Stem cell treatments have promised regenerative cures for many untreatable conditions since the first successful stem cell transplant back in 1956. In the world of eyecare, where damaged retinal tissue results in permanent and uncorrectable vision loss, the prospect of recovering vision with a stem cell therapy is an understandably exciting one. Much excitement surrounded the successful Phase I/II clinical study of injecting stem cells into the eye to treat conditions like Stargardt macular dystrophy and macular degeneration in February 2015. Of the 18 patients treated with stem cell injections in that study, there were no significant adverse events and 47% of eyes showed either improvement or no worsening in vision over a 2 year period. But unfortunately these early successes in the field of ocular stem cell injections have led some to take risky approaches to gain financially from the excitement around stem cell treatments and the desperation of patients that are faced with living with permanent vision loss.
The possibilities of stem cell therapy in eyecare are very exciting, but these cases show that we have much to learn about how to utilize stem cells safely in ocular tissue. If you or a loved one are considering stem cell treatment, look carefully for these red flags before taking on the risk of permanent blindness.
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| Pluripotent stem cells from the California Institute for Regenerative Medicine which is currently doing FDA approved stem cell research for retinitis pigmentosa. |
In September 2017, a report was published in OSLI Retina of a 77 year old woman blinded after receiving stem cell injections in both her eyes to treat macular degeneration. Despite years of treatment for wet macular degeneration, this patient's vision was limited to 20/400 in the right eye and 20/200 in the left eye due to the severity of her disease. She reached out to a clinic in Georgia that reported doing new stem cell treatments for macular degeneration, where she thought she was enrolling in a clinical study. She paid $8,900 for the treatment, money she raised on a crowd funding website. On the day of treatment she was injected with stem cells in both eyes. A little over a month later she presented back to her usual doctors at the Florida Retina Institute with retinal detachment in the left eye, and then another 2 months later the right eye also detached. Despite multiple surgeries to try to repair the tissue, she suffered devastating vision loss. Her sight is now reduced to hand motion in the right eye and no light perception (unable to see anything at all - just total darkness) in the left eye, and she is no longer able to walk on her own.
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| The patient's eyes after retinal detachment repair via |
What's even worse? This has happened before. In March, major news networks picked up the report of 3 women blinded after similar stem cell injections in Florida published in the New England Journal of Medicine. Like the Georgia case, these women had macular degeneration, had paid $5000 to be treated, were injected in both eyes on the same day, and thought they were participating in a clinical trial. In this instance, the study center in question was actually listed on ClinicalTrials.gov, but the National Health Institute released a statement after this report that the Clinical Trials website is open to anyone in the medical community to post a study, and the listing of a study center is not an endorsement that the FDA is supervising or involved in the study. Since that time the rules for posting a study have been updated.
With over 570 clinics advertising stem cell treatments directly to patients online, the lack of oversight by the FDA and the confusion that exists as to the safety of these treatments poses a major risk. How can you spot a potentially dangerous treatment?
- Are you being asked to pay out of pocket? Federally funded clinical trials will not require you to pay to participate! Paying thousands of dollars out of pocket is a red flag that you are not in fact participating in a clinical trial.
- Are you receiving treatment at an accredited ocular treatment center? The safest place to have any experimental treatment is at a center known for participating in clinical trials. Especially for ocular treatments where the risk is so great, make sure that you are being seen by an eye doctor specifically. If something were to go wrong, like retinal detachment, you'll need to be in a facility that is equipped to take you immediately into ocular surgery. Ask if there is an ocular surgeon on site to treat complications like retinal detachment if you are at a private facility and aren't sure. If the answer is no, it is a big red flag.
- Are you being treated in both eyes at the same time? Never, never, never should an experimental procedure be conducted on both eyes at once. Only the worst seeing eye should be treated in a clinical study of a high risk treatment, and that eye should be observed for improvements or complications for a period of months before treating the other eye would be considered.
- Is the treatment specifically approved by the FDA or under a clinical investigation that has been approved by the FDA? Stem cell therapy is regulated by the FDA, so require that you see paperwork confirming you are in a FDA regulated and approved clinical trial. You can learn more about how to spot a scam on the FDA's website.
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| In March 2017, a study out of Japan reported a man received the first of its kind stem cell transplant treatment for macular degeneration. One year after treatment his vision is stable with no improvement or worsening from baseline. via |
The possibilities of stem cell therapy in eyecare are very exciting, but these cases show that we have much to learn about how to utilize stem cells safely in ocular tissue. If you or a loved one are considering stem cell treatment, look carefully for these red flags before taking on the risk of permanent blindness.
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