OREANDA-NEWS. StemCells, Inc. (NASDAQ:STEM), a world leader in the research and development of cell-based therapeutics for the treatment of central nervous system disorders, today announced the company’s ongoing Phase II Pathway™ Study in cervical spinal cord injury (SCI) was featured in an article published in The Downey Patriot.

For the story entitled “Rancho Los Amigos partners with USC for groundbreaking stem cell research,” Christian Brown spoke with Dr. Charles Liu, Associate Chief Medical Officer and Chair of Neurosurgery and Spine at Rancho Los Amigos National Rehabilitation Center in Downey, Ca., and Principal Investigator of the trial, and Dr. Stephen Huhn, Vice President of Clinical Research and Chief Medical Officer at StemCells, Inc.

The Phase II Pathway Study, 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-blinded 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 in three cohorts.  Enrollment in the first cohort of six subjects has been completed.  The Company is actively enrolling 40 patients in cohort II.

StemCells, Inc. has demonstrated human safety data from completed and ongoing clinical studies in which its proprietary HuCNS-SC cells have been transplanted directly into all three components of the central nervous system: the brain, the spinal cord and the eye. StemCells, Inc. clinicians and scientists believe that HuCNS-SC cells may have broad therapeutic application for many diseases and disorders of the CNS. Because the transplanted HuCNS-SC cells have been shown to engraft and survive long-term, there is the possibility of a durable clinical effect following a single transplantation. The HuCNS-SC platform technology is a highly purified composition of human neural stem cells (tissue-derived or “adult” stem cells). Manufactured under cGMP standards, the Company’s HuCNS-SC cells are purified, expanded in culture, cryopreserved, and then stored as banks of cells, ready to be made into individual patient doses when needed.

StemCells, Inc. is currently engaged in clinical development of its HuCNS-SC® platform technology (purified human neural stem cells) as a potential treatment for chronic spinal cord injury (SCI). The Company's Pathway Study, a Phase II proof-of-concept trial in cervical SCI is actively enrolling at twelve sites. Six-month interim data for the first cohort of the Pathway Study showed the first-ever clinical evidence of a treatment effect improving both muscle strength and motor function following cellular transplant in spinal cord injury. Top-line data from the Company's Phase I/II clinical trial in in chronic thoracic spinal cord injury showed measureable gains involving multiple sensory modalities and segments in 7 of 12 patients enrolled in the study, including the conversion of two patients from the complete AIS A injury to the incomplete AIS B injury post-transplant. The Company has also completed its Phase I/II clinical trial in geographic atrophy dry age related macular degeneration. Top-line results from this study show a positive safety profile and favorable preliminary efficacy data. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company showed preliminary evidence of progressive and durable donor-derived myelination by MRI. A Phase 1 study in children with Batten disease showed that transplantation of the cells into the brain was safe and resulted in long term survival of the cells.