According to the company, the clearance enables it to move forward with the world’s first study of a human embryonic stem cell (hESC)-based therapy in man.
Geron plans to initiate a Phase I multi-center trial that is designed to establish the safety of GRNOPC1 in patients with complete American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries.
Thomas Okarma, Geron’s president and CEO, said: “The FDA’s clearance of our GRNOPC1 investigational new drug is one of Geron’s most significant accomplishments to date. The ultimate goal for the use of GRNOPC1 is to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient’s injured spinal cord.”