Spinal Cord Injuries
Conditions
Brief summary
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 5 years post-transplantation of the Phase I/II investigation CL-N02-SC.
Interventions
None listed
Sponsors
Foundation Wings For Life
University of Zurich
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Must have undergone HuCNS-SC transplantation as a subject in the Phase I/II trial * Must be able to provide written informed consent prior to any study related procedures * Must agree to comply in good faith with all conditions of the study and to attend all required study visits * Female subjects who are pregnant remain eligible for enrollment, but the MRI examination will not be performed during the pregnancy. Female subjects of child-bearing potential must have a negative urine pregnancy test prior to the MRI examination
Exclusion criteria
* Subjects have received or are receiving off-protocol immunosuppressive medications * Subjects who after completion of CL-N02-SC have entered, or are about to enter any other interventional study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Spinal Injury Association (ASIA) Impairment Scale Improvement | 36 months after transplantation of HuCNS-SC® | Evidence of improvement in ASIA impairment scale as confirmed by neurological examination |
Countries
Switzerland
Outcome results
None listed