A new report shows that one Florida stem cell clinic was responsible for blinding three elderly patients. These three female patients were told they were participating in a study on age-related macular degeneration (AMD) stem cell treatments. As this new report shows, they all went blind just a day after the clinic gave them stem cell injections.
Thomas Albini, an ophthalmologist at the University of Miami, told reporters that all of these women had functional vision before visiting the clinic. Only one day later, all of these women were either partially or completely blind.
This new report, published in the New England Journal of Medicine, said that each of these women paid $5,000 for the corrective AMD injection in 2015. These women were in their 70s or 80s at the time.
The stem cell clinic, located in the city of Sunrise, is officially owned by US Stem Cell, Inc. Two of the women said they found out about this clinic on an official federal website.
All three of the women described the procedure they went through in detail to reporters. Apparently, the doctors working at this clinic developed a stem cell preparation from the patients' fat tissue. This preparation was injected directly into both of their eyes in one sitting.
Unfortunately, Dr. Albini doesn't believe these women will ever regain their vision. One woman has been declared totally blind, while the other two are legally blind. Dr. Albini noted that all three of the patients had detached retinas.
The clinic listed this eye procedure as a part of a "study" on the website ClinicalTrials.gov. However, the consent form these women were asked to sign was only for a medical procedure, not an FDA-approved study. Dr. Albini said anyone using ClinicalTrials.gov should take the listings there with a grain of salt.
Two of the women blinded by this clinic have pursued legal action. Although both cases have been resolved, the women's attorney declined to comment on the details of the cases.
This stem cell clinic is still operational in Sunshine, but it no longer performs eye-related stem cell therapies. Company officials declined to comment on the specific case of these women. People who work for this clinic only said that they've conducted "7,000 stem cell procedures with less than 0.01 percent adverse reactions."
Dr. George Daley, the dean of the Harvard Medical School, wrote an editorial in response to the New England Journal of Medicine's report. Dr. Daley criticized this and other stem cell clinic's recklessness. He said that what the Sunshine clinic did was a "gross violation of professional and…legal standards."
Although patients should be careful when applying for stem cell tests, Dr. Daley says people shouldn't write off stem cell research when they hear of cases like this. For example, Dr. Daley wrote about how Japanese researchers were recently able to cure a woman's eye disease by taking cells from her skin to create eye tissue. Dr. Daley said this Japanese case proves how stem cell research can successfully treat eye diseases if done with diligence, patience, and care.
Anyone is interested in applying for a stem cell study in the US should get written documentation from the FDA to prove the study is legitimate.