FDA Wins Case against Stem-Cell Clinic that Blinded Patients with Bogus Treatment
A federal court ruled that the FDA has regulatory authority over these stem-cell procedures and the power to halt them.
Clinics offering unproven stem-cell therapies for retinal diseases and a variety of other conditions have proliferated throughout the U.S. and in a number of other countries around the world. The clinics have claimed that their treatments, often derived from the patients’ fat tissue or bone marrow, were exempt from regulation by the US Food & Drug Administration (FDA) or other regulatory agency. As a result, the treatments were not properly vetted, putting patients at risk of serious adverse events.
In 2015, a clinic known as US Stem Cell Clinic LLC in Florida gave eye injections to three patients with age-related macular degeneration (AMD) using their own fat cells. The treatment caused severe vision loss for these patients.
On June 3, 2019, a federal court ruled in favor of the FDA for a lawsuit it filed against US Stem Cell Clinic LLC for providing the treatment without FDA approval. The ruling confirms that the FDA does have regulatory authority over these stem-cell procedures and the power to halt them.
While emerging stem-cell-derived therapies have moved into regulated clinical trials for inherited retinal diseases and AMD — under the oversight of the FDA and European Medicines Agency (EMA) — none have progressed to the end of those trials and received regulatory marketing approval.
“A major red flag for the consumer is when a clinic charges several thousands of dollars for a stem-cell-derived treatment,” says Brian Mansfield, PhD, executive vice president research and interim chief scientific officer at the Foundation. “Consumers should never have to pay for an emerging treatment that’s in a clinical trial authorized by the FDA.”
A major red flag for the consumer is when a clinic charges several thousands of dollars for a stem-cell-derived treatment. Consumers should never have to pay for an emerging treatment that’s in a clinical trial authorized by the FDA.
Dr. Mansfield adds that just because a study or treatment is listed at www.ClinicalTrials.gov, a site hosted by the National Institutes of Health, doesn’t mean it is regulated. “ClinicalTrials.gov is an excellent source of information for FDA-authorized clinical trials for retinal diseases and a variety of other conditions, but unfortunately, trials not FDA-authorized are listed, as well. When participating in a legitimate clinical trial, patients will be given an informed consent to review and sign. The informed consent will list the potential risks and benefits of participation. And patients should review this information with their own clinician before agreeing to enroll.”
Though the court ruling confirms that the FDA has the power and authority to regulate these unproven treatments, many clinics are expected to continue to provide them to patients until they are challenged by the FDA.
If you have questions about a clinical trial or potential therapy, contact an eye care professional you know and trust.
As mentioned before, never pay for a therapy that is not approved by the FDA or EMA. Also, never participate in a clinical trial that doesn’t have FDA or EMA oversight.
If you have additional questions, contact the Foundation at email@example.com.