Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-30 @ 12:06 AM
Study NCT ID:
NCT01235468
Status:
WITHDRAWN
Last Update Posted:
2015-12-03
First Post:
2010-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Israel', 'Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'loss of support', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2010-11-02', 'studyFirstSubmitQcDate': '2010-11-04', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '1 month', 'description': 'Number of patients with adverse events during infusion'}, {'measure': 'engraftment', 'timeFrame': '3 months', 'description': 'Time to engraftment'}, {'measure': 'treatment-related toxicity', 'timeFrame': '3 months', 'description': 'Type and severity of adverse events after transplantation using the NCI CTC scale'}, {'measure': 'GVHD', 'timeFrame': '1 year', 'description': 'Number of patients with acute and chronic GVHD after transplantation'}], 'secondaryOutcomes': [{'measure': 'Immunological reconstruction', 'timeFrame': '5 years', 'description': 'immunological reconstruction after transplantation measured by lymphocyte number and function'}, {'measure': 'relapse', 'timeFrame': '5 years', 'description': 'rate of disease recurrence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['umbilical cord blood', 'ex vivo expansion', 'engraftment', 'GVHD'], 'conditions': ['Umbilical Cord Blood', 'Stem Cell Transplantation', 'Hematological Malignancies']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.', 'detailedDescription': 'Stem cell transplantation is a curative approach for patients with hematological malignancies. Umbilical cord blood is a source of stem cells for transplantation in patients with no related donor. However, in adults, the number of stem cells in a single unit, may be too low to allow engraftment, and the time to engraftment may be prolonged, increasing the risks of the transplant. In this study, we expand part of the cord blood unit, in the lab, trying to increase unit size, such that it would be suitable for adults, and would allow safe engraftment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* hematological malignancy\n* standard indication for allogeneic transplantation\n* expected survival time over 12 weeks\n* no related or unrelated donor\n* availability of a cord blood unit of compatible placental blood cryopreserved in at least 2 different bags; one of the two units should have a cellular content at least equal to the minimum dose of 2 x 107 nucleated cells per kilogram of body weight\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status \\>2\n* Prior allogeneic transplantation\n* Pregnant or nursing women\n* Positive serology for hepatitis B or C\n* HIV positive\n* Left ventricular ejection fraction \\< 50%\n* DLCO \\< 50%\n* Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study\n* Treatment with other investigational drugs within 4 weeks of enrolling in this protocol'}, 'identificationModule': {'nctId': 'NCT01235468', 'briefTitle': 'Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Allogenic Transplantation of Ex-vivo Expanded CB Progenitors for Haematological Disorders', 'orgStudyIdInfo': {'id': 'SHEBA-10-7959-AN-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CB expnasion', 'description': 'ex-vivo expansion of cord blood for transplantation', 'interventionNames': ['Biological: ex vivo expansion']}], 'interventions': [{'name': 'ex vivo expansion', 'type': 'BIOLOGICAL', 'description': 'ex-vivo expansion of cord blood for transplantation', 'armGroupLabels': ['CB expnasion']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Arnon Nagler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chaim Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Avichai Shimoni MD', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. Avichai Shimoni, hematologist', 'investigatorFullName': 'Dr. Avichai Shimoni MD', 'investigatorAffiliation': 'Sheba Medical Center'}}}}