Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-27 @ 7:28 AM
Study NCT ID:
NCT01506258
Status:
UNKNOWN
Last Update Posted:
2012-01-19
First Post:
2012-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Stem Cells in Newborns With Oxygen Deprivation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D002534', 'term': 'Hypoxia, Brain'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}, {'id': 'D000071700', 'term': 'Cone-Rod Dystrophies'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System 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'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-18', 'studyFirstSubmitDate': '2012-01-05', 'studyFirstSubmitQcDate': '2012-01-05', 'lastUpdatePostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of Stem Cell Infusion at 1 week after discharge', 'timeFrame': '1 week', 'description': 'Clinical assessment, including the Amiel-Tison Neurological Assessment'}, {'measure': 'Effects of Stem Cell Infusion at 1 year after discharge', 'timeFrame': '1 year', 'description': 'Clinical assessment, including the Amiel-Tison Neurological Assessment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CD34+', 'perinatal hypoxia', 'autologous hematopoietic stem cells', 'cord and placental blood', 'cerebral palsy'], 'conditions': ['Apgar; 0-3 at 1 Minute', 'Metabolic Acidosis', 'Hypoxia, Brain', 'Multiple Organ Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the plasticity of autologous intravenous application of cord blood stem cells would improve the clinical course of asphyxiated newborns.', 'detailedDescription': 'When there is oxygen deprivation, more frequently in premature newborns, the brain and other organs suffer severe consequences. There is evidence that hematopoietic stem cells can help in this scenario by promoting the release of growth-enhancing factors that can help control the damage due to their "homing" capacity, which attracts them to injured sites.\n\nCord and placental blood have a high concentration of these stem cells, and because its obtention is relatively easy, it seems like a feasible treatment in perinatal hypoxia.\n\nThere are current clinical trials that use cryopreserved cord blood for these patients but, to do that, the stem cells have to be frozen and then thawed to be infused, losing a considerable amount of stem cells (almost half of them). We want to evaluate the same condition but infusing non-cryopreserved autologous cord and placental blood because we believe it can be more beneficial due to the greater amount of cells infused, the avoidance of the cryoprotection agent´s toxicity and the lower costs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'minimumAge': '37 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apgar \\< 5 at 5 minutes\n* Mixed or metabolic acidosis with a pH \\<7.0 from umbilical cord blood sample\n* Neurological manifestations compatible with Hypoxic-Ischemic Encephalopathy\n* Any degree of organic/systemic affectation (cardiovascular, gastrointestinal, hematologic and/or respiratory)\n\nExclusion Criteria:\n\n* Neurodegenerative, autoimmune or genetic disease\n* Active infection at birth\n* Informed Consent not signed'}, 'identificationModule': {'nctId': 'NCT01506258', 'briefTitle': 'Autologous Stem Cells in Newborns With Oxygen Deprivation', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Dr. Jose E. Gonzalez'}, 'officialTitle': 'Effects of the Infusion of Autologous Non-cryopreserved CD34+ Cells in Newborns With Asphyxia', 'orgStudyIdInfo': {'id': 'HE-11-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Patients not infused with stem cells', 'description': 'Historic Controls', 'interventionNames': ['Procedure: Observation']}, {'type': 'EXPERIMENTAL', 'label': 'Patients infused with stem cells', 'interventionNames': ['Procedure: Application of Stem Cells']}], 'interventions': [{'name': 'Application of Stem Cells', 'type': 'PROCEDURE', 'otherNames': ['IV infusion of autologous cord and placental cord blood'], 'description': 'IV infusion of autologous stem cells within the first 48 hours after birth.', 'armGroupLabels': ['Patients infused with stem cells']}, {'name': 'Observation', 'type': 'PROCEDURE', 'otherNames': ['Comparison group'], 'description': 'Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.', 'armGroupLabels': ['Patients not infused with stem cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Consuelo Mancias-Guerra, MD', 'role': 'CONTACT', 'email': 'consuelo@mancias.com', 'phone': '+52 01 86 75 67 18'}, {'name': 'Alma R Marroquin-Escamilla, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ana Cecilia Sosa-Cortez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sagrario L Valdes-Burnes, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Barbara G Cardenas-del Castillo, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adriana Nieto-Sanjuanero, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Oscar Gonzalez-Llano, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Laura Villarreal-Martinez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Laura M Nuño-Vazquez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Josue E Rios-Solis, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Neonatology Department of the Pediatrics Service, Hospital Universitario Dr. Jose E. Gonzalez', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}], 'centralContacts': [{'name': 'Consuelo Mancias-Guerra, MD', 'role': 'CONTACT', 'email': 'consuelo@mancias.com', 'phone': '+52 81 83 48 61 36', 'phoneExt': '413'}, {'name': 'Alma R Marroquin-Escamilla, MD', 'role': 'CONTACT', 'email': 'arme25@yahoo.com', 'phone': '+52 81 83 48 61 36'}], 'overallOfficials': [{'name': 'Consuelo Mancias-Guerra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Dr. Jose E. Gonzalez'}, {'name': 'Alma R Marroquin-Escamilla, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario Dr. Jose E. Gonzalez'}, {'name': 'David Gómez-Almaguer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario Dr. Jose E. Gonzalez'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Dr. Jose E. Gonzalez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatric Hematology Professor', 'investigatorFullName': 'Consuelo Mancias Guerra', 'investigatorAffiliation': 'Hospital Universitario Dr. Jose E. Gonzalez'}}}}