2013 Advanced Cell Technology’s clinical partner, the University of California, Los Angeles (UCLA), has received FDA approval of its Investigator Investigational New Drug (IND) application, providing a green light for UCLA scientists to commence a phase I/II study using ACT’s retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) to treat myopic macular degeneration (myopia), or nearsightedness.
Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA’s Jules Stein Eye Institute, will initiate the 12-patient study to evaluate the safety in patients with severe myopia, which can lead to permanent vision loss.
“We are encouraged by Dr. Schwartz’s keen interest in the evaluation of ACT’s RPE cells in potentially treating myopia,” Gary Rabin, chairman and CEO of ACT stated in the press release. “We are pleased to be on track to broaden the scope of our RPE program with the initiation of the new Investigator IND. Nearsightedness is a very common condition, worldwide, and it is estimated that roughly 30 percent of cases are high, or severe, myopia.”
Dr. Schwartz is also the principal investigator in each of ACTC’s two phase I/II clinical trials for Stargardt’s macular dystrophy and dry age-related macular degeneration (dry AMD). He echoed the global need for the treatment for myopia.
“We look forward to initiating the clinical trial,” Dr. Schwartz stated. “Myopic degeneration is an increasingly important global cause of permanent central vision loss for which there is no accepted treatment. Applying our key learnings from the ongoing ACT-sponsored stem cell trials allows the research promise of regenerative medicine to include myopic vision loss.”
The myopia clinical trial is designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with myopia at 12 months, the study’s primary endpoint.
For more information, visit www.advancedcell.com
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