In an important ruling protecting public health, a federal judge in Miami on Monday backed the Food and Drug Administration in its campaign to rein in stem cell clinics offering unproven and potentially hazardous “stem cell” treatments of a long list of diseases.
Judge Ursula Ungaro handed a major defeat to U.S. Stem Cell Clinic, which has been fighting an FDA complaint that it was illegally administering therapies labeled stem cell treatments. She found that the FDA had acted properly in deeming the clinic’s purported stem cell treatments illegal, and issued an injunction against the continuation of the treatments. The ruling is subject to appeal.
The firm has claimed that its clinics have "shown positive results" in treating diabetes, multiple sclerosis, Parkinson's disease, brain trauma, chronic obstructive pulmonary disease (COPD), and even had produced "increased libido" in male patients.
None of those claims has been scientifically validated.
U.S. Stem Cell and its chief science officer, Kristin Comella, had responded to the FDA complaint by asserting that its treatments fell outside the agency’s jurisdiction. The firm’s method involves removing body fat from a patient by liposuction, treating it to extract what it says are stem cells, and reinjecting the extracted fluid into the patient.
The firm argued that because it is merely treating patients with their own tissues, its method fell within an exception from FDA regulations for “minimally manipulated” tissues or substances. The FDA said the product was sufficiently altered to make it a drug — and as U.S. Stem Cell used it, an illegal drug. To enforce its ruling, the FDA sued U.S. Stem Cell last year.
U.S. Stem Cell and Comella have been prominent adversaries of FDA regulations. Their histories reflect the questionable behavior of the entire field. As we documented last year, Comella’s claimed doctorate in “stem cell biology” was issued by the Panama College of Cell Science, a nonaccredited "virtual university" offering a three-year online PhD at a bargain-basement price of $2,950 a year — $2,700 if paid in advance.
U.S. Stem Cell has been sued over a series of procedures in 2015 reported in the New England Journal of Medicine in March 2017. The clinic treated three women for macular degeneration, an eye condition, by injecting liposuction-derived stem cells directly into their eyeballs. The procedure produced catastrophic damage to the patients' vision, including blindness in at least one case. Thomas Albini, the Miami ophthalmologist who examined the women after their treatments, told an FDA workshop in 2016 that the procedures demonstrated "a complete lack of regard to the patient safety and to any sort of scientific integrity."
Judge Ungaro in her ruling sided entirely with the FDA, which could strengthen the agency’s hand as it pursues enforcement against other clinics in this burgeoning field. Just last week, the agency placed an Arizona-based clinic chain on notice that it was giving patients unapproved treatments.
“We continue to see companies and individuals use questionable marketing campaigns to take advantage of vulnerable patients and their families with unproven claims about their unapproved stem cell products,” FDA Acting Commissioner Ned Sharpless said in announcing the action against R3 Stem Cell of Scottsdale. “The reality is that at this time, there isn’t enough evidence to support the use of stem cells for purposes other than reconstitution of blood formation and the immune system.”
Ungaro’s ruling could bode well for the FDA’s lawsuit against California Stem Cell Treatment Center and Cell Surgical Network, which are headquartered in Rancho Mirage and associated with more than 100 clinics nationwide. The agency charged the network with similar violations of federal law, and the clinics have responded also by claiming that their treatments are exempt from its regulation. That case is pending in federal court in Riverside.
Mark Berman, the co-owner of California Stem Cell Treatment Center and Cell Surgical Network, sounded a defiant note after Ungaro’s ruling was handed down. He said the procedures his firms perform are surgical rather than involving drugs subject to FDA oversight.
“We want to go to trial,” he told me. Trial is scheduled to begin Oct. 1 at the federal courthouse in Riverside. “The public is being bamboozled by the FDA.”
The FDA in an emailed statement called the Florida case “an important victory in the FDA’s work to protect the public health…. We will continue to promote the sound and scientific development of regenerative medicine products, but we will not tolerate those in this field who try to skirt the law and put patients in harm’s way.”
It is unclear whether Ungaro’s injunction against U.S. Stem Cell’s continued treatments will go into effect immediately. She based the injunction on the “reasonable likelihood” that the clinics would continue to violate the law without it. They have not ceased performing the treatments despite the FDA warning and failed to comply with the agency’s directives to tighten their quality control, which the agency said could expose patients to contaminated treatments, she observed.