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Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today 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 two additional patients with dry age-related macular degeneration (dry AMD). ACT will screen and enroll the second and third patients of the three-patient second cohort in the trial. Per trial protocol, each patient will be injected with 100,000 human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells.
“Dry AMD represents one of the largest unmet medical needs in the world, and we are thrilled to be making steady progress in our clinical trial for this condition,” commented Gary Rabin, ACT’s chairman and CEO. “We are well on our way to the halfway point of all three of our clinical trials. We also
recently secured DSMB approval to complete the second cohort of our two trials for Stargardt’s Macular Dystrophy.”
ACT is conducting three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration, dry AMD and Stargardt’s Macular Dystrophy (SMD). Each trial will enroll a total of 12 patients, with cohorts of three patients each in an ascending dosage format, from 50,000 to 200,000 hESC-derived RPE cells. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD or SMD at 12 months, the study’s primary endpoint.
“This authorization to treat the next two patients in the second, higher-dosage cohort of our trial for dry AMD represents a notable milestone for our clinical programs,” commented Robert Lanza, M.D., ACT’s chief scientific officer. “We look forward to treating these two patients and moving on to the third cohort in good time.”