Many of my AMD patients keep asking me what new medical treatments are there for AMD, specifically in the area of stem cell treatment.
As many of you may have heard in the news, a recent case report was published in The New England Journal of Medicine which highlighted three cases in which AMD patients became legally blind after undergoing an injection of adipose-tissue-derived stem cells at a private stem cell clinic (1).
While stem cell research is still controversial, the most shocking thing about this report was that all three patients had functional vision, one eye even with 20/40, before the procedure and presented with complications within days to one week after the procedure. In contrast, another report in the same issue which showed success in safety in one patient, injected with skin cell-derived stem cells, showing results one year later without any visual improvement but no vision loss (2).
As I am sure most of you know, our patients with AMD or any type of vision loss are in fear of going blind and have much anxiety over their condition. We have all experienced a low vision patient coming into our office who has been to every other eye doctor in town looking for that “Magic Pair of Glasses” or treatment that will improve their vision.
When it comes to stem cell treatment and the poor results of the case reported above here’s what we need to know. There are registered trials using stem cells to treat AMD. Most currently have only shown success in safety. While one trial of 18 patients with AMD and Stargardt’s, did show an increased acuity in some, they questioned the reliability of the patient’s responses (3). They also reported no adverse events in 72%.
So what occurred with the three patients reported last month who lost vision?
Currently, there are many Stem Cell Clinics popping up all over the world, including the US, that are offering stem cell treatment with without any regulation, oversight and are based on unproven treatments. Patient’s signing up for these treatments may be under the impression that these trials are based on sound scientific evidence and are FDA approved.
The patients who lost vision were injected with cells that had no scientific evidence of working and paid $5,000 for the treatment. The authors also note that patients were injected bilaterally, which is atypical for an experimental procedure and unsafe. They speculate that the patient’s vision loss could have resulted from the toxic effects of the materials injected, poor stem cell preparations and or stem cell transformation into the wrong type of cell.
So what should we tell our patients?
- Most stem cell trials are showing promise in regards to safety, but more work needs to be done.
- Clinical trials can be found at www.clinicaltrials.gov, but this only shows that the trial is registered and does not indicate safety, or oversight.
- True clinical trials should not require any form of payment and are based on scientific evidence.
- Ajay E. Kuriyan, M.D., et al, Vision Loss after Intravitreal Injection of Autologous “Stem Cells” for AMD. N Engl J Med 2017; 376:1047-1053
- Mandai, M, Autologous Induced Stem-Cell-Derived Retinal Cells for Macula Degeneration. N Engl J Med. 2017 Mar 16;376(11):1038-1046
- Schwartz SD, et al, Subretinal Transplantation of Embryonic Stem Cell-Derived Retinal Pigment Epithelium for the Treatment of Macula Degeneration: An Assessment at 4 Years. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(5)