Federal court rules against stem cell clinic
A federal court in Florida issued a decision holding US Stem Cell Clinic and their chief scientific officer, Kristin Comella, PhD, adulterated and misbranded a stem cell drug product make from a patient’s adipose tissue, according to an announcement by the U.S. Food and Drug Administration (FDA).
Thought to treat or prevent chronic diseases and injuries, stem cell therapy, or regenerative medicine, involves implanting specialized cells into a person. For example, if a person has heart disease, the cells could be injected into the heart muscle, and the healthy transplanted cells could then contribute to repairing defective heart muscle. A common form of this type of therapy is a bone marrow transplant.
Some clinics are performing fat-derived stem cell therapy, where a practitioner removes a small amount of a person’s fat, processes it, and inject it back into them. This is thought to jump-start the healing process. The therapy is not FDA-approved, though hundreds of clinicians and clinics across the U.S. offer fat-derived stem cell therapy, according to the Cell Surgical Network.
As previously reported on Integrative Practitioner, the FDA called on clinics to prove the safety and efficacy of fat-derived stem cell treatments through rigorous clinical trials. To make this feasible for small businesses, the agency announced a streamlined clinical trial process, where clinics can team up on trials and pool their patients to save time and money. At the time, the FDA said it was offering up to a 36-month grace period for clinics to comply with its guidelines. Clinics can continue to operate on patients without clinical trials for now, but the FDA is monitoring and warning patients to do their part to stay safe.
The U.S. Department of Justice, on FDA’s behalf, initiated this action against US Stem Cell Clinic and Comella in May 2018, seeking a permanent injunction to stop the defendants’ illegal behavior after several attempts to provide the clinic and the individual defendants the opportunity to work with the agency to come into compliance with FDA regulations and protect patients from harm.
The FDA initially raised concerns about US Stem Cell in a warning letter issued in 2017 for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, following an FDA inspection of the facility that found that the company was administering its product intravenously or via other methods of administration to treat a variety of serious diseases or conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease, and pulmonary fibrosis. The FDA has not approved any biological products manufactured by US Stem Cell Clinic for any use, according to the statement.
The clinic was also cited for its failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections.
Following these steps, a U.S. court previously entered a consent decree of permanent injunction agreed to by the FDA and defendant Theodore Gradel, a former manager of US Stem Cell, that requires Gradel to notify the FDA if he intends to re-enter the biologics industry and to comply with any corrective actions ordered by the FDA.
In a separate action, the FDA is also seeking a permanent injunction to stop the California Stem Cell Treatment Center, with locations in Rancho Mirage and Beverly Hills; Cell Surgical Network Corporation in Rancho Mirage, California; and Elliot B. Lander, MD and Mark Berman, MD, from marketing to patients cellular products without FDA approval. That litigation is ongoing.
“Cell-based regenerative medicine holds significant medical opportunity, but those in this field who do not operate in compliance with the law can potentially cause serious harm to patients,” said Ned Sharpless, MD, acting FDA Commissioner. “We support sound, scientific research and regulation of cell-based regenerative medicine. The FDA has advanced a comprehensive policy framework to promote the development and approval of regenerative medicine products. But at the same time, the FDA will continue to take action—such as issuing warning letters or initiating court cases—against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by manufacturing and promoting products in ways that make them drugs under the law, but which have not been proven to be safe or effective for any use. It is our responsibility to promote and protect public health, and we take this responsibility seriously.”