The Federal Drug Administration has approved the first human clinical trial of a therapy using embryonic stem cells. Beginning this summer, Geron, a biotech company in Menlo Park, California, will work with a handful of medical centers to inject neural stem cells into eight to 10 patients who have recently suffered an acute spinal cord injury—paraplegics who can still control their arms but are no longer able to walk. "For us, it 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," Dr. Thomas Okarma, Geron's president and chief executive officer, said in a teleconference.
The phase-one study will focus on the safety of the treatment, but researchers say they will also keep an eye out for signs that the therapy works to restore spinal cord function; previous studies with rats suggest that the treatment is safe and that the stem cells will repair damaged neurons and release a substance that will help nerves function and grow. Since the cells need to be injected within two weeks of the injury, before any scar tissue forms, the patients for the trial have not yet been chosen.
Geron says the embryonic stem cell line used for the treatment is one of the oldest, so the research was eligible for federal funding under Bush administration regulations (which restricted eligible stem cell lines to those created before an August 2001 executive order), though the company did not use any federal money to develop the treatment or fund the study. This week, Barack Obama is expected to end the restrictions and expand support for research on embryonic stem cells (while ensuring "that all research on stem cells is conducted ethically and with rigorous oversight," he says).
A number of other companies are currently developing embryonic stem cell therapies, and if the trial proves safe, expanded trials that focus on the efficacy of the treatment could soon be on the horizon. —Heather Wax