First ever study of human stem cell treatment
The FDA says yes to the world's first study in man of a human embryonic stem cell based therapy to treat spinal injury.
Geron plans to initiate a Phase I multi-center trial, designed to establish the safety of GRNOPC1 in patients with subacute thoracic spinal cord injuries. The study will be conducted in up to seven U.S. medical centers.
"This marks the beginning of what is potentially a new chapter in medical therapeutics - one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells. The ultimate goal 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." says Thomas B. Okarma, Geron's president and CEO, in a press statement