The first study on embryonic stem cell treatment of spinal patients approved
Geron, a Menlo Park biotechechnology company, announced that federal regulators allow to proceed the first in the world human test of embryonic stem cell treatment for the patients with injuries of spinal cord that was postponed for almost a year due to the safety reasons.
Dr. Richard Fessler from Northwestern University said that if the treatment worked it would be very promising. As a neurological surgeon, he will lead the research on developing stem cell treatment for patients with spinal injuries to help restoring their motor function. He believes that the therapy they work on will help numerous patients suffering severe injuries of spinal cord.
In 2009, the Food and Drug Administration put this research on hold because a few animals the company used for testing treatment had developed small cysts. The similar cysts appeared in animal studies before, but in Geron's research they seemed to appear more frequently.
The officials of FDA avoided commenting on why they approved the study lately. Geron however reported that cysts had not lead to any further consequences to animals and the company had changed some procedures what allowed to minimize the possibility of cysts formation.
Several years ago Geron's studies showed that the spinal treatment helped paralyzed rats walk. The treatment includes changing of embryonic stem cells into another cell types that help nerve fibers to regain myelin which is often stripped away during injures.
However, no test has been so far run on people. Apart from ethical concerns regarding using embryos as a source of cells, some researches were afraid that injections of embryonic stem cells into people might lead to teratomas formation.
Approval of Geron's studies is a turning point in embryonic stem cell treatment research. Dr. Robert Lanza, Geron's chief scientific officer, said they were hoping to start their clinical trials during the following few months. He noted that it's not important who would start the first clinical trials of the treatment but rather if the therapy would help the spinal patients.