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NEWARK, Calif., March 12, 2014 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM), a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2013.
"2013 was a year of significant clinical and regulatory progress for StemCells, Inc. moving us closer to our goal of bringing a truly disruptive therapeutic to the clinic for a broad array of diseases and conditions affecting the central nervous system (CNS)," said Martin McGlynn, President and CEO of StemCells, Inc. "We received approval to expand our Phase I/II thoracic spinal cord injury trial from Switzerland into Canada and the United States, which should enable us to complete enrollment in our Phase I/II study this quarter. In addition, the FDA authorized us to increase the number of clinical sites from two to five, in our Phase I/II study in dry age-related macular degeneration, which will enable us to complete enrollment later this year. We look forward to the completion of these studies and the clinical insights they will give us.
"As pleased as I am about these accomplishments, I am most excited about our agenda for this year. We plan to initiate two randomized controlled phase II studies, both of which will assess proof of concept for our technology later this year: one for spinal cord injury, which will include cervical injury, and the other for dry age-related macular degeneration. These clinical trials further solidify our leadership position in the development of neural stem cell based therapeutics for disorders of the CNS. We are excited to be transitioning from single center open label Phase I studies to multicenter Phase II controlled studies designed to give us definitive efficacy data. "