ACT Seeks FDA Approval For Stem Cell Study
Advanced Cell Technology Inc. of Marlborough has filed an application with the U.S. Food and Drug Administration seeking permission to begin the first phases of studies into a stem cell-based treatment for macular degeneration, an eye disorder that can cause blindness.
The company said macular degeneration represents a $25-billion to $30-billion market opportunity and that there are currently no FDA-approved treatments for the most common, "dry" form of macular degeneration.
In its studies, ACT will transplant retinal pigment epithelial cells derived from human embryonic stem cells into patients with dry age-related macular degeneration.
The company has already received approval from the FDA for a similar process for treating juvenile macular degeneration.
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