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“Off-the-charts dangerous”: Sham stem cell trial at Florida clinic blinds three women

I can summarize a recent press release I wrote about an unproven stem cell treatment in three words: sad, shocking and sobering.

Three women with macular degeneration — a common, degenerative cause of vision loss — heard about a so-called clinical trial run by a private clinic in Florida in 2015. The results were disastrous. As the press release states: "Within a week following the treatment, the patients experienced a variety of complications, including vision loss, detached retinas and hemorrhage. They are now blind."

A paper documenting the three cases appeared online today in The New England Journal of Medicine.

"There's a lot of hope for stem cells, and these types of clinics appeal to patients desperate for care who hope that stem cells are going to be the answer, but in this case these women participated in a clinical enterprise that was off-the-charts dangerous," said co-author Thomas Albini, MD, an ophthalmologist at the University of Miami, where two of the patients were treated for complications following the botched procedures.

The cases highlight a series of problems. First and foremost, the clinic, unnamed in the paper, posted a listing for a trial on ClinicalTrials.gov. Those listings aren't carefully screened for scientific soundness, said co-author Jeffrey Goldberg, MD, PhD, chair of ophthalmology at Stanford, and some of the patients believed they were participating in a properly designed clinical trial that was based on a sound hypothesis and substantiated with preliminary laboratory experiments.

The researchers want the case to serve as a warning to others and to call attention to the importance of regulating unproven stem cell "therapies." They point out a few red flags for patients:

  • Don't pay to participate in a clinical trial. "I'm not aware of any legitimate research, at least in ophthalmology, that is patient-funded," Albini said.
  • See if a trial is affiliated with an academic medical center — that's a good sign it is legitimate, they say.
  • Ensure that the care provider is a licensed physician with relevant clinical experience.
  • For more information, consult the website A Closer Look at Stem Cells, maintained by the International Society for Stem Cell Research.

They also emphasize that not all stem cell research is so fraught with peril. "There's a lot of very well-founded evidence for the positive potential of stem cell therapy for many human diseases," Goldberg said.

Previously: FDA audit of Texas stem cell clinic revealed by Houston Chronicle, Bioethicist Arthur Caplan slams unproven stem cell clinics and Stem cell researchers challenge clinics' questionable practices
Image by JoJan

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