Pharmaceutical

FDA cracks down on stem cell treatment center

antibiotics vials test tubes FDA cracks down on stem cell treatment center U.S. Marshals, acting on behalf of the Food and Drug Administration (FDA), seized five vials of a commercially unavailable smallpox vaccine from StemImmune Inc., in San Diego, California, in order to prevent the company from using it as a potentially dangerous and unproven treatment for patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.

The vaccine, Vaccinia Virus Vaccine (Live), is reserved only for people at high risk of smallpox, like some members of the military. Since the vaccine is not commercially available, the FDA said has serious concerns about how StemImmune obtained the product for use as part of an unapproved and potentially dangerous treatment. The FDA also said it is actively investigating the circumstances by which StemImmune obtained the vaccine.

StemImmune Inc. and the California Stem Cell Treatment Centers confirmed that the vaccine was mixed with stem cells derived from body fat to create an unapproved stem cell product that was then administered to cancer patients, some of whom may have had compromised immune systems. These unproven treatments were being injected intravenously and directly into patients’ tumors. This put patients at risk for serious health complications including myocarditis and pericarditis (inflammation and swelling of the heart and surrounding tissues), the FDA said.

Serious and life threatening health problems can also occur in unvaccinated people who are accidentally infected with the vaccine virus by being in close contact with someone who has recently received the vaccine. Pregnant women, or individuals who have problems with their heart or immune systems, or have skin problems such as eczema, dermatitis, psoriasis who have close contact with a vaccine recipient are at increased risk of inflammation and swelling of the heart and surrounding tissue if they become infected with the virus, either by being vaccinated or by being in close contact with a person who was vaccinated, the FDA said.

“Speaking as a cancer survivor, I know all too well the fear and anxiety the diagnosis of cancer can have on a patient and their loved ones and how tempting it can be to believe the audacious but ultimately hollow claims made by these kinds of unscrupulous clinics or others selling so-called cures,” said FDA Commissioner Scott Gottlieb, M.D. “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. 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.”

Gottlieb said he has directed the agency to vigorously investigate these kinds of unscrupulous clinics through regulatory enforcement or criminal investigations. “Our actions today should also be a warning to others who may be doing similar harm,” he said. “We will take action to ensure Americans are not put at unnecessary risk.”

Source: FDA News Release