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Thursday, Mar 16 2017

Full Issue

Dangers Of Unregulated Stem Cell Treatments Highlighted After Three Women Lost Sight

Stem cell clinics are flourishing, but the government has not done much to protect patients from the sometimes risky treatments.

Three women suffered severe, permanent eye damage after stem cells were injected into their eyes, in an unproven treatment at a loosely regulated clinic in Florida, doctors reported in an article published Wednesday in The New England Journal of Medicine. One, 72, went completely blind from the injections, and the others, 78 and 88, lost much of their eyesight. Before the procedure, all had some visual impairment but could see well enough to drive. (Grady, 3/15)

Scientists have long studied the use of stem cells, including those taken from a patient鈥檚 own body, for treating vision problems and a variety of other diseases. But they and regulators have also issued warnings about clinics that offer unproven stem cell therapies. (Ritter, 3/15)

"One of the big mysteries about this particular case and the mushrooming stem cell clinic industry more generally is why the FDA has chosen to effectively sit itself out on the sidelines even as this situation overall grows increasingly risky to patients," says Paul Knoepfler, a University of California, Davis, stem cell researcher who has studied the proliferation of stem cell clinics. "The inaction by the FDA not only puts many patients at serious risk from unproven stem cell offerings, but also it undermines the agency's credibility," Knoepfler wrote in an email. (Stein, 3/15)

In the current climate, consumer stem cell clinics have flourished. There are roughly a dozen in the Bay Area, where they鈥檙e flanked by the locations of some of the nation鈥檚 most prominent stem cell scientists, UCSF and Stanford. But the work that鈥檚 coming out of academic institutions is usually vastly different from what鈥檚 on offer at the clinics, which typically lack federal approval for the treatments they offer, stem cell experts said. And though California hasn鈥檛 seen cases of stem cell therapies gone horribly awry in a consumer clinic, it may just be a matter of time. (Allday, 3/15)

Hundreds of stem cell clinics have sprung up across the nation offering therapies. But many of these medical interventions have not been vetted through federal protocols for safety and effectiveness. Because stem cells are harvested from the patient who will receive the treatment, many of these clinicians say they do not need the Food and Drug Administration鈥檚 approval, said Karen Maschke, a research scholar at the Hastings Center, a bioethics research institute. (Heredia Rodriguez, 3/15)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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