The Medical College of Wisconsin has been selected as one of just seven sites nationwide for a groundbreaking clinical trial using human embryonic stem cells (hESC) to treat spinal cord injury.
The primary investigator is Shekar Kurpad, MD, associate professor of neurosurgery at the College. A total of ten patients will be enrolled nationwide in the Phase I study, which seeks to assess the safety and tolerability of hESC-derived oligodendrocyte progenitor cells. In animal studies, oligodendrocyte progenitor cells were shown to enhance remyelination of the spinal cord, and promote improvement of motor function.
The oligodendrocyte progenitor cells, or GRNOPC1, will be administered to patients with complete American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries. Participants in the study must be newly injured and receive GRNOPC1 within 14 days of the injury.
“This is a milestone in the fields of both stem cell and spinal cord research,” said Dr. Kurpad, who practices and will lead the trial at Froedtert Hospital. “Spinal cord injury is devastating to patients. We are hopeful that this trial will lead to increased knowledge about the possibility of regeneration of the spinal cord.” Spinal cord injury is caused by trauma to the spinal cord that results in a loss of motor control, sensory perception, or bowel and bladder control. A blow to the spine can fracture or dislocate vertebrae that then injure the cells insulating the spinal cord. Every year, 12,000 people in the United States sustain spinal cord injuries. There are currently no approved therapies to treat spinal cord injury.
To date, two patients have been enrolled in the study. Neither suffered adverse effects related to the injection procedure or the GRNOPC1. As a result, the FDA has expanded the eligibility for the trial. Further information on the eligibility criteria is available on www.clinicaltrials.gov