StemCells, Inc. Completes Enrollment of First Cohort in Phase II Pathway Study for Cervical Spinal Cord Injury

StemCells, Inc. STEM, a leading stem cell company developing novel cell-based therapeutics for treating diseases of the central nervous system with high unmet medical need, announced today that it has completed transplanting the six patients comprising the first cohort of its Phase II Pathway® Study. The first cohort is an open-label dose escalation arm to determine the cell dose to be used for the second cohort of the study. The second cohort of the study is a single-blind arm in 40 patients that will assess efficacy of the Company's proprietary HuCNS-SC® (purified human neural stem cells) platform technology for the treatment of cervical spinal cord injury (SCI). "We are breaking new ground with this study," said Stephen Huhn, M.D., FACS, FAAP, vice president, CNS clinical research and CMO at StemCells, Inc. "This is the first controlled study to use neural stem cells with the intent to demonstrate improvement in motor function following spinal cord injury. In this first cohort, we have achieved the highest number of neural stem cells administered into the injured human spinal cord in medical history. We expect to release six month interim data on the first cohort later this year. "Interest in this study from both physicians and patients has been very encouraging, resulting in the rapid enrollment of this cohort. The Company is using web-based recruitment and, in the first six months, we have seen over 1,500 inquiries and 500 completed questionnaires and over 100 subjects have been reviewed for possible eligibility. Our experience with the first cohort reflects great clinical momentum, as well as the excitement within the spinal cord injury community for potential novel treatments. Detecting evidence of motor improvement in this Phase II study would provide proof-of-concept for this approach in spinal cord injury and would ultimately lead to a therapy that dramatically enhances the quality of life for those afflicted with spinal cord injuries."