Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-02-22 @ 3:55 PM
Study NCT ID:
NCT00138268
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2005-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study Freeze and Transport Immune Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D011051', 'term': 'Poliomyelitis'}, {'id': 'D013742', 'term': 'Tetanus'}], 'ancestors': [{'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D003015', 'term': 'Clostridium Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2005-02'}, 'lastUpdateSubmitDate': '2010-08-26', 'studyFirstSubmitDate': '2005-08-26', 'studyFirstSubmitQcDate': '2005-08-26', 'lastUpdatePostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-30', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['umbilical cord blood, vaccine, pregnant women'], 'conditions': ['Diphtheria', 'Hepatitis B', 'Pertussis', 'Poliomyelitis', 'Tetanus']}, 'descriptionModule': {'briefSummary': 'To evaluate and standardize umbilical cord specimen collection and laboratory procedures to evaluate cellular and serological immune responses in neonates and young infants', 'detailedDescription': 'To evaluate: 1) The procedures for obtaining umbilical cord blood; 2) the methods for ensuring immune cell viability, freezing, and shipping; 3) the conditions for optimization of immune cell isolation procedures.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor the portion of the pilot study conducted at the UCLA CVR, an umbilical cord blood sample will be obtained from approximately 8 to 12 healthy pregnant women who are delivering neonates at the Obstetrical delivery ward of Harbor- UCLA Medical Center. Informed consent will not be obtained because the blood will be obtained after delivery from a clamped umbilical cord attached to the placenta (afterbirth) that otherwise would be discarded.\n\nExclusion Criteria:\n\nA cord blood sample will not be collected from women who have requested special arrangements for a cord blood registry service.'}, 'identificationModule': {'nctId': 'NCT00138268', 'briefTitle': 'Pilot Study Freeze and Transport Immune Cells', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Pilot Study to Optimize and Standardize Umbilical Cord Blood Collection and the Isolation, Freezing and Transportation of Cells for Studies of Cellular Immune Responses to Immunization', 'orgStudyIdInfo': {'id': '03-236'}}, 'contactsLocationsModule': {'locations': [{'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Center For Vaccine Research', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}}}}