FDA Gives Geron Approval for Stem Cells Trial Treatment |
Within the next two months, a clinical trial of a treatment based on embryonic stem cells in patients with acute spinal cord injury is set to begin. This will be the world’s first trial of this kind of treatment.
Geron, a Californian biotech company, had their trial put on “clinical hold” by the FDA because of safety concerns that were raised after the results of one of the animal studies. The FDA will now allow the trial to proceed without any delay, after further testing on rats addressed the concerns.
Embryonic stem cells have great potential to be used in “regenerative medicine,” because they have the ability to become any human tissue. But they carry the ability to create ethical and political controversy because of their origin from human embryos. This controversy has severely restricted their use, especially in the US.
Geron’s product, known as GRNOPC1 consists of immature nerve cells grown from stem cells. The cells with be injected into the spinal cord of accident victims, with the belief that they will partially repair the damaged nerves and restore some movement to human patients, as it did when injected into animals with spinal injuries. In the future, Geron is also exploring using GRNOPC1 to grow nerve cells in degenerative nervous system diseases such as multiple sclerosis.