First Ever Human Stem Cell Trials Begin

The Food and Drug Administration has tapped a Northern Californian biotech company to do the first human clinical trial using embryonic stem cells.

Geron, located in Menlo Park, Calif. had applied for FDA approval last March.

Researchers plan on injecting stem cells into the spines of patients who recently suffered a devastating spinal cord injury.

This will be a phase-one study looking at safety measures, but researchers say said they will be looking for signs as to whether therapy is working.
Seven medical centers have been selected to participate in the trial, buy the hospitals must first have the study approved by their internal review boards.

Geron officials said there is no evidence the change in administration led to the approval of their study.

"When we run the course of trials, hopefully the cell therapy will able to restore movement, perhaps organ function or just sensory function for the person at the site of the injury," said Geron Chief Financial Officer David Greenwood.

The stem cell line used in the study is one of the oldest, so it was eligible for funding under the Bush Administration's policy.

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