Sun Sentinel Palm Beach Edition
Stem cell clinic warned by FDA
Rules violated, feds say
The U.S. Food and Drug Administration on Monday said U.S. Stem Cell Clinic in Sunrise, which had three patients suffer severe vision loss after stem cells were injected into their eyes, is violating federal regulations.
In a warning letter to the clinic’s chief scientific officer, Kristin Comella, the agency said U.S. Stem Cell does not have proper FDA permits to offer its experimental medical treatments. The clinic must respond to the FDA within 15 days or face regulatory action.
The clinic markets to patients nationwide who pay thousands of dollars to have stem
cells harvested from their own body fat or bone marrow and reinjected into their bodies. The procedures have not been proven safe or effective by FDA standards.
Three women in their 70s and 80s with macular degeneration, all from outside South Florida, paid $5,000 each for stem cell injections in both eyes in 2015. They all had retinal detachments shortly after their procedures at U.S. Stem Cell. Two of the women sued for negligence, failure to warn, and allegations regarding how the product manufactured from their own bodies was defective. Both settled, and their cases were dismissed. Attorneys for U.S. Stem Cell argued that the cases, as filed, involved medical negligence and, as such, needed to be refiled to conform with state law, according to court records.
A New England of Journal of Medicine article profiled the three cases in March. The clinic stopped treating eye disorders.
The FDA letter documented sanitary violations that inspectors found at the clinic in April and May. These included: failing to maintain records of major equipment cleaning and maintenance; and not appropriately testing each batch of the clinic’s stem cell products for toxins and microorganisms. Some of the incidents stretched back to 2015.
The letter also said Comella “impaired their ability to conduct the AprilMay 2017 inspection” by not allowing investigators to speak with employees and refusing to allow entry to the clinic without an appointment.
In a written statement Monday afternoon, U.S. Stem Cell Clinic said it “will and does abide by all FDA requirements,” while at the same time denying it needed an investigational permit for its stem cell products. The statement also said the clinic “has never had a breach of sterility.”
“Since November 2014, we have offered the FDA unrestricted access to our facilities and our processes,” according to the clinic’s statement. U.S. Stem Cell will be switching to a new system to process tissue in the clinic and “work with the FDA to establish protocols going forward,” the statement added.
The warning letter came as FDA Commissioner Dr. Scott Gottlieb on Monday announced his agency will be stepping up its scrutiny of for-profit stem cell clinics nationwide, which claim to treat everything from erectile dysfunction to retinal disorders to multiple sclerosis.
The FDA also said it took action against two for-profit clinics in southern California. The centers were giving cancer patients injections of a vaccine typically used for patients at high risk for smallpox, according to the FDA.
“We can’t let a small number of unscrupulous actors poison the well for the good science that holds the promise of changing the contours of human illness,” said Gottlieb in a written statement. “Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk.”
He said the FDA will seek to take additional actions.
However, Gottlieb also said the agency wants to craft policies that will make it more efficient and less costly for “responsible product developers” to gain FDA approval.
Leigh Turner, a University of Minnesota bioethicist who has published peer-reviewed research on for-profit stem cell clinics, said it’s too early to tell what impact Gottlieb’s statements and the warning letters might have.
“The FDA seems to recognize that there are these bad actors, and they need to deal with them,” said Turner, who has been critical of the for-profit stem cell industry. “On the other hand, people have said before that a crackdown was imminent. And nothing much has happened.”
Turner said any new federal policies would need to be very clear regarding which types of drugs and biological products (such as human tissue) require FDA approval before being marketed to the public.
For-profit stem cell clinics are largely unregulated by Florida’s health-care agencies, which say the authority lies with the FDA. Most don’t need a medical facilities license, like hospitals or outpatient centers do, although the state Department of Health does license and regulate the health-care personnel employed there.
These businesses, including U.S. Stem Cell Clinic, repeatedly have said they do not need FDA permits or oversight because their specific procedures — in which they draw adult stem cells from a patient’s fat, bone marrow or blood and then reinject these back into the same patient — aren’t covered under FDA regulations.
In its statement Monday, U.S. Stem Cell reaffirmed that the clinic “is not manufacturing a drug” and therefore not required to follow such regulations. The clinic had said the same thing on May 16, when following up with the FDA on problems found in the April-May inspections.
FDA investigators had noticed similar non-compliance issues in late 2015, according to the warning letter.
Critics, such as the International Society for Stem Cell Research, say the industry has exploited this loophole, making money selling unproven procedures and targeting desperate patients who have exhausted traditional medical treatments.
In recent years, the number of these for-profit stem cell clinics has exploded, Turner said. Florida and California are hotspots. A 2016 report by Turner and Paul Knoepfler, a biomedical engineer at the University of California-Davis, on the growing number of these clinics nationwide found California had the most with 113, followed by Florida with 104. The third-highest was Texas, with 71.
Turner said he thinks those numbers are much higher today and, depending on what happens in the next few months, could grow even more.
“If there’s no regulatory activity, it would be an inducement for clinics to set up shop,” Turner said.
However, if the FDA does take action, “there may be some people who don’t want to take the risk,” he said.