NCT03069404CompletedNot Applicable
INSTrUCT-SCI: INdependent Observational STUdy of Cell Transplantation in SCI, an Investigator Initiated Trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- American Spinal Injury Association (ASIA) Impairment Scale Improvement
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
American Spinal Injury Association (ASIA) Impairment Scale Improvement
Time Frame: 36 months after transplantation of HuCNS-SC®
Evidence of improvement in ASIA impairment scale as confirmed by neurological examination
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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