Spinal Cord Injury
Conditions
Keywords
Spinal Cord Injury, HuCNS-SC cells, Human Neural Stem Cells, Neural Stem Cells, Stem Cells
Brief summary
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.
Detailed description
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.
Interventions
OTHERObservation
Sponsors
StemCells, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Must have undergone HuCNS-SC transplantation as a subject in the Phase I/II trial * Must agree to comply in good faith with all conditions of the study and to attend all required study visits
Exclusion criteria
* Subjects have received or are receiving off-protocol immunosuppressive medications * Subjects who, after completion of Phase I/II trial (Protocol # CL-N02-SC), have entered or are about to enter any other investigational study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Spinal Injury Association (ASIA) Impairment Scale Improvement | Four years | Evidence of improvement in ASIA impairment scale as confirmed by neurological examination |
Countries
Switzerland
Outcome results
None listed