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

University of Zurich12 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Spinal Cord Injuries

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitätsklinik Balgrist

Zurich, Switzerland

Outcomes

Primary Outcomes

American Spinal Injury Association (ASIA) Impairment Scale Improvement

Evidence of improvement in ASIA impairment scale as confirmed by neurological examination

Time frame: 36 months after transplantation of HuCNS-SC®

Data from ClinicalTrials.gov

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