FDA goes after Sunrise stem cell clinic, says its patients are at risk

The U.S. Food and Drug Administration is seeking to prevent a controversial stem cell treatment clinic in Sunrise from treating patients with unapproved stem cell products.

U.S. Stem Cell Clinic LLC, accused of injecting thousands of patients with unapproved stem cell treatments, is a target of an injunction request filed Wednesday in U.S. District Court for the Southern District of Florida, according to a news release by the FDA.

The injunction is also being sought against the company’s chief scientific officer, Kristin Comella, and its co-owner and managing officer, Theodore Gradel, “for marketing stem cell products to patients without FDA approval and while violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting pa-

tients at risk.”

The release said the action is being taken because the company failed to address violations outlined in a warning letter the FDA sent to the clinic in August and “failed to come into compliance with the law.”

U.S. Stem Cell Clinic and similar for-profit clinics were subjects of a Sun Sentinel investigation about their use of aggressive marketing strategies to persuade people to spend thousands of dollars on unproven, unapproved and sometimes dangerous treatments. Examples of the dangers of the unregulated treatments included complications from the treatment of three elderly women with macular degeneration who each spent $5,000 to have stem cells harvested from their body fat and injected into their eyes at U.S. Stem Cell. The women said they lost vision after the June 2015 treatments, with complications including detached retinas and optic nerve damage.

The FDA’s August warning letter accused U.S. Stem Cell Clinic of marketing stem cell products without FDA approval and failing to use sterile practices. It cited an FDA inspection that found the clinic was processing body fat into a stem cell product and administering it intravenously or directly into the spinal cord of patients to treat a variety of serious diseases or conditions, including Parkinson’s disease, ALS (Lou Gehrig’s disease), chronic obstructive pulmonary disease, heart disease and pulmonary fibrosis.

The unapproved treatments were used on thousands of patients, according to a news release by the U.S. Department of Justice.

The FDA has not approved any biological products manufactured by U.S. Stem Cell Clinic for any use, the FDA release said.

Evidence of deviations from “good manufacturing practices” was discovered in the manufacture of at least 256 lots of stem cell products by the clinic, and it was also cited for failing to establish written procedures to prevent microbiological contamination of products purporting to be sterile, “which puts patients at risk for infections,” the release said. If granted by a federal judge, the injunction would require the company and the individual defendants to stop treating patients with unapproved stem cell products until, “among other things,” they obtain necessary FDA approvals and correct their manufacturing practice violations, the release states.

In a written statement, FDA Commissioner Dr. Scott Gottlieb said, “Cellbased 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 [Wednesday], 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.”

Gottleib’s statement added that the FDA supports “sound, scientific research and regulation of cell-based regenerative medicine” and noted that the FDA has “advanced a comprehensive policy framework to promote the approval of regenerative medicine products.”

He warned the administration would 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.”

U.S. Stem Cell Inc. responded on its website by saying it would “vigorously defend” the action. It described the FDA’s action as an effort to stop the company and related parties from performing a surgical procedure using stem cells from fat tissue “even when a physician and patent agree that such a procedure is in the best interest of the patient.” The company “believes that the patient and physician have the right to decide whether or not to use a patient’s own stem cells for a therapeutic purpose without federal government interference.”

In a separate written statement emailed to the Sun Sentinel, Comella said: “My entire career has been dedicated to studying and developing treatments utilizing the body’s own natural ability to heal, and I am devoted to helping others achieve optimal health through therapeutic procedures. It is my life’s work to pioneer regenerative medicine and educate the public about its healing potential. I remain steadfast that no government agency should deprive individuals of their right to harness the cells that exist in their body.”