First Embryonic Stem-Cell Trial Gets Approval From the FDA

by Dave Keating | January 23, 2009 at 05:37 am

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The Food and Drug Administration (FDA) in the United States has approved the first trial for Embryonic Stem-Cell-derived medical treatment. The medicinal trial is being undertaken by Geron Corp. of California.

The announcement comes quickly on the heels of President Obama's reversal of the anti-stem cell research policies of the Bush administration.

While campaigning for the presidency Obama was clear that he was a supporter of stem cell research and pledged to double funding to research programs that use embryonic cell science to find cures for ailments like cancer, osteoporosis, ALS and Parkinson's Disease.

The Geron embryonic stem cell study will involve 10 subjects and is the first embryonic research ever conducted on humans, not just in the United States but in the world.

To find out more about the study parameters and the Geron embryonic stem cell research program visit the corporate website.

In a watershed moment for one of the most contentious areas of science and American politics, the U.S. Food and Drug Administration cleared the way for the first-ever human trial of a medical treatment derived from embryonic stem cells.

Geron Corp., a Menlo Park, Calif., biotechnology company, is expected to announce Friday that it received a green light from the agency to mount a study of its stem-cell treatment for spinal cord injuries in up to 10 patients. The announcement caps more than a decade of advances in the company's labs and comes on the cusp of a widely expected shift in U.S. policy toward support of embryonic stem-cell research after years of official opposition.

"This is the dawn of a new era in medical therapeutics," said Thomas B. Okarma, Geron's president and chief executive officer. The hope that stem-cell therapy will repair and regenerate diseased organs and tissue "goes beyond what pills and scalpels can ever do."