INSTrUCT-SCI: INdependent Observational STUdy of Cell Transplantation in SCI

University of Zurich (UZH)

Status: Completed

Conditions: Spinal Cord Injuries

Study type: Observational

Funder types: Other

Identifiers

NCT03069404

INSTrUCT-SCI

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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