A California specialist in stem cell cures for spinal cord injuries and his financial backer are lobbying to test his novel techniques on humans without necessarily having trials on primates. Although normally new therapies are tested on larger animals such as dogs and monkeys before using them on humans, Hans Keirstead, of the Reeve-Irvine Research Center, maintains that spinal trauma victims must be helped as soon as possible. “Are we going to learn anything from the monkey studies?” he asks. “If so, then yes, we should do them. If not, then it’s a waste of time and a delay for getting into humans.”
Thomas Okarma, the CEO of Geron, a publicly-traded stem-cell company which has funded Keirstead’s work, also dismisses the need for trials on large animals. He wants a clinical trial to begin in mid- 2006. Ultimately, the decision to begin clinical trials rests with the Federal Government’s Food and Drug Administration, whose responsibility is to decide whether the potential benefits outweigh the risks.
Keirstead’s impatience is not shared by all embryonic stem cell researchers. Evan Snyder, of the Burnham Institute, in La Jolla, is also working on spinal cord injury but is happier to go more slowly. He fears that premature testing on humans could set back the cause of ESC research if patients were injured or died. Conservatives would then use the setback to quash research programs. He feels that spinal cord injury is too complicated to be the subject of the first trials and that an early target should be something like Lou Gehrig’s disease.
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