Phase II Pathway Study Transplant by Miami Project Doctors Into First Participant
StemCells, Inc. Phase II Pathway Study trial the first to assess efficacy of neural stem cells in cervical spinal cord injury
December 18, 2014 – 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 transplanted the first subject in the Phase II Pathway® study assessing the efficacy of StemCells, Inc.’s proprietary human neural stem cells, HuCNS-SC®, for the treatment of cervical spinal cord injuries (SCI). The first transplant was performed at the University of Miami Hospital within the University of Miami 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.
“Our center is a leader in clinical research aimed at curing paralysis, and we are excited to be participating in this approach to spinal cord injury repair. The first subject transplanted tolerated the procedure and is doing well.” 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. “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.”
The Pathway Study is the first clinical trial designed to evaluate both the safety and efficacy of transplanting neural stem cells into patients with traumatic injury to the cervical spinal cord. 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 approximately 52 subjects.
The Company completed enrollment in the open-label Phase I/II study in thoracic SCI earlier this year and has reported interim results on all twelve subjects each having at least six months of follow-up post transplantation. 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 to an incomplete injury and it has been further observed that one subject with an incomplete injury has shown signs of voluntary toe movement. The interim results also continue to confirm the favorable safety profile of the cells and the surgical procedure.