FDA Greenlights Geron to Begin First Human Trials of Embryonic Stem Cell Treatment

(July 30) -- The Food and Drug Administration has cleared biotech firm Geron to perform the first human trials of a medical treatment based on embryonic stem cells.

Patients with recently sustained spinal cord injuries will be the first to undergo the company's stem cell therapy, called GRNOPC1. The trial was initially approved by the FDA in January 2009 but stalled shortly after due to safety concerns.

Embryonic stem cells have been a focus of medical research in recent years because of their ability to be differentiated into any kind of cell. In this case, they'll be turned into precursors of neural support cells and then injected into damaged spinal cords.

Ideally, the cells will repair key nerve cells and enable them to function again normally.

For now, however, Geron's trial is strictly phase one. That means the study will test only the safety of the procedure rather than its effectiveness.

And the trial is also extremely small. Eight to 10 patients, all of whom sustained a spinal cord injury within seven to 14 days, will undergo treatment.

Of course, the procedure has already been tested extensively in animals. Geron is also evaluating GRNOPC1 to treat ailments of the nervous system, like Alzheimer's disease and multiple sclerosis.

Whether GRNOPC1 works or not, the science on which it's founded is not without controversy. The stem cells used are sourced from leftover embryos at fertility clinics. To some, those embryos qualify as human lives.