Geron Gets FDA Nod To For Groundbreaking Stem-Cell Study

The US Food and Drug Administration has approved the world’s first human test of a treatment made from embryonic stem cells This study of patients with spinal cord injuries was and still is very controversial. The study has been on hold for almost a year because of safety concerns.

Alan Trouson, president of the California Institute of Regenerative Medicine, was quoted as saying, “This is an important milestone for the whole field,” “We are looking with hope and expectation that the transplant will be safe and effective.”

Dr. Richard Fessler, a neurological surgeon at Northwestern Universitity will lead the study. He said, If Geron’s treatment works, it “would be revolutionary,” and added, “The therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year.” Fessler is not financially connected to the Geron company that is based in Menlo Park.

More than $150 million dollars and fifteen years was spent by Geron on developing a stem-cell treatment that can be injected into people that have severe spinal cord injuries in order to restore their motor functions. Fessler added, and “getting it into a clinical trial, just by itself, is a big deal,”