Stemcells (STEM) Reports Successful First Transplant in HuCNS-SC in Phase I/II

January 10, 2014 8:07 AM EST
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Stemcells (Nasdaq: STEM) 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."

"We have closely followed the conduct of the StemCells, Inc. trial at the University of Zurich, under the direction of Dr. Armin Curt," said Michael Fehlings M.D., Ph.D., FACS, FRCSC. Dr. Fehlings is Medical Director of the Krembil Neuroscience Centre, Professor of Neurosurgery at the University of Toronto, head of the Spinal Program at the Toronto Western Hospital, and principal investigator for the trial at the University of Toronto. "There is a large unmet medical need for treatments in spinal cord injury. The opening of sites in North America is great news for the worldwide community of patients and their families, as well as for researchers. There is a strong rationale to explore novel therapeutic approaches to treating spinal cord injury, and we are pleased to be working with StemCells at the forefront of this trailblazing study."

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