Associated Press
A U.S. biotech company says it plans to start this summer the world's first study of a treatment based on human embryonic stem cells—a long-awaited project aimed at spinal cord injury.
The company gained federal permission this week to inject eight to ten patients with cells derived from embryonic cells, said Thomas Okarma, president and CEO of Geron Corp. of Menlo Park, California.
The patients will be paraplegics, who can use their arms but can't walk. They will receive a single injection within two weeks of their injury.
The study is aimed at testing the safety of the procedure, but doctors will also look for signs of improvement like return of sensation or movement in the legs, Okarma said.
Continuing Controversy
Whatever its outcome, the study will mark a new chapter in the contentious history of embryonic stem cell research in the United States—a field where debate spilled out of the laboratory long ago and into national politics.
(Read "The Stem Cell Divide" from National Geographic magazine.)
While some overseas doctors claim to use human embryonic stem cells in their clinics, stem cell experts said they knew of no previous human studies that use such cells.
"It's a milestone and it's a breakthrough for the field" because Geron passed the safety hurdles for getting federal clearance to launch the study, said Ed Baetge, chief scientific officer of Novocell Inc. His company hopes to begin a similar human study for treating diabetes in a few years.
In addition, said spinal cord injury researcher Wise Young of Rutgers University, "a lot of hope of the spinal cord injury community is riding on this trial."
(Related: "Stem Cells Repair Damaged Spinal Cords in Mice" [September 20, 2005].)
High Potential
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