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Scott P. Roy

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July 30, 2010 - Geron Corporation announced that the US Food and Drug Administration (FDA) has notified the company that the clinical hold placed on their Investigational New Drug (IND) application had been lifted and the company’s Phase I clinical trial of human embryonic stem cell-derived oligodendrocyte progenitor cells (GRNOPC1) in patients with acute spinal cord injury may proceed. The Miami Project to Cure Paralysis congratulate Geron corporation and its scientists for their tenacity in satisfying the FDA's requirements to secure permission to test hESC-derived oligodendrocyte progenitor cells in acute patients with spinal cord injury. The first testing in humans of partially differentiated embryonic stem cells is an important milestone in the history of modern medicine. We should emphasize optimism for SCI patients that the protocol has been approved in the US.

Over the past year Geron and Miami Project scientists have been cooperating to test and optimize cell delivery techniques in a experimental spinal cord injury model. Both parties have benefited from the consultation and collaboration which will improve injection safety in patients. The Geron safety trial will involve multiple study sites to increase the number of participating SCI subjects. The Miami Project is in initial discussions to participate as a study site.

Cell therapy for spinal cord injury is a new form of treatment, which like other new treatments in medicine will require multiple studies for its benefits and risks to be clarified. The Miami Project to Cure Paralysis is also moving their human Schwann Cell transplantation trial forward and has just completed a very successful pre-IND meeting with the FDA and anticipate IND submission and approval next year. In this Phase I trial, Miami Project investigators are planning to use a patient’s own Schwann Cells to promote remyelination and nerve growth in patients with subacute spinal cord injuries. Human adult Schwann Cells may have less risks in terms of potential tumor formation than stem cells. In contrast to  using embryonic stem cells, immune suppression of the SCI patients is not required for the Schwann cell trial since the patient’s own cells are being used in the transplantation procedure. Further trials involving chronically injured subjects are being evaluated and will be advanced subsequent to the Phase 1 trial.


For more information please visit the Clinical Trials Initiative on our website.

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