Feds to allow first human test of embryonic stem-cell treatment

SAN JOSE, Calif. (MCT) — A Menlo Park biotech company said Friday that federal regulators will let it proceed with the world's first human test of a treatment made from embryonic stem cells, a much-anticipated but controversial study of patients with spinal cord injuries that had been placed on hold for nearly a year because of safety concerns.

If the treatment from Geron works, it "would be revolutionary," said Dr. Richard Fessler, a neurological surgeon at Northwestern University, who will lead the study of a stem-cell treatment designed to be injected into patients with spinal injuries to restore their motor function. "The therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year." Geron has spent 15 years and more than $150 million to develop the treatment, and "getting it into a clinical trial, just by itself, is a big deal," added Fessler, who has no financial ties to the company.

Many people hope that human embryonic stem cells, which can turn into any type of tissue in the body, could prove useful for everything from generating organs for transplants to helping test drugs on numerous diseases. But because the cells are derived from discarded 3- to 5-day-old embryos, their use by researchers has sparked ethical concerns and a highly contentious national debate.

The U.S. Food and Drug Administration had put the study on hold last year after a few animals the company was testing with its treatment developed small cysts. Although similar cysts had appeared in earlier animal studies, they appeared with "a higher frequency" in more recent animals tests, the company said at the time.

FDA officials declined to comment on why they decided to lift their hold on the study. However, Geron said Friday that it determined the cysts "did not lead to any adverse consequences to the animals" and that the company changed some of its procedures "to minimize the likelihood of cyst formation." After Geron's announcement, its stock price rose 83 cents, or about 17 percent, to $5.63 at the close of trading.

In studies several years ago, Geron reported that its spinal treatment had helped paralyzed rats walk. The company's treatment involves turning embryonic cells into another type of cell, which helps nerve fibers replace myelin, a fatty insulating substance that often gets stripped away when spines are injured, inhibiting the body's ability to transmit sensory signals.