Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT01321333
Status:
COMPLETED
Last Update Posted:
2015-06-18
First Post:
2011-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury
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': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-16', 'studyFirstSubmitDate': '2011-03-21', 'studyFirstSubmitQcDate': '2011-03-22', 'lastUpdatePostDateStruct': {'date': '2015-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Types and frequencies of adverse events and serious adverse events', 'timeFrame': 'One year after transplant', 'description': 'Analysis of types and frequencies of adverse events one year after transplant.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['thoracic spinal cord injury', 'spinal cord injury thoracic', 'sub-acute spinal cord injury', 'human neural stem cells', 'stem cells', 'stem cells transplant', 'stem cells transplant spinal cord injury'], 'conditions': ['Thoracic Spinal Cord Injury', 'Spinal Cord Injury', 'Spinal Cord Injury Thoracic', 'Spinal Cord Trauma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stemcellsinc.com/Therapeutic-Programs/Overview.htm', 'label': 'Click here for more information on this study'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of single transplantation of HuCNS-SC cells into the thoracic spinal cord of patients with sub-acute spinal cord injury.', 'detailedDescription': 'Study subjects will receive immunosuppression for nine months following transplantation. All enrolled subjects will be followed for one year following transplantation and then will be enrolled in a separate long-term follow-up study for an additional four years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T2-T11 thoracic spinal cord injury based on American Spinal Injury Association (ASIA) level determination by the principal investigator (PI)\n* T2-T11 thoracic spinal cord injury as assessed by magnetic resonance imaging (MRI) and/or computerized tomography (CT)\n* ASIA Impairment Scale (AIS) Grade A, B, or C\n* Minimum of six weeks post injury for the initiation of screening\n* Must have evidence of preserved conus function\n* Must be at stable stage of medical recovery after injury\n\nExclusion Criteria:\n\n* History of traumatic brain injury without recovery\n* Penetrating spinal cord injury\n* Evidence of spinal instability or persistent spinal stenosis and/or compression related to initial trauma\n* Previous organ, tissue or bone marrow transplantation\n* Previous participation in any gene transfer or cell transplant trial\n* Current or prior malignancy'}, 'identificationModule': {'nctId': 'NCT01321333', 'briefTitle': 'Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'StemCells, Inc.'}, 'officialTitle': 'A Phase I/II Study of the Safety and Preliminary Efficacy of Intramedullary Spinal Cord Transplantation of Human Central Nervous System (CNS) Stem Cells (HuCNS-SC®) in Subjects With Thoracic (T2-T11) Spinal Cord Trauma', 'orgStudyIdInfo': {'id': 'CL-N02-SC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HuCNS-SC cells', 'description': 'Single dose intramedullary administration of HuCNS-SC cells', 'interventionNames': ['Biological: HuCNS-SC cells']}], 'interventions': [{'name': 'HuCNS-SC cells', 'type': 'BIOLOGICAL', 'otherNames': ['Human central nervous system stem cells', 'allogeneic stem cells'], 'description': 'single dose intramedullary transplantation of HuCNS-SC cells in the thoracic spinal cord', 'armGroupLabels': ['HuCNS-SC cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N-2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Center', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '8008', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Stephen Huhn, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'StemCells, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'StemCells, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}