Advanced Cell Technology, Inc. (ACTC) Receives Data and Safety Monitoring Board Authorization to Proceed with Patient Enrollment
Advanced Cell Technology, a leading player in the field of regenerative medicine, today announced it is now authorized to proceed with enrollment and treatment of additional patients in its clinical trial for dry age-related macular degeneration (dry AMD).
The authorization, issued by the Data and Safety Monitoring Board (DSMB), allows ACT to continue patient screening and enrollment for the second cohort, who 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.
ACT says the DSMB clearance marks a key achievement for the company’s RPE program. The trial of topic is designed to determine the safety and tolerability of hESC-derived RPE cells used after sub-retinal transplantation into patients with dry AMD at 12 months.
“DSMB authorization to move to the higher dosage of cells in our clinical trial for dry AMD represents a significant milestone for our clinical programs,” Gary Rabin, chairman and CEO of ACT stated in the press release. “Our RPE program is now advancing rapidly, as we are now screening at multiple ophthalmological centers for the fourth surgery in both our dry AMD trial and our U.S. SMD trial, with our EU SMD trial, which was initiated much later, not far behind.”
ACT is conducting three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration, each of which will enroll 12 patients, with cohorts of three patients each in an ascending dosage format.
For more information visit www.advancedcell.com
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