Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-25 @ 2:35 AM
Study NCT ID:
NCT02039557
Status:
COMPLETED
Last Update Posted:
2024-10-23
First Post:
2014-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Follow Up Protocol for NiCord®/CordIn™ (Omidubicel) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2014-01-13', 'studyFirstSubmitQcDate': '2014-01-15', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'long term sustained chimerism of NiCord®/CordIn™ (omidubicel) transplantation', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patients Transplanted With NiCord/CordIn (Omidubicel)']}, 'descriptionModule': {'briefSummary': 'This is an observational study that will monitor clinical outcomes of patients who have received a NiCord®/CordIn™ (omidubicel) transplant as part of a GC clinical interventional study and meet the eligibility criteria for this Long Term Follow Up study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'NiCord® (ages 12-65)/CordIn™ (ages 2-25) (omidubicel) transplanted patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Anyone who has received a NiCord®/CordIn™ (omidubicel) transplant, completed study specific follow up, and has signed the consent for this study.\n\nExclusion Criteria\n\n* None'}, 'identificationModule': {'nctId': 'NCT02039557', 'briefTitle': 'Long Term Follow Up Protocol for NiCord®/CordIn™ (Omidubicel) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gamida Cell ltd'}, 'officialTitle': 'Long Term Follow Up for Patients Who Have Received Allogeneic Stem Cell Transplantation of NiCord®/CordIn™, Umbilical Cord Blood-derived Ex Vivo Expanded Stem and Progenitor Cells', 'orgStudyIdInfo': {'id': 'GC P# 04.01.020/030'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NiCord®/CordIn™ (omidubicel) transplanted', 'description': 'Anyone who signed the consent for this study received a NiCord®/CordIn™ (omidubicel) infusion as part of a GC clinical interventional study, and completed the interventional study Day 365 status assessment.', 'interventionNames': ['Genetic: NiCord®/CordIn™ (omidubicel)']}], 'interventions': [{'name': 'NiCord®/CordIn™ (omidubicel)', 'type': 'GENETIC', 'armGroupLabels': ['NiCord®/CordIn™ (omidubicel) transplanted']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "UCSF Benioff Children's Hospital", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University, Cardinal Bernardin Cancer Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '37240', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '3503 AB', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Cancer Institute', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "University Hospital Vall D'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gamida Cell ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}