WASHINGTON — Federal regulators have approved the first experiment testing human embryonic stem cells on people, officials announced Friday.
The Food and Drug Administration authorized the Geron Corp. of Menlo Park, Calif., to test stem cells derived from human embryos on eight to 10 patients with severe spinal-cord injuries.
The study is aimed primarily at determining the safety of the cells in human subjects, but researchers also will examine the patients for any signs that the therapy restored sensation or movement.
“This is obviously an extraordinarily exciting event,” Geron chief executive Thomas B. Okarma said in a statement. “It marks the dawn of a new era in medical therapeutics . . . one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of health replacement cells.”
Although researchers have already begun testing embryonic cells derived from adults and fetuses in people, the study will mark the first government-approved use of those derived from embryos, which have been highly controversial because the process involves the destruction of the embryos.
President Barack Obama is expected to lift a ban on federal funding for such research imposed by his predecessor. (Geron’s work had not been restricted by the ban; the cells being used were derived from leftover embryos at fertility clinics before the ban was implemented in 2001.)
The approval of Geron’s project, however, has been eagerly awaited by embryonic stem-cell research backers. The FDA had delayed approval of Geron’s application in May, saying the agency needed more information.
“This is what we’ve all been waiting for,” said Robert Lanza of Advanced Cell Technology in Worcester, Mass., which plans to ask the FDA to approve another study using embryonic stem cells to treat blindness. “The field desperately needs a big clinical success.”
