WASHINGTON, Oct 11 (KUNA) -- The first patient who has been paralyzed by a spinal cord injury has been treated with human embryonic stem cells, it was reported here Monday.
Geron Corporation, which is sponsoring the groundbreaking study, confirmed that the patient had millions of embryonic stem cells injected into the site of the damage.
According to the Corporation, "the primary objective of this Phase I study is to assess the safety and tolerability of GRNOPC1 in patients with complete American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries".
It indicated that participants in the study "must be newly injured and receive GRNOPC1 within 14 days of the injury".
Commenting on this, Gerons President and CEO Thomas Okarma said in a statement that "initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies".
He affirmed that "this accomplishment results from extensive research and development and a succession of inventive steps to enable production of cGMP master cell banks, scalable manufacture of differentiated cell product, and preclinical studies in vitro and in animal models of spinal cord injury, leading to concurrence by the FDA to initiate the clinical trial." (end) si.bs KUNA 120018 Oct 10NNNN