An unproven stem cell treatment advertised as a clinical trial has caused three women to become permanently blind. The New England Journal of Medicine explained that using stem cells derived from adipose tissue has recently become a more frequent treatment for a multitude of disorders in stem cell clinics in the United States. The three women were searching for a treatment for macular degeneration and believed this could be the cure. The study was listed on a clinical database run by the National Institute of Health called ClinicalTrials.gov. Jeffrey Goldberg, a professor of ophthalmology at the Stanford University School of Medicine, noted that it is especially concerning that the stem cell clinic was able to post the study on such a database. He said this is “an opportunity for the FDA to increase patient safety for these unapproved clinical trials.” One of the patients actually believed she was taking part in a government-sanctioned study. This raises the issue of whether the government is doing enough to protect the people from the dangers of unapproved trials and treatments.
Stem cell treatments can cause many complications, including detached retinas, hemorrhages, hypertension and vision loss. Thomas Albini, a University of Miami ophthalmologist, called this treatment a “disaster.” While the patients only had mild vision loss before treatment, after undergoing this treatment they lost most of their vision, if not all of it. He suggested that contamination during the preparation of the stem cell treatment could be responsible for the vision loss. Another possibility is that the stem cells could differentiate into the type of cells associated with scarring. Albini pointed out that “even if the solution had been prepared correctly, there is no evidence that it could have helped restore the patients’ vision.” He warned, “Buyer beware: these stem-cell clinics that function in this very unregulated way are doing procedures that are not approved… and they can be quite dangerous.” The particular clinic in South Florida that treated the three women who lost their vision continues to perform other stem-cell studies such as studies of degenerative disc disease and chronic obstructive pulmonary disease.
The clinic’s chief scientific officer, Kristen Comella, said that after two patients suffered from detached retinas after treatment, the clinic stopped performing this eye procedure. These two patients sued the clinic and some of the researchers because of the harmful results of the treatment. Andrew Yaffa, their attorney, reported, “The case was resolved to the mutual satisfaction of the parties.” Though these two people were compensated for their injuries, unsafe and unapproved treatments continue to be offered and administered. Paul Knoepfler, a stem cell scientist at the University of California at Davis, compared the practice of offering unapproved treatments at stem cell clinics to advertising products that are not FDA approved. He called this practice “puzzling and concerning” and stressed that it can be extremely problematic and dangerous.