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06/09/2009 - News

FDA Approves First Embyronic Stem Cell Trial

By: June Chen, MD

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Embryonic stem cell research has been a controversial topic in both the clinical research and political arenas. You may remember that, in 2001, then-President George W. Bush imposed restrictions on stem cell research to already-existing cell lines.

Embryonic stem cell research has been a controversial topic in both the clinical research and political arenas. You may remember that, in 2001, then-President George W. Bush imposed restrictions on stem cell research to already-existing cell lines. Last week, the US Food and Drug Administration (FDA) approved the first human trial of a medical therapy that is derived from embryonic stem cells .

The FDA granted Geron Corporation, a biotechnology company in Menlo Park, Calif., approval to proceed with its study of a stem-cell treatment for complete spinal cord injuries, spinal cord injuries that result in some form of complete paralysis. The approved trials will involve 8 to 10 patients, and the tests will use stem cells that were harvested from embryos left over in fertility clinics, which would otherwise have been discarded.

The primary focus of the approved study will be the safety of stem cell treatment in humans. However, the scientists of Geron will also be monitoring the study participants for at least one year to see if they regain any function.

Source

Adapted from The Wall Street Journal, January 23, 2009 page A12.

Created on: 01/26/2009
Reviewed on: 06/09/2009

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