Three elderly women treated for eye disease at a clinic in south Florida suffered severe and permanent damage to their vision after having stem cells injected into their eyes.
Physicians who treated the women's eye injuries after the procedures documented the situation in a journal article published Wednesday in The New England Journal of Medicine and covered by The New York Times.
Here are seven things to know.
1. The women, who were 72, 78 and 88 years old, suffered from macular degeneration, an eye disease that causes vision loss. Prior to the treatments, all three could see well enough to drive, according to the Times.
2. All three experienced detached retinas after the experimental procedure. Physicians who later examined the women believed the injected stem cells had grown into the retina and then contracted, thus pulling the retina off the eyeball. The injuries left the 72-year-old completely blinded, while the 78-year-old and 88-year-old permanently lost a significant portion of their eyesight.
3. The stem cell injections were administered at a private clinic in Sunrise, Fla., which was part of U.S. Stem Cell, a company formerly known as Bioheart. Each woman paid $5,000 a piece for the injections.
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4. The stem cells injected into the women's eyes were isolated from fat extracted from the same women's bellies via liposuction.
5. Kristin C. Comella, the chief science officer of U.S. Stem Cell, told the Times the clinic did not require approval from the Food and Drug Administration to conduct the procedures because the women were being treated with their own cells. Ms. Comella said the clinic no longer treats eye conditions.
6. All three women came to the clinic after seeing the treatment listed by U.S. Stem Cell on clinicaltrials.gov. Two of the women later told physicians they believed they were participating in research sanctioned by the government.
7. Thomas Albini, MD, an author of the NEJM article who treated two of the patients' injuries at the Bascom Palmer Eye Institute at the University of Miami Miller School of Medicine, told the Times his team alerted the FDA about the issue. While Dr. Albini said an investigator was sent to the clinic, the Times could not confirm with an FDA spokesperson if such an investigation was conducted.
"The really horrible thing about this is that you would never, nobody practicing good medicine would ever do an experimental procedure on a patient on both eyes on the same day," Dr. Albini told the Times.
To read the complete report in The New York Times, click here.
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