Federal regulators have cleared the way for the first human trials of human embryonic stem-cell research, authorizing researchers to test whether the cells are safe to use in spinal injury patients, the company behind the trials announced Friday. The tests could begin by summer, said Dr. Thomas Okarma, president and CEO of the Geron Corporation. The Food and Drug Administration has approved the trials, which will use human stem cells authorized for research by then-President George W. Bush in 2001.
The patients will be those with the most severe spinal cord injuries, called complete spinal cord injuries. Geron has a licensing agreement with the Wisconsin Alumni Research Foundation for use of its stem-cell lines.