Health Canada has granted approval for StemCells to expand its Phase II clinical trial (Pathway Study) to evaluate the efficacy of company's HuCNS-SC platform technology for chronic cervical spinal cord injury.
The Phase II Pathway Study’s primary efficacy outcome is the change in motor strength of the various muscle groups in the upper extremities innervated by the cervical spinal cord.
StemCells Clinical Research vice-president and CMO Stephen Huhn said: "This authorization should be very welcome news for spinal cord injury patients in Canada who will now have easier access to participate in the study.
"This will allow expansion of the number of clinical trial sites and patients with spinal cord injury that the company can include in our ongoing Pathway study.
"This will allow us to continue enrolling this breakthrough study in a very efficient fashion."
The trial will evaluate the safety and efficacy of transplanting the company’s human neural stem cells (HuCNS-SC cells), into patients with traumatic injury in the cervical region of the spinal cord.
The randomized, controlled, single-blind trial will measure efficacy by evaluating motor function according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
Around 52 subjects will be enrolled in this trial and they will be followed for 12 months post-transplant.