Last year, a 77-year-old woman traveled to a clinic in Georgia to have stem cells injected in her eyes.
The procedure was supposed to work like this: The clinic would take fat from her belly, separate out stem cells that naturally occur in fat, and inject them into her eyes to regenerate damaged tissue.
In March, eye doctors based primarily at the Bascom Palmer Eye Institute in Miami had published a widely covered report describing three eerily similar cases: Three elderly women with macular degeneration got stem cells derived from their own fat injected into their eyes at a different stem-cell clinic in Florida.
Perhaps the stem cells had differentiated into cells that formed a membrane and then contracted, peeling the retina away from the rest of the eye. Or perhaps there was scarring caused by immune cells, which are part of the mix of cells in fat that can be injected along with stem cells into the eye.
The agency says stem cells do not have to be regulated as drugs as long as clinics follow certain standards, like if they only minimally manipulate the cells and don’t change their purpose in the body.
If stem cells are being separated from fat and then injected to treat a disease, then the FDA may have reason to step in.