Geron's on-again, off-again human trial of an embryonic stem cell therapy--a world first--is off-again. The company says the FDA ordered a halt before the first patient could be enrolled, making its move after reviewing dose escalation data from animal studies.
Joseph Pantginis, an analyst with the Merriman Curhan Ford Group in New York, says that the agency's decision to delay the trial was probably the result of safety concerns. "They are at the forefront, which a lot of times is a bit of a curse," he said. "They have to hit all the hurdles and be the first one to learn about how these cells behave."
It's also the second time that the FDA has delayed the trial. The FDA lifted an eight-month hold order in January. Geron officials were keeping their lips tight on the latest action, saying only that they are working closely with the FDA. Researchers are planning to inject nerve cells developed from ESCs into the spines of eight to 10 paralyzed patients in an attempt to restore an ability to move. And the entire ESC field is closely watching Geron's progress.