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Advanced Cell Technology Inc. (ACT) today released data from a U.S. clinical trial testing the safety of treating Stargardt’s macular dystrophy (SMD) with human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) cells. The news comes one day after the Marlborough company announced that it had started using its hESC on an SMD patient in a Phase 1/2 trial in Europe.
The results of the Phase 1/2 clinical trial, which began in the U.S. in July 2011 and just started in Europe on Monday, showed no safety issues for two patients who underwent clinical treatment at UCLA’s Jules Stein Eye Institute, ACT said in a news release today. The two patients had “measurable improvements” in vision last longer than four months, the company also noted.
The trial, which focused on studying the safety of the transplant, did not indicate any signs of rejection, ectopic tissue formation, hyperproliferation or tumor formation. ACT is testing the use of hESC-derived RPE cells in patients with SMD, as well as those with dry age-related macular degeneration (AMD).
The results of the trial were published in The Lancet.
In October, MIT professor and serial entrepreneur Robert Langer joined the board of directors at ACT, where he also now chairs the board’s scientific advisory committee.
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