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StemCells, Inc. Expands Phase I/II Spinal Cord Injury Trial To North America

NEWARK, Calif., Jan. 10, 2014 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM) announced today that a team at the University of Calgary successfully transplanted its first subject in the Company's Phase I/II clinical trial in chronic spinal cord injury, with the Company's proprietary HuCNS-SC® human neural stem cells. The ninth subject to enroll in the trial, which was initiated in Switzerland, is the first spinal cord injury patient to have undergone transplantation in North America. This expansion from a single-site, single-country study to a multi-site, multi-country program accelerates the current trial, which should complete enrollment of the remaining three patients this quarter, and pave the way for a controlled Phase II efficacy study that StemCells, Inc. plans to initiate mid-year to further investigate its HuCNS-SC product candidate as a treatment for spinal cord injury.

"With this transplantation in Canada, we have the first international trial investigating neural stem cells for spinal cord injury," said Stephen Huhn, M.D., FACS, FAAP, Vice President, CNS Clinical Research at StemCells, Inc. "The 12-month data from the first cohort has demonstrated a favorable safety profile, and sensory gains first detected in two of the three subjects at the six-month assessment have persisted. The third subject remains stable. We are extremely encouraged with the progress of our spinal cord injury program and the transition into an international study will accelerate completion of enrollment."

Steve Casha, M.D., Ph.D., FRCSC, the principal investigator at the University of Calgary, added, "We are proud to be the first center to enroll a subject in North America. This important research is yielding critical insight into the use of stem cells in treating spinal cord injury patients. The results should serve as a solid foundation for the Company's planned Phase II controlled efficacy study and represents an important step in the development of this promising technology."

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