A research team from Rush University Medical Center has begun a new trial to study a therapy using stem cells to treat spinal cord injuries within the first 14 to 30 days of injury.
A release from Rush University Medical Center explains that the Phase 1 clinical trial involves AST-OPC1 (oligodendrocyte progenitor cells). These cells are derived from human embryonic stem cells, and contain progenitor cells that support nerve cells and can potentially make poorly functioning nerves function better.
“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,” says Richard G. Fessler, MD, PhD, professor of neurological surgery at Rush University Medical Center and the study’s principal investigator, in the release.
“If we could generate even modest improvements in motor or sensory function, it would result in significant improvements in quality of life,” he continues.
According to the release, 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.
“The surgical procedure to inject AST-OPC1 went very well, and there were no intraoperative complications,” Fessler states in the release.
The trial involves testing three escalating doses of AST-OPC1 in patients with subacute, C5-C7, neurologically complete cervical spinal cord injury. These individuals have essentially lost all sensation and movement below their injury site with severe paralysis of the upper and lower limbs. AST-OPC1 is administered 14 to 30 days postinjury. Patients will be followed by neurological exams and imaging methods to assess the safety and activity of the product, the release explains.
Fessler notes in the release that in the future, this treatment may be used for peripheral nerve injury or other conditions that affect the spinal cord, such as MS or ALS. However, he states, for this therapy to work, the cord has to be in continuity and not severed.
Researchers are seeking male and female patients ages 18 to 65 who recently experienced a complete cervical spinal cord injury at the neck that resulted in tetraplegia, the partial or total paralysis of arms, legs and torso.
Patients must be able to start screening within 25 days of their injury, and participate in an elective surgical procedure to inject AST-OPC1 14 to 30 days following injury. Participants also must be able to provide consent and commit to a long-term follow-up study, according to the release.
[Source(s): Rush University Medical Center, Newswise]