StemCells, Inc. announced that Health Canada has authorized the Company to expand its Phase I/II clinical trial for chronic spinal cord injury into Canada. The Phase I/II trial, currently underway in Zurich, Switzerland, is designed to evaluate the safety and preliminary efficacy of the Company’s proprietary HuCNS-SC® product candidate (purified human neural stem cells) as a treatment for chronic spinal cord injury. With this authorization from Health Canada, the Company is actively working to open one or more trial sites in Canada and begin screening patients.
“This should be very welcome news for spinal cord injury patients in North America,” said Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. “One of the patients in our trial is a Canadian and he endured some challenging logistics to get to and from Switzerland. The addition of sites located in North America will significantly ease the burden on Canada- and US-based patients and their families who may wish to participate in our trial.
“In addition, given the excellent safety profile and encouraging results seen to date in the three patients with complete injury, we have amended the clinical protocol to allow continued enrollment of patients with complete injury in addition to patients with the less severe, or incomplete injury. We are confident that the amended protocol combined with the addition of North American trial sites will accelerate enrollment of patients with varying degrees of spinal cord injury.”
To date, four patients have been enrolled in the Company’s Phase I/II trial and transplanted with HuCNS-SC cells. The first three patients had all suffered a complete injury to the thoracic (chest-level) spinal cord, classified as AIS A according to the American Spinal Injury Association Impairment Scale (AIS). In a complete injury, there is no neurological function below the level of injury, and sensory function of all three patients was stable before transplantation of the HuCNS-SC cells. The first three patients completed the trial in December 2012 and data from these patients showed multi-segment gains in sensory function in two patients twelve months post-transplantation of the HuCNS-SC cells. One of these two patients converted from a complete injury classification to an incomplete injury, while the third patient remained stable. Unlike the first three patients, the fourth patient in the study had suffered an incomplete injury, classified as AIS B, because of preserved sensory function below the level of injury.
The Phase I/II clinical trial of the Company’s HuCNS-SC cells is designed to assess both safety and preliminary efficacy. The Company anticipates twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level will be enrolled. The trial is open to patients in Europe and North America with a complete or incomplete injury classified according to the American Spinal Injury Association Impairment Scale. In a complete injury, there is no neurological function below the level of injury, while in an incomplete injury, there is some preservation of function below the level of injury.