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International

Injunction against clinic that blinded patients

02/07/2018
The US FDA has sought a permanent injunction against a stem cell clinic that left three of its patients blind, in an attempt to prevent it from marketing stem cell products without regulatory approval.

The FDA also accused the clinic of significant deviations from current good manufacturing practice requirements when it filed the complaint in federal court, after the management of US Stem Cell Clinic failed to address violations outlined in a warning letter previously sent to the clinic. Another clinic, California Stem Cell Treatment Center, was also targeted in the complaints.

“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 Dr Scott Gottlieb said in a statement.


"We cannot allow unproven products that exploit the hope of patients and their loved ones."
Scott Gottlieb, FDA Commissioner

“In some instances, patients have suffered serious and permanent harm after receiving these unapproved products. In the two cases filed today, 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.”

According to a presentation at the 2016 American Society of Retina Specialists annual meeting, two patients of the Florida-based US Stem Cell Clinic who underwent intravitreal injections of 0.1cc of autologous adipose tissue-derived stem cells reported adverse effects, included significantly reduced visual acuity in the days after the US$5,000 (AU$6,770) treatment.

One of the patients, a 72-year-old woman with a history of atrophic age-related macular degeneration (AMD) attended Bascom Palmer Eye Institute three days after the procedure with decreased vision, pain, vomiting and nausea.

According to medical news site Healio, the retinal specialist who initially treated the woman, Dr Ajay Kuriyan, said that on presentation, her visual acuity was limited to hand motion perception in both eyes.

Healio also reported that US Stem Cell Clinic released a statement announcing it would “vigorously defend a lawsuit” filed by the U.S. Department of Justice at the request of the FDA, by 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.

Image courtesy: Science Medical NN Corp.



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