Geron, a California company developing therapies derived from embryonic stem cells, announced on Monday that the first patient has been treated in its landmark trial for spinal cord injury. The therapy, which involves injecting differentiated neural cells into the injury site, is the first such treatment to be tested in humans. Other experimental stem cell therapies involve adult stem cells or cells derived from fetuses.
Geron first garnered approval for the tests from the U.S. Food and Drug Administration in January of 2009. But that approval was put on hold several months later due to new safety concerns from animal tests. Because cells can behave unpredictably, regulators want to make sure the transplanted cells don’t develop into teratomas, a type of tumor associated with the injection of embryonic stem cells.The FDA gave permission to resume testing in July, after another round of animal safety tests. This early stage trial is designed to assess the safety of the therapy in humans and will involve a small number of patients with new injuries; the treatment must be delivered within 14 days of the injury.
The cell therapy is made by transforming embryonic stem cells into oligodendrocytes–a type of brain cell that wraps itself around neurons, forming a fatty insulation layer that allows electrical messages to be conducted throughout the nervous system. These cells are often damaged in spinal cord injury, while the underlying nerve cells remain intact. When the new cells are injected into the site of the injury in animals, they coat exposed nerves and restore communication to the nervous system.
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