Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-03-04 @ 8:38 PM
Study NCT ID:
NCT03069404
Status:
COMPLETED
Last Update Posted:
2020-05-15
First Post:
2017-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INSTrUCT-SCI: INdependent Observational STUdy of Cell Transplantation in SCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-14', 'studyFirstSubmitDate': '2017-02-09', 'studyFirstSubmitQcDate': '2017-02-27', 'lastUpdatePostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Spinal Injury Association (ASIA) Impairment Scale Improvement', 'timeFrame': '36 months after transplantation of HuCNS-SC®', 'description': 'Evidence of improvement in ASIA impairment scale as confirmed by neurological examination'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': '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.\n\nSubjects 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Spinal cord injured patients T2-T11', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have undergone HuCNS-SC transplantation as a subject in the Phase I/II trial\n* Must be able to provide written informed consent prior to any study related procedures\n* Must agree to comply in good faith with all conditions of the study and to attend all required study visits\n* 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\n\nExclusion Criteria:\n\n* Subjects have received or are receiving off-protocol immunosuppressive medications\n* Subjects who after completion of CL-N02-SC have entered, or are about to enter any other interventional study'}, 'identificationModule': {'nctId': 'NCT03069404', 'briefTitle': 'INSTrUCT-SCI: INdependent Observational STUdy of Cell Transplantation in SCI', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'INSTrUCT-SCI: INdependent Observational STUdy of Cell Transplantation in SCI, an Investigator Initiated Trial', 'orgStudyIdInfo': {'id': 'INSTrUCT-SCI'}}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitätsklinik Balgrist', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Armin Curt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinik Balgrist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation Wings For Life', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}