Print“The field of regenerative medicine is poised to take embryonic stem cell therapies from the realm of nebulous potential to that of tangible and real treatments that will make a significant difference in the lives of millions of people worldwide.”
Advanced Cell Technology has won the second-ever U.S. Food and Drug Administration clearance for a human embryonic stem cell-derived therapy in humans, allowing the company to proceed with plans to study the safety of its experimental treatment for Stargardt’s Macular Dystrophy, a rare children’s eye disease.
The approval represents a glimmer of progress in the slow-moving acceptance of such trials at the FDA, which has waded through concerns over the potential for embryonic stem cells to cause tumors, fights over the morality of destroying embryos, and an ongoing battle over federally funded embryonic stem cell research.
In July, Menlo Park, California’s Geron became the first company to secure the agency’s allowance for testing a human embryonic stem cell-based therapy. That enabled Geron to initiate an early-stage study of GRNOPC1, its treatment for acute spinal cord injury patients. Now ACT too is free of the administrative holds the agency had used to temporarily block the studies.
“With the initiation of this clinical trial, and that of Geron's earlier this fall, the field of regenerative medicine is poised to take embryonic stem cell therapies from the realm of nebulous potential to that of tangible and real treatments that will make a significant difference in the lives of millions of people worldwide,” says Bill Caldwell, ACT’s chairman and CEO.
Twelve patients will be enrolled in ACT’s study at sites in California, Oregon, Massachusetts, and New Jersey. It’s a small trial, focused primarily on safety. But ACT hopes that with other studies, it will ultimately help the company develop the insights necessary to conquer other kinds of eye diseases with larger potential markets. Taken together, the company says that degenerative diseases of the retina affect as many as thirty million people in the United States and Europe, offering a $25 billion to $30 billion market that has yet to be effectively addressed.
November 24, 2010
http://www.burrillreport.com/article-stem_cell_trial_gets_fda_go_ahead.html
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