Blinded by science: Women go blind after stem-cell treatment at Florida clinic

Three women reportedly went blind after a stem cell treatment at a Florida clinic.

What’s more is that at least two of the women had gone to the clinic because it was listed as a macular degeneration study on a federal database.

Doctors call the incident an example of how risky such clinics can be.

News reports from The Associated Press, The New England Journal of Medicine and others say that a clinic the experimental procedure occurred was in Sunrise, Florida run by U.S. Stem Cell Inc.

Age-related macular degeneration can rob a person of their central vision.

The women were injected in their eyes with a cell preparation derived from her own fat tissue.

Ophthalmologist Dr. Thomas Albini of the University of Miami, who examined the women, said one woman is totally blind and the others legally blind.  He said all suffered detached retinas.

“These women had fairly functional vision prior to the procedure … and were blinded by the next day,” Albini said.

The clinic’s method hasn’t been proven effective or tested for safety in people, he added.

“It’s very alarming to us as clinicians that somebody would do this to both eyes at the same time,” said Albini.

 

Dr. Thomas Albini of the University of Miami.

Elizabeth Noble, one of the women said she was diagnosed with age-related macular degeneration that blurs the central vision. The former educator said she heard about the treatment at the clinic for a research study described on ClinicalTrials.gov, a website run by the National Institutes of Health.

The former educator said she heard about the treatment at the clinic for a research study described on ClinicalTrials.gov, a website run by the National Institutes of Health.

“It’s very easy to register studies on ClinicalTrials.gov and essentially use a government website as a marketing device,” Leigh Turner, a bioethicist at the University of Minnesota, told BuzzFeed News.

Noble went to the clinic in June 2015  where staff took fat from around her belly button, extracted those cells and mixed them with Noble’s blood plasma. They then injected it into both her eyes for $5,000, according to a story in Buzzfeed.

In an editorial accompanying the Journal’s report, stem cell expert Dr. George Daley, dean of Harvard Medical School, called the clinic’s treatment careless.

“This report joins a small but growing medical literature highlighting the risks of such wanton misapplication of cellular therapy,” he wrote. Providing such treatments for profit outside a proper research setting “is a gross violation of professional and possibly legal standards,” he said.

Buzzfeed reports this isn’t the first time experimental procedures at a clinic have gone awry.

In 2010, for example, a woman with the autoimmune disease lupus died after her own bone marrow cells were injected into her kidneys at a clinic in Thailand.

In 2013, the Florida Department of Health revoked the medical license of Zannos Grekos over the death of a 69-year-old woman. He had extracted material from her bone marrow, filtered it, and then infused it into the arteries feeding her brain. The woman had a stroke.

Treatment for age-related macular generation is at the center of the Medicare fraud trial in West Palm Beach of Dr. Salomon Melgen, who happens also to be tied to a bribery scandal involving a U.S. senator.

Read The Palm Beach Posts coverage of the fascinating Melgen trial by clicking here.