INSTrUCT-SCI: INdependent Observational STUdy of Cell Transplantation in SCI
Completed
- Conditions
- Spinal Cord Injuries
- Registration Number
- NCT03069404
- Lead Sponsor
- University of Zurich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universitätsklinik Balgrist
🇨🇭Zürich, Switzerland