Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-03 @ 2:53 AM
Study NCT ID:
NCT02915406
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2017-08-16
First Post:
2016-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
cliniMACs HUD for T Cell Depletion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053632', 'term': 'X-Linked Combined Immunodeficiency Diseases'}], 'ancestors': [{'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D016511', 'term': 'Severe Combined Immunodeficiency'}, {'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'lastUpdateSubmitDate': '2017-08-12', 'studyFirstSubmitDate': '2016-09-23', 'studyFirstSubmitQcDate': '2016-09-23', 'lastUpdatePostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['x Linked Combined Immunodeficiency']}, 'descriptionModule': {'briefSummary': 'This protocol is designed to enable access to related or unrelated CD34 cells manufactured using the CliniMACS (Miltenyi) under the HUD designation for patients needing T cell depleted allogeneic grafts for hematopoietic stem cell transplant (HSCT). This will include patients with inherited immunodeficiency disorders as well as patients with malignancies, bone marrow failure, and other rare diseases amenable to HSCT. Finally, patients with poor graft function and Graft Versus Host Disease(GVHD) after a previous HSCT may require a boost of T-cell depleted donor Peripheral Blood Stem Cell (PBSCs) or bone marrow cells that are CD34 selected using the CliniMACS device ENROLLMENT BY INVITATION ONLY'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\nsevere combined immune deficiency need for stem cell boost\n\nExclusion Criteria:\n\nn/a'}, 'identificationModule': {'nctId': 'NCT02915406', 'briefTitle': 'cliniMACs HUD for T Cell Depletion', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'cliniMACs HUD for T Cell Depletion', 'orgStudyIdInfo': {'id': '20160472'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CliniMACs', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Gary Kleiner, MDPhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jackson Health System', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Gary Kleiner', 'investigatorAffiliation': 'University of Miami'}}}}