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Why have they done so?
StemCells, Inc. (Nasdaq:STEM), a world leader in the research and development of cell-based therapeutics for the treatment of central nervous system diseases and disorders, announced today that Health Canada has authorized the Company to expand its Phase II clinical trial for chronic cervical spinal cord injury into Canada. The Pathway Study is designed to assess the efficacy of the Company’s proprietary HuCNS-SC® platform technology (purified human neural stem cells) for the treatment of cervical spinal cord injury with the primary efficacy outcome being the change in motor strength of the various muscle groups in the upper extremities innervated by the cervical spinal cord.
“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,” said Stephen Huhn, M.D., FACS, FAAP, Vice President, Clinical Research and CMO at StemCells, Inc. “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.”
About the Pathway Cervical Spinal Cord Injury Clinical Trial
The Company’s Phase II Pathway Study, titled “Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury,” will evaluate the safety and efficacy of transplanting the Company’s proprietary human neural stem cells (HuCNS-SC cells), into patients with traumatic injury in the cervical region of the spinal cord. Conducted as a randomized, controlled, single-blind study, the trial will measure efficacy by assessing motor function according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). The primary efficacy outcome will focus on change in upper extremity strength. The trial will enroll approximately 52 subjects and follow the patients for 12 months post-transplant. The first cohort of six patients completed enrollment in April and was designed to establish the cell dose for onward testing in the second cohort of the study.
