An observational study in Spinal Cord Injury, sponsored by StemCells, Inc.. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-06-03.
Sponsored by StemCells, Inc. · Observational
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 323 observational studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →StemCells, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects who had undergone intramedullary transplantation of HuCNS-SC cells in the thoracic region.
Exclusion Criteria:
Observation
Other: Observation
American Spinal Injury Association (ASIA) Impairment Scale Improvement
Evidence of improvement in ASIA impairment scale as confirmed by neurological examination
Time frame: Four years
This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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StemCells, Inc.