KHN: 3 patients blinded from experimental stem cell treatment
An experimental stem cell treatment blinded three patients, a report published in New England Journal of Medicine found, according to Kaiser Health News.
Here are six key notes:
1. The procedure entails providers extract cells from fat and then treat them with enzymes to extract stem cells. Providers then drew blood from the patient and obtained platelet-dense plasma. The providers mixed the cells with the plasma and injected the mixture into the patients' eyes.
2. The three patients underwent treatment in 2015 for age-related macular degeneration. Providers treated both eyes at the same time, which the report authors noted is atypical and unsafe, according to KHN.
3. Within days after the procedure, the three patients sought medical care for complications. Of the three, two suffered bleeding and all three had retinal detachments. The researchers do not expect the patients to regain their sight.
4. The report authors said clinicaltrials.gov, a database National Library of Medicine runs, advertised the trials on its site and is where two of the patients learned about the trial. However, researchers note the trial "lacked proper safeguards," according to KHN.
5. The report didn't delve into specifics regarding the clinic involved in the study or the study's sponsor. However, it did say the clinic is not performing the stem cell procedures. The clinic continues to treat patients.
6. Jeffrey Goldberg, MD, PhD, professor and ophthalmology chairman at the Byers Eye Institute at Stanford (Calif.) University and report co-author, said researchers hope to bring to light the way clinical trials are defined to the public and the possible ethics involved in this practice.
In the report, Dr. Goldberg stated, "I would emphasize it's a challenge and we can't expect patients to fully vet these options. And that's where the ethics of the doctors and oversight of regulatory agencies need to play a role in the public health of our community."
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