This month researchers at the National Eye Institute announced that they will begin clinical trials to test the safety of a new stem cell therapy that could be used in order to treat geographic atrophy. For those of you who have never heard of geographic atrophy before it is a chronic disease that results in vision loss and is sometimes referred to as dry macular degeneration. It is the leading cause of vision loss for people that are aged 65 or older and there is no FDA approved treatment for it.
A Brief Overview of Geographic Atrophy
It is currently estimated that 1 million people in the United States suffer from Geographic Atrophy, and an estimated 5 million people around the world suffer from it. Even though it is one of the leading causes of vision loss the actual causation of the disease is not entirely understood. What is known is that an individual’s chances for getting Geographic Atrophy increases exponentially as they get older and that the disease causes progressive and irreversible damage to the retina.
Current non-stem cell-related treatments that are being researched are hoping to halt the progression of retinal damage and the National Eye Institutes trial is seeking to do the same thing. The disease destroys cells in the eye called retinal pigment epithelial cells and as these cells die the corresponding photoreceptors in the eye die as well. If this occurs and is not halted it could eventually result in blindness.
What Does the NEI Hope to Achieve?
The NEI’s clinical trials will take an individual’s blood cells and then turn those cells into iPS cells. While all of this sounds very technical, essentially an iPS cell can be turned into any type of cell in the body. The NEI will program the iPS cells to become retinal pigment epithelial cells, therefore, replacing the dying RPE cells and ensuring the health of the photoreceptors. This in turn essentially keeps the disease at bay. If this works it would potentially save millions of Americans from vision loss and if the disease was caught early enough it could effectively prevent vision loss altogether.
This particular treatment has already been shown to work in animals but there are some concerns with moving to a human trial. With any stem cell treatment there is always the worry that the cells will begin to multiply uncontrollably and in turn, form a tumor and although this did not happen in the animal trials there is always fear that this could occur in human patients.
The clinical trial will consist of 12 patients who have advanced stage Geographic Atrophy and they will be given the RPE implants and then monitored for a year to see how they respond. The trial will also be looking to confirm the safety of the stem cells. One of the things that the NEI will be looking for in particular is whether or not they can establish good manufacturing practices in order to scale up the operation while also maintaining a good product. This was part of what the FDA wanted to see in order to allow the clinical trial to begin and it will be a good indicator of the long-term viability of the tests.
It will be interesting to see the outcome and we will be watching these trials closely as they offer hope to millions of people around the world who are currently losing their eyesight.
Need More Information on Stem Cell Therapy?
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