US begins first human embryonic stem cell trial

AFP/File – A researcher manipulates drops of stem cells in a laboratory.

 

WASHINGTON (AFP) – US doctors have begun the first tests of human embryonic stem cells in patients, treating a man with spinal cord injuries in a landmark trial of the controversial process, the Geron Corporation said Monday.

The patient began the pioneering treatment Friday with an injection of the biotech company's human embryonic stem cells, as part of a clinical trial that aims to test safety and efficacy toward regaining sensation and movement.

The treatment took place at the Shepherd Center in Atlanta, Georgia, a spokeswoman for the hospital told AFP, declining to give further details due to patient privacy concerns.

The Phase I trial is expected to involve around 10 patients. Participants in the human trials must be severely injured and start treatment with Geron's product, GRNOPC1, seven to 14 days after sustaining their injury.

Patients will be given a single injection of two million of Geron's GRNOPC1 cells in the trial.

Those taking part will be followed up for one year to monitor safety and also to see if they have regained any sensory function or movement in their lower extremities.

If the initial group of subjects shows no negative side-effects, Geron plans to seek FDA approval to extend the study to increase the dose of GRNOPC1 and to include patients with "as broad a range of severe spinal cord-injured patients as medically appropriate."