The FDA is taking aim at stem cell clinics using unproven and potentially hazardous treatments.
As part of the crackdown, the FDA seized vials of an unapproved vaccine from San Diego-based StemImmune. The treatments had been injected into cancer patients with potentially compromised immune systems at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills.
The live vaccinia virus vaccine, which could cause swelling of the heart, was injected both intravenously and directly into patient's tumors. The vaccine is typically used for patients at risk for contracting smallpox and has not been approved as a cancer treatment,
"The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work," said FDA Commissioner Scott Gottlieb, MD. "I especially won't allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse."
In addition to targeting the clinics using these unproven treatments in California, the FDA sent a letter to Sunrise, Fla.-based US Stem Cell Clinic, warning the clinic that it is violating federal regulations and risking patient's health and safety.
The FDA letter outlines deficiencies identified during an investigation at US Stem Cell Clinic, including failure to maintain records of equipment cleaning, not testing stem cell products for bacteria and not having proper FDA permits to offer its treatment.
US Stem Cell Clinic administered an unapproved, potentially hazardous stem cell product, which contained stem cells derived from adipose tissue, intravenously or directly into patients' spinal cords to treat Parkinson's disease, amyotrophic lateral sclerosis, heart disease and pulmonary fibrosis.
US Stem Cell must respond to the FDA within 15 days or they will face regulatory action.
"I've directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk," said Dr. Gottlieb.