ACT Partner Gets Clinical Trial Approval
Marlborough-based Advanced Cell Technology Inc. said its clinical partner, the University of California – Los Angeles (UCLA), has received U.S. Food and Drug Administration approval to perform clinical trials using ACT's retinal pigment epithelial (RPC) cells, which are derived from human embryonic stem cells, to treat nearsightedness.
In a statement, ACT said the primary focus of the Phase I and II study will be to evaluate the safety of the cells in patients who have severe myopic macular degeneration, or myopia, commonly known as nearsightedness.
The study will be led by Dr. Steven Schwartz, professor of ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute. Schwartz is also principal investigator in each of ACT's two Phase I/II clinical trials for Stargardt's macular dystrophy and dry age-related macular degeneration using RPE cells derived from stem cells.
ACT said the trial will consist of 12 patients with cohorts of three patients receiving ascending dosages, and patients will be studied for one year.
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