Hope—and anxiety—run high as the first clinical trial of embryonic-stem-cell therapy begins this
Six weeks before the hoopla over President Barack Obama's executive order lifting restrictions on embryonic-stem-cell research, Hans Keirstead, a scientist at the University of California, Irvine, was already sipping champagne. In 2005 Keirstead had published a study showing that a therapy derived from human embryonic stem cells could make partially paralyzed rats walk. Now he'd gotten word that the FDA had cleared the way for Geron, a small biotech company in California, to launch the first clinical trial of the treatment in human beings with spinal-cord injuries. It was incredible news,not just for Keirstead, who'd been wanting to invent a therapy for brain and spinal-cord disorders since he was 11 years old, but for scientists who believe human embryonic stem cells can teach them about complex diseases and potentially lead to cures. Keirstead, 41, and his team of scientists hailed the news over a case of chilled Veuve Clicquot. "We put the last bottle down about six hours later," Keirstead says. "It was just a really fun time."
Opinions about the moral status of an embryo won't change with presidential decrees or FDA decisions, so you can bet that the debate over embryonic-stem-cell research is far from over. But no matter how loud the chatter gets, the science is about to leave the Petri dish. For years, academic researchers have felt stymied by limitations imposed by George W. Bush that allowed federal funding only for research on 21 embryonic-stem-cell lines that already existed. Scientists who wanted to pursue newer cells had to find private dollars, some of which came from state initiatives. Geron, meanwhile, had its own money and was doggedly pursuing its mission to get human embryonic-stem-cell treatments into people. This summer, the company plans to enroll the first of up to 10 patients in a clinical trial that everyone—clinicians, scientists, biotechs, patients, ethicists—will be watching. There is plenty of excitement from people with spinal-cord injuries and their physicians, who can offer little hope for any significant improvement right now. But some scientists are concerned that the research may not be ready for prime time. The simple truth: even if all goes perfectly in the early stage of the trial, which tests for safety, no one with a spinal-cord injury is going to be cured any time soon. Peter Kiernan, chairman of the Christopher and Dana Reeve Foundation, says he is constantly balancing hope against hype among patients. "I feel like I'm in a car turning the steering wheel at the same time that I'm pushing on the brakes."
