ACT Secures Approval to Proceed with Increased RPE Dosage for Patients in Clinical Trial for Dry AMD
July 12, 2012
Advanced Cell Technology, Inc. (OTCBB: ACTC) announced earlier this week that the Data and Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the company’s three ongoing clinical trials, has authorized the company to move forward with enrollment and treatment of additional patients in its clinical trial for dry age-related macular degeneration (dry AMD). ACT will proceed with patient screening and enrollment for the second cohort, who, in keeping with trial protocol, will be injected with 100,000 retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs), as compared with the 50,000-cell dose used in the first cohort.
The trial is a prospective, open-label study, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD at 12 months.
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And, the first patient was treated with the higher dose for Stargardt’s disease on Wednesday, July 9th, at Wills Hospital in Philadelphia.
Also, although not yet announced by the company, Bascom Palmer in Miami has become the third site for Advanced Cell Technology’s SMD clinical trials. Bascom is also a trial site for its dry AMD clinical trial.
