Ushering in a new era in medicine, the U.S. Food and Drug Administration said Friday that it had cleared the way for the world's first clinical trial of a therapy derived from human embryonic stem cells. By early summer, a handful of patients with severe spinal cord injuries will be eligible for injections of specialized nerve cells designed to enable electrical signals to travel between the brain and the rest of the body. When the cells were administered to rats that had lost control of their hind legs, they regained the ability to walk and run, albeit with a limp.
As a Phase I trial, the study will primarily assess the safety of the treatment, which has been under development by Menlo Park, Calif.-based Geron Corp. for nearly a decade. But scientists, doctors and patients said they were most eager to see whether low doses of the cells would produce any therapeutic benefit. If so, it would help validate years of hope and investment in the nascent field of regenerative medicine. Besides patients with spinal cord injuries, stem cell therapies could ultimately benefit people with such intractable diseases as Alzheimer's, Parkinson's and multiple sclerosis.