First Human Embryonic Stem Cell Therapy Trial Given Approval

4 August 2010 (Last Updated August 4th, 2010 18:30)

The US Food and Drug Administration (FDA) has approved a Phase I clinical trial of Geron's GRNOPC1 drug in patients with acute spinal cord injuries. This trial will be the world's first clinical trial of a human embryonic stem cell (hESC)-based therapy in humans. It will i

The US Food and Drug Administration (FDA) has approved a Phase I clinical trial of Geron's GRNOPC1 drug in patients with acute spinal cord injuries.

This trial will be the world's first clinical trial of a human embryonic stem cell (hESC)-based therapy in humans.

It will involve patients with complete American Spinal Injury Association Impairment Scale grade A subacute thoracic spinal cord injuries. The primary endpoint will assess safety. Secondary endpoints will assess efficacy, which includes improved neuromuscular control in the trunk or lower extremities.

GRNOPC1 contains hESC-derived oligodendrocyte progenitor cells, which have demonstrated remyelinating and nerve growth stimulating properties in animals with spinal cord injuries.