Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT03558269
Status:
UNKNOWN
Last Update Posted:
2021-01-20
First Post:
2018-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Autologous Umbilical Cord Blood Treatment of Neonate With CHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D002303', 'term': 'Cardiac Output, Low'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessor will not be exposed to the participant group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-17', 'studyFirstSubmitDate': '2018-05-12', 'studyFirstSubmitQcDate': '2018-06-13', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuroimaging of the brain before and after the surgery (ref 1)', 'timeFrame': 'The time frame between MRI before and after surgery is 10-13 days', 'description': 'Change in MRI of the brain before (between 1-3 days) and after (10 days) the surgery between the intervention and control group. The change will be quantified by MRI brain injury severity (BIS) score quantifying white matter injury, stroke and brain hemorrhage. Diffusion tensor imaging measures will also be quantified by using average diffusivity and fractional anisotropy calculated from frontal, parietal, temporal and occipital white matter.'}], 'secondaryOutcomes': [{'measure': 'Neuro-development at one month', 'timeFrame': 'One month', 'description': 'General movements assessment (ref 2)'}, {'measure': 'Neuro-development at six month', 'timeFrame': '6 months', 'description': 'Gross Motor Function Measure 66 (ref 3)'}, {'measure': 'Neuro-development at 12 month', 'timeFrame': '12months', 'description': 'Gross Motor Function Measure 66 (ref 3)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autologous Umbilical cord blood infusion', 'Congenital Heart Disease', 'Brain Injuries', 'Low Cardiac Output Syndrome', 'Neonatal Disorder'], 'conditions': ['Congenital Heart Disease', 'Brain Injuries', 'Low Cardiac Output Syndrome', 'Neonatal Disorder']}, 'referencesModule': {'references': [{'pmid': '29468662', 'type': 'BACKGROUND', 'citation': 'Kwong AKL, Fitzgerald TL, Doyle LW, Cheong JLY, Spittle AJ. Predictive validity of spontaneous early infant movement for later cerebral palsy: a systematic review. Dev Med Child Neurol. 2018 May;60(5):480-489. doi: 10.1111/dmcn.13697. Epub 2018 Feb 22.'}, {'pmid': '23802141', 'type': 'BACKGROUND', 'citation': 'Alotaibi M, Long T, Kennedy E, Bavishi S. The efficacy of GMFM-88 and GMFM-66 to detect changes in gross motor function in children with cerebral palsy (CP): a literature review. Disabil Rehabil. 2014;36(8):617-27. doi: 10.3109/09638288.2013.805820. Epub 2013 Jun 26.'}, {'pmid': '23771484', 'type': 'RESULT', 'citation': 'Dimitropoulos A, McQuillen PS, Sethi V, Moosa A, Chau V, Xu D, Brant R, Azakie A, Campbell A, Barkovich AJ, Poskitt KJ, Miller SP. Brain injury and development in newborns with critical congenital heart disease. Neurology. 2013 Jul 16;81(3):241-8. doi: 10.1212/WNL.0b013e31829bfdcf. Epub 2013 Jun 14.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the feasibility and safety and efficacy of collecting and infusing autologous umbilical cord blood (UCB) in newborn infants with hypoplastic left heart syndrome (HLHS) and transposition of great arteries (TGA).\n\nRationale: Neonates with HLHS and TGA have significant brain injury as demonstrated by peri-surgical MRI. Moreover, there a substantial tendency to suffer from chronic cardiac condition as low cardiac output state and valvular insufficiency. Treatment of neonates after hypoxic ischemic injury at birth with autologous UCB was shown to safe and improved developmental outcome. The effect of UCB is most likely achieved by reduction of free radicals injury and pro-inflammatory and apoptotic process.\n\nHypothesis: Treatment with UCB immediately after the first cardiac surgey, with in the first week life will reduce the brain injury demonstrated by MRI and reduce the choronic cardiac problems', 'detailedDescription': 'The aim of this pilot study is to evaluate the safety and feasibility of infusion of autologous umbilical cord blood (UCB) in neonates with with hypoplastic left heart syndrome (HLHS) or transposition of great arteries (TGA).