The Miami Project’s Dr. Allan Levi to Begin Novel Stem Cell Trial
October 2014 – A novel clinical trial using human neural stem cells for the treatment of cervical spinal cord injury is beginning at the Miller School of Medicine. Allan D. Levi, M.D., Ph.D, professor and Robert M. Buck Distinguished Chair in Neurological Surgery, is the principal investigator of the Pathway® Study, which is the first clinical study designed to evaluate both the safety and efficacy of transplanting stem cells into patients with traumatic injury to the cervical spinal cord.
The trial will use HuCNS-SC® cells, purified human neural stem cells developed by StemCells, Inc., a leader in the research and development of cell-based therapies for the treatment of disorders of the central nervous system. 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 patients for one year from the time of enrollment.
Levi is a clinical researcher at The Miami Project to Cure Paralysis, a Center of Excellence at the Miller School, which is also conducting the first ever clinical trial of Schwann cell transplantation in patients with a new spinal cord injury among five other FDA approved clinical trials.
“Our center has been a leader in clinical research aimed at curing paralysis,” said Levi. “I have been involved in pioneering research efforts in applying cellular transplants to treat spinal cord injury patients for many years, and have closely followed the pre-clinical and clinical efforts of StemCells. We are excited to be the first site to open this important clinical trial. This is a time of promise and hope for victims of spinal cord injuries and, should this study be successful, it moves us one step closer to our ultimate goal of curing paralysis.”
Approximately 1.3 million people in the U.S. report being paralyzed due to a spinal cord injury (SCI), and there currently are no effective treatments available. Approximately 56 percent of the spinal cord injuries occur in the cervical region. Overall, approximately 13 percent of SCI patients have no mobility and 35 percent have limited mobility after the traumatic injury.
Earlier this year, StemCells, Inc. completed enrollment in an open-label Phase I/II clinical trial in thoracic SCI and reported interim results from this trial on eight patients with at least six months of follow-up post transplantation. Half of the patients transplanted had significant post-transplant gains in sensory function. The interim results also continue to confirm the favorable safety profile of the cells and the surgical procedure. Based upon the strength of the interim data from its thoracic SCI study, the company is initiating the first in human clinical trial to assess the efficacy of stem cell transplants for the treatment of cervical SCI.
“The initiation of the Pathway Study represents a major milestone for StemCells, Inc. as we pursue the development of a truly breakthrough therapy for spinal cord injury,” said Martin McGlynn, President and Chief Executive Officer of StemCells, Inc. “While we are thrilled by the prospect that patients with thoracic level injuries might be able to regain lost sensory function below the site of the injury, the possibility that patients with injuries to the cervical region of the cord might regain or improve lost motor function could be truly life-changing.”
The study will be conducted at the University of Miami Hospital and includes a multi-disciplinary team from across the University of Miami Hospital and Miller School of Medicine. In addition to Dr. Levi, the team includes Barth Green, M.D., Andrew L. Sherman, M.D., Alberto Martinez-Arizala, M.D., Kimberly Anderson-Erisman, Ph.D. and Marine Dididze, M.D., Ph.D. from Neurosurery; Diana Cardenas, M.D. and Kevin L. Dalal, M.D. from Rehabilitation Medicine; Robert Quencer, M.D. and Efrat Saraf-Lavi, M.D. from Radiology; Bruno V. Gallo, M.D., Kristine H. O’Phelan, M.D. and Carlos Francisco Blandino from Neurology; Jay R. Grossman, M.D. and Richard B. Silverman, M.D. from Anesthesiology; and George W. Burke, III, M.D., Gaetano Ciancio, M.D. and Dianna Noel Colabella from Surgery.