U.S. Marshals operating on behalf of the Food and Drug Administration confiscated five vials of live vaccinia virus vaccine from two stem cell treatment centres in California last week. The seizure stem from concerns by the FDA that some clinics have been “targeting vulnerable patients” and offering them stem cell treatments which the FDA said were “unproven” and “potentially harmful.”
The seized vaccines are not commercially available and are reserved only for individuals at high risk of smallpox. They belonged to StemImmune Inc. of San Diego, Calif. and were being administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California., according to the FDA. Four of the vials were intact, however, a fifth was found to have been partly used. Each vial is supposed to contain approximately 100 doses of the vaccine.
“…the FDA has serious concerns about how StemImmune obtained the product for use as part of an unapproved and potentially dangerous treatment,” a press release from the federal agency charged with the control and supervision of food safety, pharmaceutical drugs, vaccines, and biopharmaceuticals. “The FDA is actively investigating the circumstances by which StemImmune came to possess the vaccine.”
StemImmune, which was founded in 2014, aims to develop stem cell-based immunotherapies for cancers that currently have no known cure. The company says its proprietary platform and delivery methods use the patient’s own stem cells “armed with potent, anti-cancer payloads” that attack cancer cells.
The company’s Web site indicates that StemImmune is working with the FDA on an investigational new drug application that would allow a Phase I and Phase II clinical trial of its leading drug candidate.
“StemImmune… is fully cooperating with the FDA about the development and use of its stem cell-based investigational cancer therapy,” the company said in an emailed statement to Laboratory Equipment. “Our primary concern has and continues to be the safety and well-being of patients in clinical trials and compassionate use programs. At this time, we are working to understand and address the questions raised by the FDA about the use of our therapy for cancer patients in individual compassionate use programs in clinics. As more information becomes available to us, we will update this statement.”
However, the FDA said the seizures came after a recent FDA inspection 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 FDA said the “unproven and potentially dangerous treatment was being injected intravenously and directly into patients’ tumors.”
Unvaccinated people who are accidentally infected with the vaccinia virus by just being in close contact with a person who has recently received the vaccine could develop serious if not life-threatening health problems, warned FDA Commissioner Scott Gottlieb.
Close contact with a vaccine recipient could be problematic for individuals who are pregnant or have heart or immune system conditions, or who have skin problems such as eczema, dermatitis, and psoriasis. They could be at risk of inflammation and swelling of the heart and surrounding tissues.
The FDA chief said the seizure at the StemImmune facilities should serve as a warning to other clinics “doing similar harm.”
“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 Dr. Gottlieb. “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.”