Advanced Cell Technology Inc. today announced the completion of the second patient cohort of 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).
The conclusive fifth and sixth patients were injected with 100,000 hESC-derived RPE cells, as compared to 50,000 cells in the first cohort; the company reports that both 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,” Gary Rabin, chairman and CEO of Advanced Cell stated in the press release. “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 European clinical trial is one of the three trials being carried out by the company in the U.S. and Europe, and represents an important achievement in the company’s progress.
“Completing the higher-cell dosage in all three of our trials is a significant milestone in our RPE program,” said Robert Lanza, M.D., Advanced Cell chief scientific officer. “At our current pace of patient treatments, we should be on track to complete all three trials in 2013.”
Each of the three trials 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.
For more information, visit www.advancedcell.com
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