Geron, a California-based biotech company, plans to begin human testing soon for the first-ever embryonic stem cell therapy. The company has been working for the last ten years to develop a treatment for spinal cord injury, submitting a 22,500-page application last year to the Food and Drug Administration. Approval of this application is the final step before clinical trials can begin.
Clinical trials generally occur in three phases (I, II, and III) and are designed to carefully evaluate safety, dose, how well the drug works, and how well it compares to current therapies. The entire process can take more than a decade (and tens of millions of dollars) to complete. The National Institutes of Health has awebsite that explains the process in detail, including a list of active clinical trials.
As the Chicago Tribune article points out, much is at stake. Should the trial prove effective, the road will be paved for future studies. But if the new therapy is not effective, there is a fear that the public and policy makers may lose enthusiasm. Many researchers caution that high expectations need to be kept in check. California stem cell researcher Evan Snyder said, "If you had even bought Christopher Reeve an extra segment of spinal function he would [have been] off his ventilator. He would not be running a marathon, but you've changed his life."
The article also discusses the negative impact of President Bush's restrictive policies on federal funding for embryonic stem cell research. Present-elect Barack Obama has said he will lift federal funding restrictions as one of his first acts in office.
[UPDATE - 1/23/09: The FDA has approved Geron's request to begin clinical trials]