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.