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Completed

NCT Number: NCT03069404

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinik Balgrist

Zurich, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Foundation Wings For Life

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2017
Registry last updated
May 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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