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Next phase of Stargardt's macular dystrophy trial under way
Treatment of a second patient cohort has begun in a U.S. clinical trial for Stargardt’s macular dystrophy, according to a press release from Advanced Cell Technology. This trial involves the injection of double the number of human embryonic stem cell-derived retinal pigment epithelium cells as the first cohort.
On July 11, the first patient from the second cohort was injected with 100,000 RPE cells derived from human embryonic stem cells, the release said. The successful outpatient procedure was performed by a team led by Carl D. Regillo, MD, FACS, OSN Retina/Vitreous Board Member, at Wills Eye Institute.
The phase 1/2 trial, initiated in July 2011, is examining the safety and efficacy of the cells in Stargardt’s macular dystrophy patients, according to the release. It will include four cohorts of three subjects each, with each cohort receiving a higher dosage. Advanced Cell Technology is conducting a concurrent Stargardt’s macular dystrophy trial in the United Kingdom.
“Doubling the cell dosage marks an important milestone in our clinical programs,” Robert Lanza, MD, Advanced Cell Technology’s chief scientific officer, said in the release. “We look forward to continued progress and safety findings in the coming months, in both our U.S. and European trials.”