FDA Seeks to Shut Down Two Stem Cell Clinics Tied to Dangerous AMD Treatments

June 1, 2018: By Jon Swedien

The FDA filed two complaints in federal court seeking permanent injunctions against two stem cell clinics, the agency announced May 9.

An agency news release said the complaints seek to stop the clinics—US Stem Cell Clinic LLC (Florida) and California Stem Cell Treatment Center Inc—from marketing stem cell products without agency approval and for significant deviations from current good manufacturing practice requirements.

“Cell-based 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,” FDA Commissioner Scott Gottlieb said in a news release announcing the complaints.

US Stem Cell Clinic said in a statement that it would “vigorously defend a lawsuit” and argued that patients and physicians have the right to decide to use a patient’s own cells for a therapeutic purpose without government interference.

During an inspection of US Stem Cell Clinic in April and May 2017, FDA investigators documented evidence of significant deviations from current good manufacturing practices in the manufacture of at least 256 lots of stem cell products, the FDA said.

The agency also inspected California Stem Cell Treatment Center’s Beverly Hills and Rancho Mirage facilities in July 2017. Investigators documented, among other violations, evidence of significant deviations from current good manufacturing practice requirements, including failing 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, the FDA said.

Ajay E. Kuriyan, MD, MS, a retinal fellow at the Bascom Palmer Eye Institute, and other researchers studied three patients who received $5 thousand treatments at US Stem Cell Clinic and suffered “blinding visual outcomes.” The New England Journal of Medicine published the study.

One of the patients, a 72-year-old woman, suffered from vision loss, pain, and vomiting, according to the study. The two other patients—a 78-year-old woman and an 88-year-old woman—both suffered a retinal detachment, among other complications, the study found.

The study found that the women’s visual loss after the injection was associated with ocular hypertension, hemorrhagic retinopathy, vitreous hemorrhage, combined traction, and rhegmatogenous retinal detachment, or lens dislocation. After one year, the patients’ visual acuity ranged from 20/200 to no light perception, the study said.

While numerous research institutions are investigating stem-cell therapies, many stem-cell clinics are treating patients with little oversight and with no proof of efficacy, and these are often funded by patients at nonacademic centers, the study said.

The study also said the patients paid for a procedure that had not been studied in a clinical trial, lacked sufficient safety data, and was performed in both eyes on the same day. The study noted that experimental bilateral intravitreal injections “are both atypical and unsafe.”

Two of the patients in the study said they thought they were participating in a clinical trial, and they had found the clinic by searching clinicaltrials.gov.

The patients, however, signed consent forms that did not mention a clinical trial, the study said.

The FDA is also targeting US Stem Cell Clinic’s chief scientific officer, Kristin Comella, and its co-owner and managing officer, Theodore Gradel, as individuals in one complaint. In the other it is targeting California Stem Cell Treatment Center’s Elliot B. Lander, MD, and Mark Berman, MD, as individuals.

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