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Breaking News, Trials & Filings

Stem Cells Gets First NA Spinal Subject

Trial expands from Switzerland base

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The first North American patient has been treated in StemCells, Inc.‘s Phase I/II clinical trial in chronic spinal cord injury. A team at the University of Calgary successfully transplanted its first subject with the company’s proprietary HuCNS-SC human neural stem cells. The patient is the ninth subject to enroll in the trial, which was initiated in Switzerland.
 
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 in 1Q14, and pave the way for a controlled Phase II efficacy study that the company plans to initiate mid-year to investigate HuCNS-SC as a treatment for spinal cord injury.
 
ThePhase 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. 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. 

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