FDA Plays Hardball With Two Stem Cell Clinics

May 15, 2018By Mark I. Schwartz

The U.S. Food and Drug Administration, in two complaints (here and here) filed last week in federal court, is seeking permanent injunctions to prevent two stem cell clinics from marketing stem cell products without FDA approval.

Specifically, a permanent injunction is being sought against US Stem Cell Clinic LLC of Sunrise, Florida, its Chief Scientific Officer Kristin Comella and its co-owner and managing officer Theodore Gradel for allegedly marketing stem cell products to patients without FDA approval and for allegedly violating current good manufacturing practice requirements, including, according to FDA, some that could impact the sterility of their products, thereby allegedly putting patients at risk.

The FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; the Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D. personally, from marketing stem cell products to patients without FDA approval. Berman and Lander allegedly control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center.

As you may recall, on August 28, 2017, we blogged about the fact that the U.S. Marshals Service, on behalf of FDA, had seized vials of Vaccinia Virus Vaccine (Live) from StemImmune Inc. in San Diego, California. These vaccines were purportedly being administered to cancer patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.

According to the FDA press release at the time: “…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.”

At around the same time as this seizure, the agency had issued a Warning Letter to the U.S. Stem Cell Clinic Inc., LLC, alleging that the autologous stem cells manufactured at this clinic from adipose tissue were more than minimally manipulated and not intended for a homologous use, thereby rendering the products unapproved new drugs, and biologics requiring licensure under 351 of the Public Health Service Act (PHSA). It was alleged that these products were intended by the U.S. Stem Cell Clinic to treat a variety of diseases and conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease, and pulmonary fibrosis. In March of 2017, the clinic was the subject of a New England Journal of Medicine article that stated that three women with age-related macular degeneration were blinded, or had their vision badly impaired, after undergoing procedures at the U.S. Stem Cell Clinic which involved injecting stem cells into their eyes.

At the announcement of the federal complaints seeking these injunctions, FDA Commissioner Scott Gottlieb, M.D. stated that: “[c]ell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk. In some instances, patients have suffered serious and permanent harm after receiving these unapproved products. In the two cases filed today, the clinics and their leadership have continued to disregard the law and more importantly, patient safety. We cannot allow unproven products that exploit the hope of patients and their loved ones…”

We support sound, scientific research and regulation of cell-based regenerative medicine, and the FDA has advanced a comprehensive policy framework to promote the approval of regenerative medicine products. But at the same time, the FDA will continue to take enforcement actions against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by purporting to have treatments that are being manufactured and used in ways that make them drugs under the existing law but have not been proven safe or effective for any use.

After many years of limiting itself to issuing Warning Letters to unlicensed stem cell firms, even when the firms did not heed FDA’s admonitions and continued to treat patients, it is now clear that FDA is willing to take legal action, at least in instances where there appears to be evidence that patients may have been harmed (as with the allegations regarding the U.S. Stem Cell Clinic), or may imminently be harmed (as with the allegations regarding California Stem Cell Treatment Center).