(Editor’s note: This will have implications for Dejerine-Sottas research in the future:)
Using human embryonic stem cells, the Menlo Park company has developed a therapy that enables paralyzed rats to walk and that it claims shows no dangerous side effects in experiments with about 2,000 animals.
Others also are studying such cells for medical uses, including Stanford University scientists, who last week said they had used them to help stroke-disabled lab rats walk better. But none are as close to seeking permission for human tests as Geron, whose treatment is for spinal injuries.
For its application requesting regulatory approval from the U.S. Food and Drug Administration, the public company has gathered 25,000 pages of data – far more than normal for such requests, Geron Chief Executive Dr. Thomas Okarma said. He told analysts recently that Geron would submit it to the FDA during the first part of this year. But he declined to reveal the actual filing date, he said, “to minimize any kind of pressure on the agency.”
Yet Geron’s bid isn’t certain.
Although the FDA would not comment on Geron’s application, President Bush objects to most research with embryonic stem cells, which come from discarded embryos. Moreover, his administration has become intrigued with recent studies showing skin cells can be manipulated to have embryonic-like properties without harming an embryo.
Read the rest of One Big Step for Geron.