SCHWANN CELL CLINICAL TRIAL FOR CHRONIC SCI APPROVED BY THE FDA
October 2014 – The Miami Project to Cure Paralysis, at the University of Miami Miller School of Medicine has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase I clinical trial to evaluate the safety of autologous human Schwann cell transplantation in the chronic spinal cord injury (SCI) setting.
The clinical protocol of the Phase I trial is focused on safety and feasibility outcomes. The investigative team is already conducting a Phase I trial assessing safety of autologous Schwann cell transplantation in individuals with subacute SCI. The new trial will be conducted in parallel and focus on individuals with chronic SCI. Individuals that are at least 1 year post-injury will have to meet the inclusion/exclusion criteria and agree to participate in the trial, which initially will require approximately 10 months of their time. Participants will be monitored long-term for a total of five years. Each participant’s own Schwann cells will be obtained from a sural nerve biopsy. The Schwann cells will then need to be derived from the nerve and processed in a culturing facility to generate the number of cells necessary for transplantation, and to undergo a purification process. The cell therapy will be combined with an intense exercise and rehabilitation intervention to maximize outcome.
MIAMI PROJECT DOCTORS TRANSPLANT FIRST PARTICIPANT IN STEMCELLS, INC. PATHWAY STUDY
Phase II trial the first study to assess efficacy of neural stem cells in cervical spinal cord injury
December 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.”
Wednesday - January 7, 2015
Gail F. Beach Memorial Visiting Lectureship Series
LPLC 7th Floor Apex Auditorium
Rehabilitation Research Director, Kentucky Spinal Cord Injury Research Center
Owsley B. Frazier Chair , Department of Neurological Rehabilitation
Professor, Department of Neurological Surgery
Frazier Rehab Institute- Louisville, KY
2014-2015 Lecture Schedule