\n\nThis is a prospective, matched control study, Phase I-II trial to evaluate the safety and efficacy of autologous UCB infusion in neonates with HLHS or TGA. The study group will consist of neonate that were diagnosed by prenatal fetal ultrasound with HLHS or TGA and their UCB was collected at the time of delivery.\n\nThe study group will include the patients with UCB and the control group will be patients without UCB.\n\nAll patients will have their surgery within 2 weeks from birth. The UCB will be infused to the patients in study group as soon as the patient has stabilized after the surgery and not more than 7 days after surgery.\n\nBoth groups will be followed similarity:\n\nDuring hospitalization:\n\nNeurological and cardiac evaluation a day before surgery, 7 days after surgery and at discharge.\n\nBlood tests for immune and growth factors a day before surgery, at the time of infusion (or intended infusion for the control group) ,1 and 7 days after infusion.\n\nhave a cardiac and brain MRI before the surgery and within 14 days after surgery.\n\nBrain and cardiac MRI before surgery, 7-14 days after surgery.\n\nAmbulatory follow up (similar to routine follow up):\n\nCardiac and neuro-developmental evaluation at 1,6,12 month Blood tests for immune and growth factors at 1 month'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '3 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 35 weeks of gestation\n2. Prenatal diagnosis of HLHS including mitral stenosis/atresia, aortic stenosis/atresia, arch hypoplasia and the presence of hypoplastic left ventricle with or without VSD.\n3. Norwood procedure will take place within 14 days from birth.\n4. Treatment with cord blood should be given within 7 days after surgery.\n5. Parental informed consent for collection of umbilical cord blood.\n\nExclusion Criteria:\n\n1. Total nucleated cells (TNC) lower than 1X107 in the collected umbilical cord blood unit.\n2. Infected umbilical cord blood unit.\n3. Parents refusal to continue in the study at any stage.'}, 'identificationModule': {'nctId': 'NCT03558269', 'briefTitle': 'Autologous Umbilical Cord Blood Treatment of Neonate With CHD', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Pilot Study to Assess the Efficacy of Autologous Umbilical Cord Blood Treatment of Brain and Heart Injury in Neonates With Congenital Heart Defect', 'orgStudyIdInfo': {'id': '3757-16-SMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'This group will receive UCB after the first palliative surgery', 'interventionNames': ['Biological: Autlogous UCB infusion']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'This group will not receive any treatment'}], 'interventions': [{'name': 'Autlogous UCB infusion', 'type': 'BIOLOGICAL', 'description': 'Infants delivered with hypoplastic left heart syndrome and transposition of great arteries undergoing surgery in the 1st 2 weeks of life will be treated with autologous UCB after the surgery. Each group will be followed by MRI before (1-3 days) and after the surgery between at 10 POD. Developmental follow up will be done at 1, 6 and 12 months. Another brain MRI will be done at 6 months of age.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5621000', 'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Omer Bar-Yosef, M.D._Ph.D.', 'role': 'CONTACT', 'email': 'omer.baryosef@sheba.health.gov.il', 'phone': '+972-3-5302687'}, {'name': 'Omer Bar-Yosef, M.D.-Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amir Vardi, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elad Jacobi, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tal Tirosh, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yishai Salem, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Mishali, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Omer Bar-Yosef, M.D.-Ph.D.', 'role': 'CONTACT', 'email': 'omer.baryosef@sheba.health.gov.il', 'phone': '972-3-5302687'}, {'name': 'Amir Vardi, M.D.', 'role': 'CONTACT', 'email': 'amir.vardi@sheba.health.gov.il', 'phone': '972-3-5308010'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'By excel data base'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Omer Bar-Yosef', 'investigatorAffiliation': 'Sheba Medical Center'}}}}