Human embryonic stem cell trial wins approval : Nature News In a milestone for a politically charged field, the US Food and Drug Administration (FDA) has approved the world's first clinical trial of a therapy generated by human embryonic stem cells.

Geron, a Menlo Park, California-based company, announced on 23 January that it has won the regulatory agency's approval to launch a small, phase I safety study of a stem cell“derived therapy for spinal cord injury. The publicly traded company has an extensive patent portfolio relating to embryonic stem cell research, and few other competitors; the announcement sent its shares soaring. On Friday, they closed up 36 percent, at $7.09.

In the trial, eight to ten paralyzed individuals within 7 to 14 days of their injury will be injected at the point of injury with stem cell“derived precursors to oligodendrocytes, which are key supportive cells in the central nervous system. It is hoped that the cells will lay down sheaths of myelin ” an insulator essential for conducting nerve impulses ” around injured neurons, as well as stimulating nerve cells to regenerate. The cells have demonstrated both capabilities in animals.1

The company said it expects to begin enrolment early this summer at up to seven US medical centres.

Politics and approval

In a conference call with analysts and reporters, Geron's president and CEO Thomas Okarma said that the trial "marks the dawn of a new era in medical therapeutics. This approach is one that reaches beyond pills and scalpels to achieve a new level of healing."

The news of the FDA approval came on President Barack Obama's third full day in office, prompting speculation that Geron's 22,000-page FDA application, first submitted last March, was delayed for political reasons. President Bush had placed tight restrictions on federal funding for embryonic stem cell research; President Obama has promised to reverse those. (The Geron cells come from one of a score of lines approved for federal funding under the Bush policy.)

Both the company and the FDA denied that any politics were at play. "Science drives our decision making," says Karen Riley, an FDA spokeswoman. "Political considerations have no role in this process. The timing was coincidental."