NCT03069404

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

2.7 years

First QC Date

February 9, 2017

Last Update Submit

May 14, 2020

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

  • 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®

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Spinal cord injured patients T2-T11

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik Balgrist

Zurich, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Armin Curt, MD

    Universitätsklinik Balgrist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

March 3, 2017

Study Start

August 1, 2017

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

May 15, 2020

Record last verified: 2020-05

Locations

CH(1)