FDA Approves Embryonic Stem Cells for Use in Study of Spinal Cord Injury

The U.S. Food and Drug Administration (FDA) has said yes to a small safety trial of nervous-system stem cells in people with recently sustained injuries to the middle (thoracic) part of the spinal cord, the biopharmaceutical company Geron Corporation of Menlo Park, Calif., announced Jan. 23, 2009.

Although this trial has no immediate implications for people with other diseases of the nervous system, such as amyotrophic lateral sclerosis (ALS) or spinal muscular atrophy (SMA), it's seen as a major step toward developing stem-cell treatments for such conditions.

In a news release Geron said it will move forward with the "world's first study of human embryonic stem cell-based therapy in man." Although the primary goal of the study is to test safety, the investigators will also test for any functional improvement as a result of the treatment.

The cells used by Geron were derived from a single early-stage embryo a decade ago. They are treated in the laboratory to become an immature form of the cells that produce myelin, a coating that surrounds nerve fibers and is needed for their normal function, and they'll be tested in this trial for their ability to repair damaged nerves in the spine of people injured seven to 14 days prior to treatment.

Although the myelin-producing cells to be used in the Geron trial are probably not the cells that might ultimately be tested in ALS, they and the processes used to produce them are similar to those under development for this disease.

"Embryonic stem cell treatments have been widely praised for their potential application in the repair and restoration of disease or injury damaged tissues and organs," said Chris Airriess, chief operating officer at California Stem Cell (CSC) in Irvine, Calif., where he has MDA support to develop stem cell-based therapies for ALS. "This huge milestone reached by Geron is a watershed in the development of the field of regenerative medicine."

CSC Scientific Advisory Board Chairman Hans Keirstead and member Gabriel Nistor are co-inventors of Geron's experimental treatment for spinal cord injury.

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