Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects
The purpose of this study is to determine the long term safety and preliminary efficacy of intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord trauma.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Long-term Follow-up (LTFU) Study of the Phase I/II Safety and Preliminary Efficacy Investigation of Intramedullary Spinal Cord Transplantation of HuCNS-SC® in Subjects With Thoracic (T2-T11) Spinal Cord Trauma|
- American Spinal Injury Association (ASIA) Impairment Scale Improvement [ Time Frame: Four years ] [ Designated as safety issue: No ]Evidence of improvement in ASIA impairment scale as confirmed by neurological examination
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
The investigation is a multi-year observational study following the completion of the open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC cells into 12 subjects with thoracic spinal cord injury.
Subjects will be monitored at routine intervals for safety and preliminary efficacy for four years. The LTFU study will commence following the one year post-transplantation termination visit of the Phase I/II investigation.