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Third patient cohort begins stem cell treatment for AMD in phase I study

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Advanced Cell Technology Inc. announced that the third patient cohort is being treated in each of its two U.S. clinical trials for age-related macular degeneration, according to an ACT press release.

Initiated in July 2011, the two phase I trials are designed to determine the safety and tolerability of hESC-derived retinal pigment epithelial (RPE) cells following subretinal transplantation in patients with Stargardt’s macular dystrophy (SMD) and dry AMD at 12 months, the studies’ primary endpoint, according to the release.

Both trials will involve 16 patients, with cohorts of three patients each in an ascending dosage format, and four patients with better vision, receiving 100,000 hESC-derived RPE cells.

“We have now treated 20 patients,” Robert Lanza, MD, chief scientific officer, said in the release. “We are encouraged by the steady progress of our U.S. clinical trials and are eagerly anticipating initiating treatment of the third patient cohort in our European trial, as well.”

Further information about the trials is available at www.clinicaltrials.gov, with the following identifiers: NCT01345006 (U.S. SMD), NCT01344993 (dry AMD), and NCT01469832 (E.U. SMD), the release said.