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US give Geron Go-ahead for ESC Trial for Spinal Cord Injury

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The US Food and Drug Administration (FDA) has authorised Geron to carry out the world's first clinical trial using human embryonic stem cells (hESC) in patients with acute spinal cord injury. GRNOPC1 contains hESC-derived oligodendrocyte progenitor cells that have been shown to have the ability to restore function in animal models of acute spinal cord injury (Keirstead et al.). The Phase I clinical trial won initial approval in January last year but was delayed due to safety concerns raised in animal studies in which a higher frequency of small cysts was observed within the injury site in the spinal cord of animals injected than in other studies. However, further studies in rats addressed these safety concerns and Geron now plans to test the therapy on around 10 volunteer patients paralysed by spinal cord injuries. The initial phase will be testing for safety and Geron has selected up to seven U.S. medical centres as candidates to participate in this study and in planned protocol extensions.

Sources

Daily Telegraph (UK)

Financial Times (UK)

Medical News Today

Associated Press

Keirstead, H.S., G. Nistor, G. Bernal, M. Totoiu, F. Cloutier, K. Sharp, and O. Steward, Human embryonic stem cell-derived oligodendrocyte progenitor cell transplants remyelinate and restore locomotion after spinal cord injury. J Neurosci, 2005. 25(19): p. 4694-705.