WASHINGTON (Reuters) – U.S. doctors have begun treating the first patient to receive human embryonic stem cells, but details of the landmark clinical trial are being kept confidential, Geron Corp said on Monday.The license for this trial was issued to Geron by the FDA just three days after newly inaugurated President Barack Obama took office.
Geron has the first U.S. Food and Drug Administration license to use the controversial cells to treat people, in this case patients with new spinal cord injuries. It is the first publicly known use of human embryonic stem cells in people.
MENLO PARK, Calif., January 23, 2009 - Geron Corporation (Nasdaq: GERN) announced today that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury.The trial was halted in August of last year by the FDA, but it now once again has the go-ahead and going ahead it is. Human embryonic stem cells, when they are not a subject of political football with the extreme political right, hold great promise. Because embryonic stem cell shave the potential to develop into any cells into the body, it holds the promise to cure chronic illnesses and injuries. The Roman Reed Spinal Cord Injury Research Act of 1999 in California provided the initial funding to Geron's work with embryonic stem cells. It is that work that is now going to human trial. Roman Reed's father and also the sponsor of the Roman Reed Act, Don Reed, issued the following statement upon hearing this news:
[T]he law named after my son, the Roman Reed Spinal Cord Injury Research Act of 1999 provided initial funding for Dr. Hans Keirstead's work with embryonic stem cells to remyelinate injured axons. This work, after many years of dedicated effort by Geron, is now in human trials at last.Don Reed is a much respected former colleague of mine, and he blogs on the issues focused on stem cell research at Stem Cell Battles. I encourage everyone interested in this issue to keep up with Mr. Reed's blog. He is one of the best and most respected advocates on behalf of embryonic stem cell research not only in California but also in the United States.
While we know the initial study will be low-dose safety trials, everyone in the paralysis community hopes for the best.
This is the beginning of something wonderful: a new day, when wheelchairs are for temportary occupancy only.
This is great and exciting news, folks. This one's for all those who fight for science, for cures, and for human advancement.