Spinal Cord InjuriesNCT03069404
INSTrUCT-SCI: INdependent Observational STUdy of Cell Transplantation in SCI
An observational study of Spinal Cord Injuries, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2017to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Spinal cord injured patients T2-T11
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Spinal Cord Injuries
- Medical subject headings
- Spinal Cord Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
American Spinal Injury Association (ASIA) Impairment Scale Improvement
Evidence of improvement in ASIA impairment scale as confirmed by neurological examination
Measured: 36 months after transplantation of HuCNS-SC®
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Aug 2017
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Wings For Life
- Responsible party
- Sponsor
- Investigators
- Armin Curt, MD, Principal investigator, Universitätsklinik Balgrist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069404
- Sponsor's protocol ID
- INSTrUCT-SCI
- Status last verified
- May 2020
- First submitted
- 9 Feb 2017
- Last updated
- 15 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSTrUCT-SCI: INdependent Observational STUdy of Cell Transplantation in SCI, an Investigator Initiated Trial
- ClinicalTrials.gov ID
- NCT03069404
- Acronym / sponsor ID
- INSTrUCT-SCI
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Foundation Wings For Life
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Spinal cord injured patients T2-T11
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin Curt, MD principal investigator
Universitätsklinik Balgrist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Spinal Injury Association (ASIA) Impairment Scale Improvement (time frame: 36 months after transplantation of HuCNS-SC®). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.