Safety data to date from the trial has shown:
- No surgical complications during or after the procedures.
- No adverse events related to the injection procedures or to GRNOPC1.
- A few mild adverse events related to tacrolimus.
- No evidence of cavitation in the spinal cord at the injury sites on MRI.
- No unexpected neurological changes.
- No evidence of immune responses to GRNOPC1.
GRNOPC1 was delivered to four spinal cord injured patients at a dose of two million cells without complications from either the cells or the surgical procedure itself, and without any negative effects on the spinal cord or neurological function of the patients to date. The only side-effects observed were due to the immunosuppressive drug tacrolimus, which is administered for the first two months after injection of GRNOPC1. Furthermore, there is no evidence to date of immune rejection of GRNOPC1, an allogeneic cell therapy, including after withdrawal of immunosuppressive drug.
GRNOPC1 contains hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating, nerve growth stimulating and angiogenic properties leading to restoration of function in rodent models of acute spinal cord injury. Preclinical studies have shown that administration of GRNOPC1 significantly improved locomotor activity and kinematic scores of rodents with spinal cord injuries when injected seven days after the injury. Histological examination of the injured spinal cords treated with GRNOPC1 showed improved axon survival and extensive remyelination surrounding the rodent axons. For more information about GRNOPC1, visit www.geron.com/GRNOPC1Trial/. For further information about the Phase 1 clinical trial, including location of clinical sites, visit http://clinicaltrials.gov/ct2/show/NCT01217008.About Spinal Cord Injury Spinal cord injury is caused by trauma to the spinal cord that results in a loss of motor control, sensatory perception, bowel and bladder control, and numerous other voluntary or involuntary body functions. A traumatic blow to the spine can fracture or dislocate vertebrae that may cause bone fragments or disc material to injure the nerve fibers and damage the oligodendrocyte cells that insulate the nerve fibers in the spinal cord. Most human spinal cord injuries are contusions (bruises) rather than lacerations to the cord. Every year approximately 12,000 people in the U.S. sustain spinal cord injuries. There are currently no approved therapies for the treatment of spinal cord injury.