News Section | Stem Cell Research
US approves stem-cell therapy for humans
The US Food and Drug Administration (FDA) has given a green signal to a clinical trial of embryonic stem cells as a treatment for spinal-cord injury.
This is the first time embryonic stem cells will be tested on humans.
Geron Corporation, which developed the treatment, said the FDA had removed a clinical hold on its GRNOPC1 therapy.
Stem cells and precursor cells: Shown is a drawing of a stem cell maturing into one of three types of mature blood cells: red blood cells, platelets, and white blood cells. Precursor cells are also shown: stem cells, myeloid blasts, lymphoid stem cells, and lymphoid blasts. (Credit:NCI)
The trial will last about two years, with each patient being studied for one year.
The FDA accepted Geron”s January 2009 study application, but then placed any potential study on hold last August because some mice treated with GRNOPC1 developed spinal cysts, reports The Sydney Morning Herald.
However, Geron claims to have found a new way to test GRNOPC1 and said it did not see any cysts in a separate animal study.
A successful test would lead to larger and longer studies that would focus on the effectiveness of GRNOPC1.
The company says it will monitor patients for 15 years for safety.
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