NEWARK, Calif., Dec. 18, 2014 (GLOBE NEWSWIRE) --

StemCells, Inc. (Nasdaq:STEM), a world leader in the research and development of cell-based therapeutics for the treatment of disorders of the central nervous system, announced today that it has transplanted the first subject in its Phase II Pathway? Study assessing the efficacy of its proprietary HuCNS-SC? (purified human neural stem cells) platform technology for the treatment of cervical spinal cord injury (SCI). The transplant was performed at the University of Miami Hospital within the Miller School of Medicine, home to The Miami Project to Cure Paralysis, one of the world's most comprehensive spinal cord injury research centers dedicated to finding effective treatments for paralysis.

"The participant tolerated the procedure well and is recovering from the surgery as expected," said Allan D. Levi, M.D., Ph.D., F.A.C.S., Robert M. Buck Distinguished Chair in Neurological Surgery at the University of Miami Miller School of Medicine and Principal Investigator for the center. "Our center is a leader in clinical research aimed at curing paralysis, and we are excited to be participating in this breakthrough approach to spinal cord injury repair. The Pathway study is designed to measure the potential of these human neural stem cells, HuCNS-SC, as a possible treatment for repairing some aspects of spinal cord injury. Restoring or improving motor function would be life changing for these patients."

The Pathway Study is the first clinical trial designed to evaluate both the safety and efficacy of transplanting human neural stem cells into patients with cervical spinal cord injury. Traumatic injuries to the cervical (neck) region of the spinal cord, also known as tetraplegia or quadriplegia, impair sensation and motor function of the hands, arms, legs, and trunk. The trial will be conducted as a randomized, controlled, single-blind study and efficacy will be primarily measured by assessing motor function according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). The primary efficacy outcome will focus on change in upper extremity strength as measured in the hands, arms, and shoulders. The trial will follow the participants for one year and will enroll up to 52 subjects.

"We are working with all due speed to pioneer a revolutionary therapeutic approach for victims of spinal cord injury, a debilitating condition that has significant unmet need and no effective treatment," said Stephen Huhn, M.D., FACS, FAAP, Vice President, Clinical Research and CMO at StemCells, Inc. "Enrollment of the first patient with cervical injury is an important step in our clinical development, which ultimately has the goal of improving motor function and restoring a level of independence for individuals living with chronic spinal cord injury. The Pathway Study is a natural evolution from our Phase I/II trial in thoracic spinal cord injury."

The Company completed enrollment and dosing in its open-label Phase I/II study in thoracic spinal cord injury in May 2014 and has reported interim results on all 12 subjects. Post-transplant gains in sensory function below the level of injury were demonstrated in half of the subjects. Two subjects converted from a complete injury (AIS A) to an incomplete injury (AIS B). The interim results also continue to confirm the favorable safety profile of the cells and the surgical procedure.

About the Pathway Spinal Cord Injury Clinical Trial

The StemCells, Inc. Pathway Phase II clinical trial, titled "Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury," will evaluate the safety and efficacy of transplanting the Company's proprietary human neural stem cells (HuCNS-SC cells), into patients with traumatic injury in the cervical region of the spinal cord. Conducted as a randomized, controlled, single-blind study, the trial will measure efficacy by assessing motor function according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). The primary efficacy outcome will focus on change in upper extremity strength as measured in the hands, arms and shoulders. The trial will enroll approximately 52 subjects and follow the patients for 12 months post-transplant. - See more at:

http://globenewswire.com/news-releas....rrQXwwDL.dpuf