulators reign in unscrupulous clinics is improper physician supervision. A recent study in the Journal of the American Medical Association focused on 166 companies in three states.
“About half of the companies we examined offer unproven stem cell treatments for conditions where they do not have a physician with the appropriate residency and fellowship training to treat those conditions,” said lead researcher Zubin Master, PhD, associate professor of biomedical ethics at the Mayo Clinic.