Monday, November 07, 2005

Researchers Want to Test Stem Cell Spinal Treatment in People

Researchers Want to Test Stem Cell Spinal Treatment in People

The San Jose Mercury News reported today that the California biotech company Geron hopes to begin clinical trials injecting stem cells into damaged spinal cords. (Note: The full article may be available only through free registration to the on-line paper. Because of the number of biotech companies in the San Jose area, the Mercury News often reports on stem cell technology issues.) Geron hopes to get permission from the FDA to begin safety trials next year.

The news was received with concern by some stem cell researchers, who believe that more animal trials are needed. They are worried about the potential for the stem cells to cause cancer or other health problems in the patients. Jerry Silver, a neuroscience professor and stem-cell researcher at Case Western Reserve University in Cleveland, wanted to see more trials on higher level mammals first and was quoted in the article as saying, “Many treatments that work in rodents to alleviate disease fail miserably in humans.” Other scientists worry that the injuries that the test animals have sustained are not the same as the ones that people might have suffered. There is also concern that the embryonic stem cells might be from the lines which have been contaminated with mouse cells. However, Dr. Irving Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine, was quoted as saying that he saw no reason for the FDA to turn down Geron’s request or require further testing.

According to the article,
For its test, Geron proposes to turn human embryonic stem cells into the precursors for specialized nerve cells, called oligodendrocyte progenitor cells. Surgeons then would inject the cells into the spinal injury with the help of a special stabilizing frame the company has developed.

If everything goes as planned, the progenitor cells would help form new axons and also turn into oligodendrocytes, which help form an insulating sheath for the axons, called myelin.

The trials would involve only a few dozen patients and would begin as a safety trial before moving to a therapeutic phase.

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