In a major move against unproven stem cell treatments, the U.S. Food and Drug Administration (FDA) did a major crackdown today, coming down on “the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc.” by seizing vials of its vaccine.
The San Diego–based company operates in Beverly Hills and Rancho Mirage, CA, and, according to the website, offers “stem cell–based immunotherapies for cancer.”
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“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, MD. “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.”
According to the FDA’s statement, the “seizure comes after recent FDA inspections at StemImmune Inc. and the California Stem Cell Treatment Centers confirmed that the vaccine was used to create an unapproved stem cell product (a combination of excess amounts of vaccine and stromal vascular fraction—stem cells derived from body fat), which was then administered to cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm, including myocarditis and pericarditis (inflammation and swelling of the heart and surrounding tissues). The unproven and potentially dangerous treatment was being injected intravenously and directly into patients’ tumors.”
The FDA also urges anyone who may have any adverse effects related to treatments received at California Stem Cell Treatment Center to report them to the FDA’s MedWatch.