Two stem cell clinics will “vigorously defend” their dubious treatments against civil suits levied this week by the Department of Justice at the request of the Food and Drug Administration.
The two clinics are no stranger to federal officials’ bad sides; they have both received warnings and wrist-slaps in the past.
The other clinic, California Stem Cell Treatment Center Inc. of Rancho Mirage and Beverly Hills, California, and affiliates—including StemImmune Inc. and Cell Surgical Network—were likewise chided by the FDA for inappropriately obtaining vials of smallpox vaccine from the Centers for Disease Control and Prevention. (The CDC maintains a stash of vaccines against the eradicated virus for research and emergency military purposes.) The clinic was mixing the vaccine into unproven, unapproved cell treatments for cancer and injecting it directly into patients’ tumors.
In this weeks’ filings, the DOJ alleged that both clinics were manufacturing stem cell treatments without FDA approval and proof of safety and efficacy were putting thousands of patients at risk and in some cases caused harm. The DOJ is seeking permanent injunctions against the two clinics in separate filings.
They both responded to the charges with vehement denials and vows to fight. US Stem Cell said in a statement that it would “vigorously defend” itself against the lawsuit:
The lawsuit seeks to stop US Stem Cell Clinic [OTC: USRM] and related parties from performing a surgical procedure using stem cells from autologous adipose tissue, even when a physician and patient agree that such a procedure is in the best interest of the patient. USRM believes that the patient and physician have the right to decide whether or not to use a patient’s own cells for a therapeutic purpose without federal government interference.
Pesky regulations
US Stem Cell’s CSO Comella added in a separate statement: “I remain steadfast that no government agency should deprive individuals of their right to harness the cells that exist in their body.”
An affiliate for the California clinic also said they would “vigorously defend” against the charges. “[The clinic] strongly rejects the idea that a person’s own cells should be regulated by FDA as a drug,” it said in a statement.
The crux of the dispute is the wording “minimally manipulated.” FDA regulations state that treatments using cells from an individual patient for that patient are exempt from approval if they’re “minimally manipulated.” Both clinics will likely argue that the cell-based treatments fit that description.
The clinics, like the other hundreds of shady stem cell clinics that have bubbled up across the country, collect fat cells from patients, treat or process them in some way to supposedly coax out stem cells, then inject them back into the patient. There’s no evidence that this common technique is safe or effective for the slew of disorders and diseases that the clinics claim to treat (although there are legitimate research efforts investigating the possibility). Yet US Stem Cell claims its injections treat Parkinson’s disease, spinal cord injuries, stroke, pulmonary disease, and traumatic brain injury among others. The Californian clinic claims its injections treat cancer, pulmonary disease, arthritis, stroke, ALS, and multiple sclerosis, among others.
The clinics argue that they’re simply “utilizing the body’s own natural ability to heal.” But the FDA and DOJ see things differently.
“Marketing unproven and potentially unsafe treatments puts consumers at risk,” Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division said in a statement. “The Department of Justice will continue to work with the FDA to make sure manufacturers of experimental therapies conduct their research within the safe and legal bounds for drug innovation.”
