The Food and Drug administration announced that they have permitted the Menlo biotech firm Geron to move ahead with the world’s first human test of a treatment made from embryonic stem cells. The study mostly involves individuals and patients that have had some sort of spinal cord injury or trauma.
The study has been on hold for many years amid safety concerns, but now it looks as if the company will be able to move ahead.
Dr. Richard Fessler, a neurological surgeon at Northwestern University said that if the treatment does what it is supposed to do, it could change the face of medicine as we know it.
The treatment allows for stem cells to be injected into the spinal cords of patients in hopes that it would help restore their motor functions that were lost as a result of their injury.
“The therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year,” noted Richard.
Geron has spent 15 years and over $150 million to develop the treatment, but has been waiting for government approval before moving ahead. They said that their first priority was to get the treatment into clinical trial, and then they would move ahead from there.
The study was originally put on hold last year after a few animals that were being used in the study developed small cysts. The company said that the cysts had shown up in previous studies, and that they had seen the appearance of the cysts happen more rapidly in recent tests. Apparently, the FDA thought that the procedure was safe to move forward with.