Stem Cell Therapy Approved

Special Report - January 5, 2011

A U.S. biotech company announced January 3 that it has procured permission from the U.S. Food and Drug Administration to begin a second round of human trials for a new vision therapy it has developed using human embryonic stem cells (hESCs). The approval is Advanced Cell Technology’s (ACT) second from the FDA for a therapy derived from hESCs. The FDA first cleared the company in November to begin trials on patients with Stargardt’s disease, which is a progressive form of juvenile vision loss. This newest approval by the FDA is for a second round of human trials to treat blindness in older people known as Dry Age-Related Macular Degeneration, which is the most common cause of blindness among people over age 55. Currently, there is no cure for the disease. ACT’s proposed treatment derives cells from hESCs and then replaces the lost cells in the patient’s eyes to offset macular degeneration. ACT is the first company to receive FDA approval for two trials using human ESCs. In a press release, the company indicated plans to move forward with trials for both therapies “as quickly as possible.”

Related resources:

NIH Expands Embryonic Stem Cell Research - July 8, 2009
President Okays Embryonic Stem Cell Research - March 10, 2009
Adult Stem Cells Yield More Promise - September 12, 2008
Lawmakers Wrestle Over Stem Cell Research - May 12, 2008
Adult Stem Cells Provide Medical Breakthrough - March 5, 2008
New Adult Stem Cells Found in Bone Marrow - January 18, 2007
Hype v. Hope - Findings - March 2007
Adult vs. Embryonic Stem Cell Research - FNC - Mar/Apr 2007
An Ethical Alternative - FNC- Mar/Apr 2007
Scientists Discover New Stem Cell Methods - August 23, 2005.
Stem Cells and Human Cloning - Interview - October 2005 Part 1 - Part 2
The Alternative to Embryos - Findings - January 2005

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