Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-03-04 @ 5:18 AM
Study NCT ID:
NCT02256618
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2014-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020925', 'term': 'Hypoxia-Ischemia, Brain'}], 'ancestors': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002534', 'term': 'Hypoxia, Brain'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-28', 'studyFirstSubmitDate': '2014-10-01', 'studyFirstSubmitQcDate': '2014-10-01', 'lastUpdatePostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse event rates', 'timeFrame': 'first 30 postnatal days', 'description': 'Adverse event rates (combined rate of death, continuous respiratory support, and continuous use of vasopressor) will be compared between the cell recipients and historical controls at 30 days of age.'}], 'secondaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '18 months', 'description': 'Neuroimaging at 12 months of age and neurodevelopmental function at 18 months of age will be compared between the cell recipients and historical controls.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['neonatal encephalopathy', 'hypoxic-ischemic encephalopathy', 'newborn infants', 'neonates', 'umbilical cord blood cells'], 'conditions': ['Neonatal Encephalopathy', 'Hypoxic-ischemic Encephalopathy']}, 'referencesModule': {'references': [{'pmid': '24444827', 'type': 'BACKGROUND', 'citation': 'Tsuji M, Taguchi A, Ohshima M, Kasahara Y, Sato Y, Tsuda H, Otani K, Yamahara K, Ihara M, Harada-Shiba M, Ikeda T, Matsuyama T. Effects of intravenous administration of umbilical cord blood CD34(+) cells in a mouse model of neonatal stroke. Neuroscience. 2014 Mar 28;263:148-58. doi: 10.1016/j.neuroscience.2014.01.018. Epub 2014 Jan 18.'}, {'pmid': '25034178', 'type': 'BACKGROUND', 'citation': 'Ohshima M, Taguchi A, Tsuda H, Sato Y, Yamahara K, Harada-Shiba M, Miyazato M, Ikeda T, Iida H, Tsuji M. Intraperitoneal and intravenous deliveries are not comparable in terms of drug efficacy and cell distribution in neonatal mice with hypoxia-ischemia. Brain Dev. 2015 Apr;37(4):376-86. doi: 10.1016/j.braindev.2014.06.010. Epub 2014 Jul 14.'}, {'pmid': '15286799', 'type': 'BACKGROUND', 'citation': 'Taguchi A, Soma T, Tanaka H, Kanda T, Nishimura H, Yoshikawa H, Tsukamoto Y, Iso H, Fujimori Y, Stern DM, Naritomi H, Matsuyama T. Administration of CD34+ cells after stroke enhances neurogenesis via angiogenesis in a mouse model. J Clin Invest. 2004 Aug;114(3):330-8. doi: 10.1172/JCI20622.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot study to test feasibility and safety of intravenous infusion of autologous umbilical cord blood cells in the first 72 hours after birth if a neonate is born with signs of encephalopathy.', 'detailedDescription': "This is a multicenter pilot study to evaluate the feasibility and safety of intravenous infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). If a neonate is born with signs of moderate to severe encephalopathy and cooled for the encephalopathy, the neonate can receive their own non-cryopreserved volume- and red blood cell-reduced cord blood cells. The cord blood cells are divided into 3 doses and infused at 12-24, 36-48, and 60-72 hours after the birth. Infants will be followed for safety and neurodevelopmental outcome up to 18 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInfants are eligible if they meet all the following inclusion criteria except 4.\n\n1. ≥36 weeks gestation\n2. Either a 10-minute Apgar score ≤5, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as pH \\<7.0 or base deficit ≥16 mmol/L in a sample of umbilical cord blood or any blood during the first hour after birth\n3. Moderate to severe encephalopathy (Sarnat II to III)\n4. A moderately or severely abnormal background amplitude-integrated EEG (aEEG) voltage, or seizures identified by aEEG, if monitored\n5. Up to 24 hours of age\n6. Autologous umbilical cord blood available to infuse within 3 days after birth\n7. A person with parental authority must have consented for the study.\n\nExclusion Criteria:\n\n1. Known major congenital anomalies, such as chromosomal anomalies, heart diseases\n2. Major intracranial hemorrhage identified by brain ultrasonography or computed tomography\n3. Severe growth restriction, with birth-weight less than 1800 g\n4. Severe infectious disease, such as sepsis\n5. Hyperkalemia\n6. Outborn infants (Infants born at hospitals other than the study sites)\n7. Volume of collected cord blood \\<40 ml\n8. Infants judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist'}, 'identificationModule': {'nctId': 'NCT02256618', 'briefTitle': 'Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy', 'organization': {'class': 'NETWORK', 'fullName': 'Neonatal Encephalopathy Consortium, Japan'}, 'officialTitle': 'A Pilot Feasibility and Safety Study of Autologous Umbilical Cord Blood Cell Therapy in Infants With Neonatal Encephalopathy', 'orgStudyIdInfo': {'id': 'UMIN000014903'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cell therapy', 'description': 'Infants who are born at the study sites, have moderate to severe encephalopathy, and have cord blood available for infusion', 'interventionNames': ['Other: Autologous umbilical cord blood cells']}], 'interventions': [{'name': 'Autologous umbilical cord blood cells', 'type': 'OTHER', 'description': 'Autologous non-cryopreserved volume- and red blood cell-reduced cord blood cells will be intravenously infused', 'armGroupLabels': ['Cell therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '466-8560', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nagoya University Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '710-8602', 'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Kurashiki Central Hospital', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'zip': '350-0495', 'city': 'Kawagoe', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Medical University', 'geoPoint': {'lat': 35.90861, 'lon': 139.48528}}, {'zip': '533-0032', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Yodogawa Christian Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '534-0021', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka City General Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '545-8585', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka City University', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Haruo Shintaku, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Osaka City University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neonatal Encephalopathy Consortium, Japan', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Osaka City University', 'class': 'OTHER'}, {'name': 'Yodogawa Christian Hospital', 'class': 'OTHER'}, {'name': 'Kurashiki Central Hospital', 'class': 'OTHER'}, {'name': 'Nagoya University', 'class': 'OTHER'}, {'name': 'Osaka City General Hospital', 'class': 'OTHER'}, {'name': 'Saitama Medical University', 'class': 'OTHER'}, {'name': 'National Cerebral and Cardiovascular Center, Japan', 'class': 'OTHER'}, {'name': 'National Center for Child Health and Development, Japan', 'class': 'UNKNOWN'}, {'name': 'Tokyo University', 'class': 'OTHER'}, {'name': "Tokyo Women's Medical University", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}