First human embryonic stem cell therapy approved
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The US Food and Drug administration (FDA) has approved the first human trials using embryonic stem cells to test a pioneering therapy for paralyzed patients, marking a shift in the nation's stem cell policy under Barack Obama's presidency.
AFP- US authorities have approved the first human trials using embryonic stem cells to test a pioneering therapy for paralyzed patients, the FDA said Friday.
"The FDA has granted its clearance for a new drug application of Geron Corp for a phase one clinical trial of an embryionic stem-cell based therapy in patients with acute spinal cord injury," FDA spokeswoman Susan Cruzan told AFP.
Earlier, the US biotech firm Geron Corp. announced it had been cleared to carry out the human trials, testing the therapy on patients paralyzed by spinal-cord injury.
In a press release, the Menlo Park, California firm said the US Food and Drug Administration (FDA) had cleared it for the first phase of trials of a novel therapy called GRNOPC1.
Embryonic stem cells are highly versatile, primitive cells capable of developing into any tissue of the body.
The goal is to inject cells into the spines of paralyzed volunteers in the hope that this will prompt damaged nerve cells to regrow, enabling the patients to eventually recover feeling and movement.
"The clearance enables Geron to move forward with the world's first study of a human embryonic stem cell based therapy in man," Geron said.
All federally-funded research on new lines of embryonic stem cells was banned under the previous administration of president George W. Bush.
President Barack Obama said before Tuesday's inauguration that he hopes Congress will introduce legislation to overturn the ban.
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