Advanced Cell Technology, a biotech company focused on the field of regenerative medicine, today announced it has treated the final patient in the first patient group participating in its phase 1/2 clinical trial for Stargardt's macular dystrophy (SMD), which causes progressive vision loss and eventual blindness. The trial uses retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) as treatment for SMD.
The outpatient transplant surgery was performed July 27 at Moorfields Eye Hospital in London without any complications. This is the tenth patient overall to now be treated with Advanced Cell's RPE cell therapy. The phase 1/2 trial, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with SMD, will involve a total of 12 patients, with cohorts of three patients each in an ascending dosage format.
Gary Rabin, Advanced Cell chairman and CEO, said the company anticipates receiving clearance to initiate the treatment of the second patient cohort in the coming weeks.
"This is a significant month for the company," Rabin stated in the press release. "One year ago we treated the first of our patients in our two U.S. clinical trials. The one-year follow-up for those initial patients indicates that the improvements in visual acuity we initially reported have in fact persisted now for a year. Indeed, we are consistently observing improvements in subjective and objective visual acuity for patients being treated at the various clinical centers involved in our trials. Again, these trials are still at very early stages, but these preliminary results indicate that we are on the right track."
The European Medicines Agency's (NYSEMKT:EMA) Committee for Orphan Medicinal Products (COMP) has officially designated Advanced Cell's hESC-derived RPE cells as an orphan medicinal product for the treatment of SMD.
For more information visit advancedcell.com
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