FDA OKs Embryonic Stem Cell Trials for Humans
Christopher Weber
Correspondent
Posted:
07/30/10
For the first time, human subjects will be used to test a treatment of spinal cord injuries derived from embryonic stem cells, under rules approved by the Food and Drug Administration.
The biopharmaceutical company Geron announced in a news release Friday that the FDA had lifted a hold on the clinical trial using human stem cells, The New York Times reported.
The hold was put into place shortly after the FDA initially cleared the research in January 2009. Regulators became concerned when cysts were discovered in some mice injected with the stem cells. Geron had to run another study on mice and come up with better ways to check the purity of its cells, the Times said.
Researchers believe embryonic stem cells have great promise in medicine because they're so resilient and malleable. Embryonic stem cells can turn into any type of cell in the body, which may mean they can someday be used to create replacements for injured or diseased tissues.
The biopharmaceutical company Geron announced in a news release Friday that the FDA had lifted a hold on the clinical trial using human stem cells, The New York Times reported.
The hold was put into place shortly after the FDA initially cleared the research in January 2009. Regulators became concerned when cysts were discovered in some mice injected with the stem cells. Geron had to run another study on mice and come up with better ways to check the purity of its cells, the Times said.
Researchers believe embryonic stem cells have great promise in medicine because they're so resilient and malleable. Embryonic stem cells can turn into any type of cell in the body, which may mean they can someday be used to create replacements for injured or diseased tissues. The cells have been controversial because creating them has required the destruction of human embryos, although researchers say they now avoid that practice, the Times said.