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From the start, Geron's MO has been to put foot to accelator. It is, after all, a company ($200 million in the bank) whose primary goal—for patients and, of course, stockholders—is to get a treatment to market. In 2001 it funded Keirstead's research, which tested a therapy manufactured from human embryonic stem cells (from a Bush-approved cell line), called oligodendrocyte progenitor cells, in rats with a partial spinal-cord injury. When the cells were injected into the damaged area, they restored the spinal cord's insulation, which conducts nerve impulses from the brain to the rest of the body, allowing movement. In Keirstead's study, rats who had 10-month-old injuries didn't improve because too much scarring had developed. But the outcome was striking in animals whose injuries were just seven days old. Two months after treatment, rats who'd lost control of their trunk muscles, tail and hind legs—they could move, but not much—now exhibited "substantially improved locomotor ability." They could walk.
Nice if you're a rat. Now the company had to figure out how to move the cells into humans. It spent years creating the optimal oligodendrocyte progenitor cell, then focused on how to make a bunch of them identically under strict quality control—a process that's a whole lot harder with a living cell than a pill. It even designed a computer-controlled device to position the syringe and control the injection to be sure that the right number of cells went to the right spot. By the time Geron filed its application to the FDA last year, it had 22,500 pages of documentation. Total count: 24 studies, 1,977 rodents, $45 million.
Now Geron is negotiating with up to eight neurotrauma centers to conduct human trials. It will be recruiting people who have injuries in the thoracic, or middle region of the spine—paraplegics who are paralyzed from the chest area down. Because the injuries must be new—less than 14 days old—the patients Geron wants to start enrolling this summer are actually healthy people today who haven't yet been injured. But that hasn't stopped the interest among people who are already paralyzed. When the FDA approval was announced in January, Geron's voice-mail system broke down from the flood of calls.