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

INSTrUCT-SCI: INdependent Observational STUdy of Cell Transplantation in SCI, an Investigator Initiated Trial

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 Overview

• Status: Completed
• Conditions: Spinal Cord Injuries

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland
    • Universitätsklinik Balgrist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Spinal cord injured patients T2-T11

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Spinal Injury Association (ASIA) Impairment Scale Improvement	Evidence of improvement in ASIA impairment scale as confirmed by neurological examination	36 months after transplantation of HuCNS-SC®

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Foundation Wings For Life
• Investigators: Principal Investigator: Armin Curt, MD, Universitätsklinik Balgrist

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: INSTrUCT-SCI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No