Three patients at a Florida clinic went blind after receiving eye injections of stem cells derived from their own abdominal fat, according to a report Thursday in The New England Journal of Medicine.
The experimental stem cell treatment was advertised in a listing at ClinicalTrials.gov, a government-run web site, which lent it an air of legitimacy and drew patients from far and wide. But the treatments were being sponsored by a for-profit company, and patients were being charged $5,000 each, according to the report.
The authors said these case reports show the need for heightened public protection in stem cell treatments. While previous warnings about private, for-profit stem cell treatments have involved lack of efficacy, they write, "(O)ur case reports establish the possibility of devastating outcomes from such procedures."
The authors include physicians from Bascom Palmer Eye Institute, the University of Miami and The Center for Sight in Sarasota.
The patients who underwent the treatments were in the early stages of age-related macular degeneration, the most common cause of blindness, the article said.
The government web site identified the company that sponsored the treatments as U.S. Stem Cell Inc., formerly known as Bioheart Inc. The clinic where they took place is U.S. Stem Cell Clinic LLC in Sunrise, which is in Broward County.
On its web site the clinic advertises stem cell treatments for a host of common ailments such as osteoarthritis, diabetes, lung disease and heart failure. It does not advertise eye treatments. The clinic also advertises stem-cell treatments for severe and life-threatening problems such as ALS and Parkinson's, as well as brain injuries and paralysis.
While the journal article does not name the blinded patients, apparently one was Elizabeth Noble of Kansas City, Mo. She has a lawsuit pending against the company in Broward Circuit Court.
The lawsuit names the company, the clinic, nurse practitioner Alejandro Perez and ophthalmologist Shareen Greenbaum of Hollywood Eye Institute.
Kaiser Health News reported that insurers for Greenbaum, U.S. Stem Cell and the nurse paid out more than $3 million in 2016 to patients harmed by stem cell procedures, although it is not clear if those patients are the same ones detailed in the study.
U.S. Stem Cell said in a statement Wednesday that it could not comment on these cases but that it has “successfully conducted more than 7,000 stem cell procedures with less than 0.01% adverse reactions” since 2001. The Kaiser report says Greenbaum did not return calls for comment.
The listing at ClinicalTrials.gov said the Institutional Review Board -- the group that is supposed to protect patients enrolled in clinical trials -- for the eye study was the International Cellular Medicine Society. Health News Florida has requested information by phone and e-mail from the society, based in Las Vegas, on how it performed its oversight of the eye study at the Sunrise clinic.
More in-depth information about stemcell therapies is at the NPR health blog Upshots.