Three women have were left nearly blind or totally blind after receiving an unproven medical procedure at a for-profit stem cell clinic in Florida.
According to CBS News, the treatment method used on the women has not been proven effective and has not undergone testing to determine whether the treatment is safe for humans. The treatment involved injecting a cell preparation derived from each of the patient’s own fat tissue into both of the patient’s eyes.
Ophthalmologists who examined the women following their treatments said all the women had fairly functional vision before the procedure and that all the women were totally or legally blinded within a day of receiving the treatment.
Ophthalmologists determined that the women had all suffered detached retinas in both eyes and that the women’s vision is not expected to improve.
Reports state that the three women, all in their 70s and 80s, were seeking treatment for age-related macular degeneration – a leading causes of vision loss in individuals over the age of 50. The women were charged $5,000 for the unproven treatment.
Two of the women stated they had decided to go to the clinic because it listed a macular degeneration study on a federal data base overseen by the National Institutes of Health called ClinicalTrials.gov; however, the clinic removed the study before any patients were recruited to participate.
By the time the women had opted to undergo the treatment, consent forms listed the treatment as a medical procedure and not a clinical study.
One of the ophthalmologists who observed the women stated that many stem cell clinics allege that they are not subject to FDA regulations. As such, he urges patients to receive written documentation that a treatment has been registered with the FDA and that patients should always make sure they are being treated by a licensed physician.