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Clinical Trial of Stem Cell Therapy Underway

Model of spine (NIH)


Geron Corporation in Menlo Park, California said today the first patient has enrolled in the clinical trial of its drug GRNOPC1, that contains oligodendrocyte progenitor cells derived from human embryonic stem cells (hESC). The objective of this Phase 1 study is to assess the safety and tolerability of GRNOPC1 in patients with complete American Spinal Injury Association Impairment Scale grade A thoracic spinal cord injuries.

Participants in the study are newly injured and receive GRNOPC1 within 14 days of the injury. This first patient was enrolled at Shepherd Center, a 132-bed spinal cord and brain injury rehabilitation hospital and clinical research center in Atlanta, Georgia. Shepherd Center is one of seven potential sites in the U.S. for patients in the clinical trial.

The American Spinal Injury Association Impairment Scale defines grade A subacute thoracic spinal cord injuries as having no motor and sensory function in the anal and perineal region representing the lowest sacral cord (S4-S5).

Geron says GRNOPC1 contains hESC-derived oligodendrocyte progenitor cells that have demonstrated nerve regenerative and growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury. Preclinical studies showed that administration of GRNOPC1 significantly improved locomotor activity and kinematic scores of animals with spinal cord injuries when injected seven days after the injury.

Related: Clinical Trial of Embryonic Stem Cell Therapy Authorized

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