Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC or the “Company”), a leader in the field of regenerative medicine, today announced treatment of the fifth and sixth patients in the company’s European clinical trial for Stargardt’s Macular Dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs), completing the second patient cohort. The patients were injected with 100,000 hESC-derived RPE cells, as compared to 50,000 cells in the first cohort. The outpatient transplantation surgeries were performed successfully and the patients are recovering uneventfully.
“Having completed the second, higher-dose patient cohort in all three of our clinical trials in the U.S. and Europe, we are now officially at the halfway point in all three, which we find very gratifying,” commented Gary Rabin, chairman and CEO of ACT. “We have been able to add new trials sites and consequently to quicken the pace of patient enrollment in our ongoing trials. We feel this should also serve to hasten the pace at which we are able to complete the second half of the trials.”
The E.U. clinical trial is one of the three trials being carried out by the company in the U.S. and Europe. Each trial will enroll a total of 12 patients, with cohorts of three patients in an ascending dosage format. 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. Preliminary results from the two U.S. trials were reported in The Lancet earlier this year.
“Completing the higher-cell dosage in all three of our trials is a significant milestone in our RPE program,” said Robert Lanza, M.D., ACT’s chief scientific officer. “At our current pace of patient treatments, we should be on track to complete all three trials in 2013.”