Researchers are exploring a new therapy using stem cells to treat spinal cord injuries within the first 14 to 30 days of injury.
The therapy uses a population of cells derived from human embryonic stem cells containing progenitor cells that support nerve cells and can possibly improve the functioning of nerves.
“There are currently no therapies which successfully reverse the damage seen in the more than 12,000 individuals who suffer a spinal cord injury each year in the United States alone,” said Dr. Richard G. Fessler, professor of neurological surgery at Rush University Medical Center, which is only the second center in the U.S. currently studying this new treatment. Approximately 1.3 million Americans are living with a spinal cord injury.
“These injuries can be devastating, causing both emotional and physical distress, but there is now hope. This is a new era where we are now able to test whether a dose of stem cells delivered directly to the injured site can have an impact on motor or sensory function,” Fessler said. “If we could generate even modest improvements in motor or sensory function, it would result in significant improvements in quality of life.”
The clinical trial is designed to assess safety and activity of escalating doses of the special cells (AST-OPC1) for individuals with a complete cervical spinal cord injury. Thus far, one individual has been enrolled in the study at Rush. Fessler said the procedure to inject AST-OPC1 went well and there were no complications.
The trial involves testing three increasing doses of AST-OPC1 in patients with a cervical spinal cord injury where they have lost all sensation below their injury site with severe paralysis of the upper and lower limbs. AST-OPC1 is administered 14 to 30 days after the injury. Patients will be followed by neurological exams to assess the safety and activity of the product.
“In the future, this treatment may be used for peripheral nerve injury or other conditions which affect the spinal cord, such as MS or ALS,” Fessler said.
For this therapy to work, the spinal cord has to be in continuity and not severed, according to Fessler. The study seeks male and female patients ages 18 to 65 who recently experienced a complete cervical spinal cord injury at the neck that resulted in paralysis of the arms, legs and torso. Patients must be able to start screening within 25 days of their injury, and participate in a surgical procedure to inject AST-OPC1 14 to 30 days after the injury. Participants also must be able to commit to a long-term follow-up study.
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