First Human Clinical Trial of Embryonic Stem Cell Therapy …

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October 11, 2010|3:06 pm

The first-ever clinical trial of human embryonic stem cell-based therapy on a human patient is now underway, according to the first and presently only company in the United States with the license to use the controversial cells to treat people.

The Calif.-based Geron Corporation announced Monday the enrollment of the first patient in its clinical trial at the Shepherd Center in Atlanta, where the biopharmaceuticals company hopes to see the first major breakthrough for human embryonic stem cell research.

"Initiating the clinical trial is a milestone for the field of human embryonic stem cell-based therapies," commented Dr. Thomas B. Okarma, Geron's president and CEO.

We look forward to participating in clinical trials that may help people with spinal cord injury," added Dr. Donald Peck Leslie, medical director of the Shepherd Center, a 132-bed spinal cord and brain injury rehabilitation hospital and clinical research center.

Less than three months ago, the U.S. Food and Drug Administration gave Geron approval to proceed with its trial on a therapy for patients with spinal-cord injury. The trial involves injecting a stem-cell treatment into patients with severe spinal cord injury with the hope that it will help damaged nerve cells regrow and eventually allow patients to regain movement.

The FDA had originally approved the study in January 2009 and the trial was scheduled to begin last summer. But Geron found that animals used in a preclinical study had developed small cysts that appeared with a higher frequency than other studies, resulting in an FDA hold on the trial.

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Despite the latest green light, opponents and even some proponents of embryonic stem cell research raised concern about the clinical trial.

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First Human Clinical Trial of Embryonic Stem Cell Therapy ...