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21:18 GMT
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)
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KUNA 120018 Oct 10NNNN