First patient treated in stem cell research

WASHINGTON - Doctors have injected millions of human embryonic stem cells into a patient partly paralyzed by a spinal cord injury, marking the beginning of the first carefully designed attempt to test the promising but controversial therapy, it was announced yesterday.

The patient was treated Friday at the Shepherd Center, a 132-bed hospital in Atlanta that specializes in spinal cord and brain injuries, according to the announcement by the hospital and Geron Corp. of Menlo Park, Calif., which is sponsoring the research.

The hospital is one of seven sites participating in the study, which is primarily aimed at testing whether the therapy is safe.

Doctors will conduct tests to see whether the treatment restores sensation or enables the patient to regain movement. No additional information about the first patient was released.

The milestone was welcomed by scientists eager to finally move the research from the laboratory to the clinic, as well as by advocates for patients and by patients hoping for cures. Although the cells have been tested in animals, and some clinics around the world claim to offer therapies using human embryonic stem cells, the trial is the first to have been vetted by a government entity and aimed at carefully evaluating the strategy. After repeated delays, the Food and Drug Administration gave the go-ahead in July.

But the move was criticized by those with moral objections to any research using cells from human embryos, and it is raising concern even among many proponents. Some argue that the experiments are premature, others question whether they are ethical, and many fear that the trials risk disaster for the field if anything goes awry.

"Without knowing more clinical detail, there's little I can say," said Steve Goldman, chairman of the department of neurology at the University of Rochester in New York. "In more general terms . . . I remain concerned about the long-term safety of unpurified grafts of embryonic stem cell derivatives. Time will tell."

David Prentice, senior fellow for life sciences at the Family Research Council, said: "Geron is helping their stock price, not science and especially not patients. It will be years before there is hard evidence about safety or effectiveness. Adult stem cells have published evidence documenting effective treatment of spinal cord injury."

Supporters of the privately funded research are confident that it has been exhaustively vetted. The FDA has demanded extensive experiments in the laboratory and on animals to provide evidence that the cells hold promise and are safe enough to test in people.

"Initiating the . . . clinical trial is a milestone for the field of human embryonic stem cell-based therapies," said Thomas B. Okarma, Geron's president and chief executive, in a statement.

But some scientists worry that if patients are hurt by the cells, or even if there's no hint that the cells help, it could be a devastating blow to the field. They cite the case of Jesse Gelsinger, whose 1999 death from a gene therapy experiment set that once-highly touted field back years.