StemCells, Inc.'s Spinal Cord Injury Trial Approved by Health Canada

NEWARK, Calif., June 3, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today 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(R) 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 enrolment 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.

About the Spinal Cord Injury Clinical Trial

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.

All patients who enroll will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. Patients will be evaluated regularly in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any change in neurological function below the injury site. Preliminary efficacy will be evaluated based on defined clinical endpoints, such as changes in sensation, motor function and bowel/bladder function. The Company intends to follow the effects of this therapy long-term, and each of the patients will be invited to enroll into a separate four-year observational study after completing the Phase I/II study.

The trial is currently being conducted at Balgrist University Hospital, University of Zurich, a world-leading medical center for spinal cord injury and rehabilitation. If you believe you may qualify and are interested in participating in the study, please contact the study nurse either by phone at +41 44 386 39 01 or by email at stemcells.pz@balgrist.ch. The Company is working to open trial sites in Canada.

Information about the clinical trial is available at the ClinicalTrials.gov website of the National Institutes of Health at http://www.clinicaltrials.gov/ct2/show/NCT01321333?lead=StemCells+Inc.&rank=4. Additional information about the Company's spinal cord injury program can be found on the StemCells, Inc. website at http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm.

About StemCells, Inc.

See more here:
StemCells, Inc.'s Spinal Cord Injury Trial Approved by Health Canada