MENLO PARK, Calif., August 18, 2009 – Geron Corporation announced that its IND (Investigational New Drug application) for GRNOPC1, a cell therapy for neurologically complete, subacute spinal cord injury, has been placed on clinical hold by the FDA pending the agency’s review of new nonclinical animal study data submitted by the company. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing trial.
Since filing the IND, Geron has been undertaking studies to enable dose escalation of its spinal cord injury product, and has been investigating application
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A stem cell injection bound to create a stir is about to take place. For the first time ever the Food and Drug Administration (FDA) (the United States government agency regulating scientific research) has authorized a company to transfer embryonic stem cells to patients paralyzed by spinal trauma. It will be the first procedure of its kind after newly inaugurated President Barack Obama promised to remove limits on financing for embryonic stem cell research imposed by George Bush in 2001.
The details of the initiative are beginning to take form, explained Thomas Okarma,
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Scientists have improved the sight of two people who were almost blind by injecting their eyes with stem cells from embryos.
The two women, both registered as blind, saw their vision improve in a matter of weeks after being given the embryo-derived cells in the US safety trial.
The breakthrough holds out the hope of a cure in the future for age-related macular degeneration, which currently affects some 500,000 people in Britain.
The results, published this week in The Lancet, provide a major boost for the field of stem cell reseach.
Professor Daniel Brison, of the North West Embryonic