Retinal Research Institute: New FDA-Approved Stem Cell Research Study
- Posted on: Feb 19 2018
Information for Patients with Geographic Atrophy Related to Dry Age-Related Macular Degeneration – An Experimental Treatment of Severe Vision Loss from Advanced Dry Age-Related Macular Degeneration.
What is the Investigational treatment?
This investigational treatment includes using an implant to replace some of the cells in the retina that have been lost or damaged due to Dry AMD. The implant is a small patch with a single layer of cells on a thin membrane which will be surgically inserted between the layers of your retina.
Where do the cells come from?
The RPE cells were produced from human embryonic stem cells which were derived from a single embryo that was intended to be discarded but eventually donated for medical research. These stem cells have been thoroughly tested and approved for such use. The cells are put on a very small membrane to make the implant.
**size of implant compared to one U.S cent coin
Who can participate?
Females and Males diagnosed with advanced Dry Age-related Macular Degeneration
• Ages 55-85 years
• Severe vision loss due to Dry AMD in at least one of the eyes
• Willing to have a surgical procedure to replace damaged and lost cells in the retina • Willing to undergo diagnostic testing after surgery to monitor the response of the retina.
• Willing to undergo diagnostic testing after surgery to monitor the response of the retina
What is involved in participation?
You will undergo the procedure under general anesthesia, in the hospital for day surgery. The study involves multiple visits to your retina physician for assessments, before and after the procedure, for up to five years after surgery. You will be transported from your home for the visits or be compensated for travel costs.
What will happen during the surgical procedure?
• A vitreoretinal surgeon will perform a standard small-gauge vitrectomy. This is a very common retinal surgery.
• A space will be created between the retinal layers where your lost or damaged cells were located.
• The implant is surgically inserted between the layers of your retina. The small implant has a thin layer of retinal pigment epithelial (RPE) cells. The same type of cells that have been damaged or lost in your eye.