First patient treated in stem cell study

WASHINGTON — Doctors have injected millions of human embryonic stem cells into a patient partially paralyzed by a spinal cord injury, marking the beginning of the first carefully designed attempt to test the promising but controversial therapy, officials announced Monday.

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 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 also 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."

Supporters are confident that trial has been exhaustively vetted. The FDA received evidence that the cells hold promise and are safe enough to test in people.

First patient treated in stem cell study 10/12/10 [Last modified: Tuesday, October 12, 2010 12:16am]

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