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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069404
• Other study ID #: INSTrUCT-SCI
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Locations

Country	Name	City	State
Switzerland	Universitätsklinik Balgrist	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Foundation Wings For Life

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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®