FDA seeks permanent injunctions against two stem cell clinics
The FDA recently filed two complaints in federal court seeking permanent injunctions against two stem cell clinics to stop them from marketing stem cell products without FDA approval, according to a press release.
The FDA is seeking a permanent injunction against US Stem Cell Clinic LLC of Sunrise, Florida, its 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 violating current good manufacturing practice requirements. The clinic did not address violations in a warning letter previously sent by the FDA.
In response, US Stem Cell Clinic released a statement on its website announcing it would “vigorously defend a lawsuit” filed by the U.S. Department of Justice at the request of the FDA, citing the right of a patient and physician to decide whether or not to use a patient’s own cells for a therapeutic purpose without government interference.
The FDA is also seeking a permanent injunction against California Stem Cell Treatment Center Inc., with locations in Ranch Mirage and Beverly Hills, California, and Elliot B. Lander, MD, and Mark Berman, MD, to stop them from marketing stem cell products to patients without FDA approval, according to the release.
At the 2016 American Society of Retina Specialists annual meeting, Ajay E. Kuriyan, MD, MS, presented the case findings of two patients treated at Bascom Palmer Eye Institute at the University of Miami after receiving stem cell treatments from US Stem Cell Clinic. Each patient underwent intravitreal injections of 0.1 cc of autologous adipose tissue-derived stem cells and paid $5,000 for the procedure. Each signed a consent form for the procedure. A third patient was treated at Dean McGee Eye Institute, according to Kuriyan.
“I am hopeful that the increased oversight and regulation of these ‘stem cell’ clinics will help protect other patients from the harm that the three patients we reported experienced,” Kuriyan told Healio.com/OSN.
One patient, a 72-year-old woman with a history of dry age-related macular degeneration, presented to Bascom Palmer 3 days after the procedure with decreased vision, pain, vomiting and nausea. On presentation, her visual acuity was only hand motion perception in both eyes, Kuriyan said.
Kuriyan warned patients to be wary of clinics who offer stem cell treatments as their only treatment and who charge patients to be treated.
“While it’s important that these ‘stem cell’ clinics are being better regulated, it’s important to distinguish them from the positive strides being made in scientifically rigorous clinical trials demonstrating the possibility that we can use stem cell therapies in the future to treat retinal diseases,” he said. – by Robert LinnehanReferences:
FDA seeks permanent injunctions against two stem cell clinics. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607257.htm. Published May 9, 2018. Accessed May 14, 2018.
Kuriyan AE, et al. Severe vision loss after intravitreal injections of autologous adipose tissue-derived stem called for age-related macular degeneration. Presented at: American Society of Retina Specialists meeting; Aug, 10-14, 2016; San Francisco.
U.S. Department of Justice files lawsuit at request of FDA to stop U.S. Stem Cell Clinic from performing autologous stem cell procedure. us-stemcell.com/doj-files-lawsuit-against-usstemcellclinic/. Published May 9, 2018. Accessed May 14, 2018.
For more information:
Ajay E. Kuriyan, MD, MS, can be reached at University of Rochester Medical Center, School of Medicine and Dentistry, 601 Elmwood Ave., Box 659, Rochester, NY 14642; email: email@example.com.
Disclosure: Kuriyan reports no relevant financial disclosures.