Just a month after Geron Corporation started treating people with its embryonic stem (ES) cell-based therapy, GRNOPC1, US regulators have given the green light to a second company to begin trials using human ES cells.
Advanced Cell Technology (ACT) announced today that the US Food and Drug Administration approved the Santa Monica, California-based company’s application to use retinal cells derived from ES cells to treat people suffering from Stargardt’s Macular Dystrophy, a common form of progressive juvenile blindness. The phase 1/2 trial will involve 12 patients at several hospitals across the US, including the Casey Eye Institute in Portland, Oregon, and the UMass Memorial Medical Center in Worcester, Massachusetts.
According to Robert Lanza, ACT’s chief scientific officer, the company also plans to file an investigational new drug application in the coming weeks to use the same ES cell-derived retinal cells to treat people with macular degeneration.
Stargardt’s macular dystrophy affects around 25,000 people in the US, and occurs in approximately one in 10,000 children. By comparison, macular degeneration impairs the sight of more than 10 million Americans.
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