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."

"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."

About the StemCells, Inc. Spinal Cord Injury Clinical Trial

The Company's Phase I/II clinical trial is designed to assess both safety and preliminary efficacy of HuCNS-SC cells as a treatment for chronic spinal cord injury. The Company plans to enroll 12 subjects with thoracic (chest-level) neurological injuries at the T2-T11 level, classified as complete or incomplete according to the American Spinal Injury Association Impairment Scale.

To date, nine patients have been enrolled and transplanted with HuCNS-SC cells.Each of the first three subjects suffered a complete injury prior to enrolling in the study. Twelve months after transplantation of the HuCNS-SC cells, data showed multi-segment gains in sensory function in two of the first three subjects, one of which converted from a complete injury classification to an incomplete injury.The third subject in this cohort remained stable, 12 months after transplantation. The company expects to report additional interim data on both the first and second cohorts by mid-2014.

The trial is currently enrolling spinal cord injury patients at three centers: the University of Calgary; the University of Toronto; and at Balgrist University Hospital, University of Zurich, a world-leading medical center for spinal cord injury and rehabilitation. Patients who may qualify and are interested in participating in the study in North America should contact the University of Calgary at 403-944-4334 or the University of Toronto at 416-603-5285. For information on enrollment in Switzerland, interested parties may contact the study nurse either by phone at +41 44 386 39 01, or by email at stemcells.pz@balgrist.ch.

All subjects who enroll in the trial will receive HuCNS-SC cells through direct transplantation into the spinal cord and will undergo temporary treatment with immunosuppressive drugs.Evaluations will be regularly performed 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.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 intervention long term, and each of the subjects will be invited to enroll in a separate four-year observational study after completing the Phase I/II study.In addition, the Company plans to initiate a controlled Phase II efficacy trial in in spinal cord injury in 2014.

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