Spinal Cord Injury Clinical Trial
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
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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